Page last updated: 2024-12-08

lactitol

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Occurs in Manufacturing Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

lactitol : A glycosyl alditol consisting of beta-D-galactopyranose and D-glucitol joined by a 1->4 glycosidic bond. It is used as a laxative, as an excipient, and as replacement bulk sweetener in some low-calorie foods. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID157355
CHEMBL ID1661
CHEBI ID75323
SCHEMBL ID3849
MeSH IDM0063325

Synonyms (92)

Synonym
nsc231323
nsc-231323
585-86-4
NCGC00166295-01
einecs 209-566-5
ccris 7077
lactitolum [inn-latin]
lactitol
d-glucitol, 4-o-beta-d-galactopyranosyl-
nsc 231323
4-o-beta-d-galactopyranosyl-d-glucitol
262A7827-24F7-47EE-B528-3AF52CA860CE
importal (tn)
D08266
pizensy (tn)
lactitol (nf/inn)
lactosit
d-lactitol
miruhen
finlac dc
ins no.966
CHEMBL1661
lactositol
bli-400
e-966
lacty (saccharide)
lactitol acm 50
chebi:75323 ,
milchen
nsc-759131
lactobiosit
ins-966
lactitol anhydrous
(2s,3r,4r,5r)-4-[(2s,3r,4s,5r,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexane-1,2,3,5,6-pentol
importal
beta-d-galactopyranosyl-(1->4)-d-glucitol
HMS3264E13
emportal
oponaf
dsstox_rid_80133
tox21_112397
dsstox_gsid_44247
dsstox_cid_24247
cas-585-86-4
lacitol
pharmakon1600-01301027
nsc-760415
nsc760415
lactitol [inn:ban:nf]
lactit
hsdb 7970
unii-l2b0wjf7zy
l2b0wjf7zy ,
lactitolum
pizensy
S5368
4-o-.beta.-d-galactopyranosyl-d-glucitol
lactitol [orange book]
lactitol [who-dd]
lactitol [inn]
lactitol [usp-rs]
lactitol [inci]
lactitol [mi]
CCG-213712
SCHEMBL3849
tox21_112397_1
NCGC00263893-02
DTXSID9044247 ,
lactitol, analytical standard
W-109090
(2s,3r,4r,5r)-4-[(2s,3r,4s,5r,6r)-3,4,5-trihydroxy-6-methylol-tetrahydropyran-2-yl]oxyhexane-1,2,3,5,6-pentol
AB00698230_06
AKOS030228540
portolac
floralac
4-o-b-d-galactopyranosyl-d-glucitol, 9ci
DB12942
(2s,3r,4r,5r)-4-((2s,3r,4s,5r,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)tetrahydro-2h-pyran-2-yloxy)hexane-1,2,3,5,6-pentaol
Q415020
BRD-K40787673-001-02-1
A11574
(2s,3r,4r,5r)-4-(((2s,3r,4s,5r,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)tetrahydro-2h-pyran-2-yl)oxy)hexane-1,2,3,5,6-pentaol
CS-0069039
4-beta-d-galactopyranosyl-d-glucito1
HY-N7104
lactosit miruhen
wurcs=2.0/2,2,1/(h2122h)(a2112h-1b_1-5)/1-2/a4-b1
lactitolum (inn-latin)
4-beta-d-galactopyranosyl-d-sorbitol
lactitol (usp-rs)
(2s,3r,4r,5r)-4-{[(2s,3r,4s,5r,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}hexane-1,2,3,5,6-pentol
EN300-19737008

Research Excerpts

Overview

Lactitol is an effective drug in the treatment of chronic hepatic encephalopathy. Its mechanism of action involves not only a decrease of blood ammonium but also modifications of the degree of plasma amino acid imbalance.

ExcerptReferenceRelevance
"Lactitol is a synthetic sugar alcohol used as a sugar replacement in low calorie foods and selectively stimulating growth of L."( Proteome reference map of Lactobacillus acidophilus NCFM and quantitative proteomics towards understanding the prebiotic action of lactitol.
Ejby, M; Jacobsen, S; Jersie-Christensen, RR; Lahtinen, SJ; Majumder, A; Schmidt, BG; Sultan, A; Svensson, B, 2011
)
1.3
"Lactitol is a disaccharide analogue of lactulose which is available as a pure crystalline powder."( [A case of recurrent pneumatosis cystoides intestinalis associated with recurrent pneumoperitoneum].
Baik, HW; Hong, SK; Jang, EJ; Min, SY; Park, JS; Park, JY; Park, SJ; Yoon, JY, 2007
)
1.06
"Lactitol is an effective drug in the treatment of chronic hepatic encephalopathy; its mechanism of action involves not only a decrease of blood ammonium but also modifications of the degree of plasma amino acid imbalance, and fluid and circulatory adjustments."( Effects of lactitol [correction of lactilol] on hepatic encephalopathy and plasma amino-acid imbalance.
Carpinteri, G; Catalano, D; Mazzone, O; Runcio, N; Trovato, GM,
)
1.24
"Lactitol is a disaccharide analogue of lactulose which is available as a pure crystalline powder. "( Lactitol versus lactulose in the treatment of chronic hepatic encephalopathy. A double-blind, randomised, cross-over study.
Hawley, KE; Morgan, MY; Stambuk, D, 1987
)
3.16
"Lactitol is a disaccharide analogue of lactulose which can be produced as a pure crystalline powder with a low relative sweetness."( Lactitol in the treatment of chronic hepatic encephalopathy: an open comparison with lactulose.
Lanthier, PL; Morgan, MY, 1985
)
2.43

Effects

ExcerptReferenceRelevance
"Lactitol has been reported to decrease the blood ammonia concentration in various experimental hyperammonemia models such as portacaval shunted rats. "( Mechanism for lowering blood ammonia levels by lactitol.
Hirata, Y; Kimura, K; Niida, H; Ozaki, T; Ueda, F; Watanabe, M; Yamamoto, O; Yoshikuni, Y, 1995
)
1.99

Toxicity

Lactitol did not have any adverse effect on the postnatal development of the first (F1) generation offspring. Oral LD50 values of lactitol were estimated to be between 23 and 30 g/kg in male mice.

ExcerptReferenceRelevance
" Oral LD50 values of lactitol were estimated to be between 23 and 30 g/kg in male mice, approximately 30 g/kg in female mice, and more than 30 g/kg in male and female rats."( [Single dose toxicity studies of lactitol (NS-4) in mice and rats].
Hamasu, Y; Okazaki, S; Sumi, N; Suwa, K, 1994
)
0.89
" Nor did lactitol have any adverse effect on the postnatal development of the first (F1) generation offspring, such as differentiation, emotionality, motor ability, learning ability or reproductive performance."( [Reproductive and developmental toxicity studies of lactitol (NS-4) (2)--Teratogenicity study in rats by oral administration].
Ide, Y; Kishida, K; Kondo, J; Ninomiya, H; Nishikawa, K; Sumi, N; Watanabe, M; Yamashita, Y, 1994
)
0.96
" No adverse effects on litter parameters were recorded that could be attributed to treatment."( [Reproductive and developmental toxicity studies of lactitol (NS-4) (3)--Teratogenicity study in rabbits by oral administration].
Ross, FW; Sumi, N; Tesh, JM; Watanabe, M; Weith, A; Wightman, TJ; Wilby, OK, 1994
)
0.54
" Nor did lactitol have any adverse effect on the postnatal development of the first (F1) generation offspring, such as differentiation, emotionality, motor ability, learning ability or reproductive performance."( [Reproductive and developmental toxicity studies of lactitol (NS-4) (4)--Perinatal and postnatal study in rats by oral administration].
Ide, Y; Kishida, K; Kondo, J; Ninomiya, H; Nishikawa, K; Sumi, N; Watanabe, M; Yamashita, Y, 1994
)
0.96

Bioavailability

Lactulose and lactitol are poorly absorbed from the small intestine. Both are almost exclusively metabolized by the bacterial flora of the colon. Lactitol decreased the mean rate of absorption in healthy volunteers and patients with cirrhosis.

ExcerptReferenceRelevance
" The data indicate that lactitol was poorly absorbed from the gastrointestinal tract in healthy volunteers and patients with cirrhosis, and that the disaccharide did not disturb glucose or lactate homeostasis."( Lactitol: gastrointestinal absorption and effect on blood lactate in healthy volunteers and patients with cirrhosis.
Biollaz, J; Chollet, C; Lauterburg, BH; Llull, JB; Metzger, J; Wermeille, M, 1988
)
2.02
"Lactulose and lactitol, the synthetic compounds of lactose, are poorly absorbed from the small intestine, and both are almost exclusively metabolized by the bacterial flora of the colon."( [Lactulose and its derivatives--treatment of hepatic encephalopathy and other possible indications for its use].
Fehér, J; Prónai, L, 1993
)
0.65
" These results suggest that poorly absorbed fermentable dietary carbohydrate stimulates postprandial plasma enteroglucagon and inhibits serum gastrin release in the rat."( Fermentable carbohydrate modulates postprandial enteroglucagon and gastrin release in rats.
Gee, JM; Johnson, IT; Lee-Finglas, W, 1996
)
0.29
" These results appear reasonable, because xylitol is poorly absorbed from the small intestine, and the absorption rate is less than that of erythritol, while lactitol is not hydrolyzed."( Threshold for transitory diarrhea induced by ingestion of xylitol and lactitol in young male and female adults.
Nakamura, S; Oku, T, 2007
)
0.77
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51

Dosage Studied

The objective is to estimate the non-effective dosage that does not cause transitory diarrhea for xylitol, lactitol, and erythritol in healthy subjects. 25 cirrhotic patients with a history of repeated episodes of hepatic encephalopathy who required chronic administration of lactulose were included in a controlled cross-over clinical trial. The side effects which occurred during lactitol of the dosage, while those occurring during lactectar appeared when the dosage was higher than 40 g.

ExcerptRelevanceReference
" Clinical efficacy was found correct for 80 per cent of patients with a dosage of 20 g (single dose in the evening)."( [Lactitol in the treatment of constipation in the adult. Open, non-comparative study of its efficacy and its clinical and biological tolerance].
Delas, N; Gillaume, PN; Gislon, J; Glikmanas, M; Henri-Biabaud, E; Lemerez, M; Licht, H; Slama, JL, 1991
)
1.19
" lactulose in chronic recurrent portal-systemic encephalopathy (PSE), 25 cirrhotic patients with a history of repeated episodes of hepatic encephalopathy who required chronic administration of lactulose were included in a controlled cross-over clinical trial in which patients received, at random, lactitol (at an initial dosage of 10 g/6 h) or lactulose (15 ml/6 h, 66% w/v, containing 10 g of lactulose) during a 3 month period and then crossed-over to the alternative treatment for the following 3 months."( Lactitol vs. lactulose in the treatment of chronic recurrent portal-systemic encephalopathy.
Heredia, D; Orteu, N; Rodés, J; Terés, J, 1988
)
1.89
" In all cases the excessive flatulence occurred independently of sugar dosage whereas the development of diarrhoea was dose-related."( Lactitol versus lactulose in the treatment of chronic hepatic encephalopathy. A double-blind, randomised, cross-over study.
Hawley, KE; Morgan, MY; Stambuk, D, 1987
)
1.72
" Vomiting was seen within 30 minutes after dosing in all treated groups."( [Single dose toxicity study of lactitol (NS-4) in dogs].
Hamasu, Y; Nagata, R; Okasaki, K; Onishi, M; Sumi, N, 1994
)
0.57
" Only free sorbitol was detected in the gastrointestinal contents in both dosage groups."( Small intestinal transit and digestibility of lactitol in Wistar rats.
Grossklaus, R; Krüger, D; Soontornchai, S, 1998
)
0.56
" The first, the maximum permissive dosage of lactose not to induce transitory diarrhea was estimated based on the oral ingestion of lactose at several dose levels in all the subjects, and compared with that of lactitol which is not hydrolyzed by digestive enzymes."( Maximum permissive dosage of lactose and lactitol for transitory diarrhea, and utilizable capacity for lactose in Japanese female adults.
Ichinose, M; Nakamura, S; Oku, T, 2005
)
0.78
" The objective is to estimate the non-effective dosage that does not cause transitory diarrhea for xylitol, lactitol, and erythritol in healthy subjects."( Threshold for transitory diarrhea induced by ingestion of xylitol and lactitol in young male and female adults.
Nakamura, S; Oku, T, 2007
)
0.79
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Occurs in Manufacturing (33 Product(s))

Product Categories

Product CategoryProducts
Other17
Cibi e bevande a base vegetale, Cibi a base vegetale, Cereali e patate, Cereali e i loro prodotti, Pasta, Paste alimentari di cereali, Pasta secca, Pasta di grano duro1
Produits laitiers, Produits fermentés, Produits laitiers fermentés, Fromages, Fromages de vache, en:cooked-pressed-cheeses, Emmentals, Fromages de France, Emmentals français1
Plant-based foods and beverages, Dairy substitutes, Milk substitutes, Creamer1
Meats and their products,Meats,Poultries,Turkey and its products,Turkeys,Turkey thighs1
Aliments et boissons à base de végétaux, Aliments d'origine végétale, Aliments à base de fruits et de légumes, Desserts, Fruits et produits dérivés, Compotes, Compotes de poire1
Aliments et boissons à base de végétaux, Aliments d'origine végétale, Légumineuses et dérivés, Légumineuses, Graines, Graines de légumineuses, Plats préparés, Légumineuses sèches, Légumes préparés, Légumes cuits, Lentilles, Lentilles cuites1
Beverages, Alcoholic beverages, Beers, Ales, Dark ales, Porters1
Snacks, Sweet snacks, Biscuits and cakes, Biscuits1
Aliments et boissons à base de végétaux,Aliments d'origine végétale,Céréales et pommes de terre,Pains,Pains complets1
Aliments et boissons à base de végétaux,Aliments d'origine végétale,Céréales et pommes de terre,Graines,Céréales et dérivés,Céréales en grains,Riz1
Aliments et boissons à base de végétaux, Aliments d'origine végétale, Petit-déjeuners, Produits à tartiner, Pâtes à tartiner végétales, Produits à tartiner sucrés, Confitures et marmelades, Confitures, Confitures de cerises1
Viandes et dérivés, Plats préparés, Viandes, Plats préparés à la viande, Volailles, Canards, Plats à la volaille, Plats au canard, Confits de canard1
Energy drink with sugar,Energy drinks,Carbonated waters1
Petit-déjeuners, Produits à tartiner, Produits à tartiner sucrés, Produits de la ruche, Produits d'élevages, Édulcorants, Miels1
Cibi e bevande a base vegetale, Cibi a base vegetale, Colazioni, Cereali e patate, Cereali e i loro prodotti, Cereali da colazione, Fiocchi, Fiocchi di cereali, Fiocchi pressati, Fiocchi d'avena1
Növényi alapú élelmiszerek és italok, Növényialapú élelmiszerek, Gyümölcsök és zöldségek alapú élelmiszerek, Gyümölcs alapú élelmiszerek, Szárított termékek, Szárított növényi alapú ételek, Aszalt gyümölcsök1

Products

ProductBrandCategoryCompounds Matched from IngredientsDate Retrieved
Lactose free french vanilla coffee creamer ultra pasteurized, french vanillaPlant-based foods and beverages, Dairy substitutes, Milk substitutes, Creamertitanium dioxide2024-02-12
Sabor vainillaGamesaSnacks, Sweet snacks, Biscuits and cakes, Biscuitstocopherols2024-02-10
The Amber Edition: Strawberry ApricotRed BullEnergy drink with sugar,Energy drinks,Carbonated watersNiacinamide,Taurine,Caffeine,Calcium Pantothenate2024-04-02

Roles (3)

RoleDescription
laxativeAn agent that produces a soft formed stool, and relaxes and loosens the bowels, typically used over a protracted period, to relieve constipation. Compare with cathartic, which is a substance that accelerates defecation. A substances can be both a laxative and a cathartic.
excipientA generally pharmacologically inactive substance that is formulated with the active ingredient of a medication.
catharticAny substance that accelerates defecation. Compare with laxatives, which are substances that ease defecation (usually by softening faeces). A substance can be both a laxative and a cathartic.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (1)

ClassDescription
glycosyl alditol
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (5)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
AR proteinHomo sapiens (human)Potency8.76550.000221.22318,912.5098AID743036; AID743053
estrogen nuclear receptor alphaHomo sapiens (human)Potency2.53920.000229.305416,493.5996AID743075; AID743077; AID743079
Histone H2A.xCricetulus griseus (Chinese hamster)Potency55.19650.039147.5451146.8240AID1224845
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Bile salt export pumpHomo sapiens (human)IC50 (µMol)1,000.00000.11007.190310.0000AID1449628
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Other Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (22)

Processvia Protein(s)Taxonomy
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (8)

Processvia Protein(s)Taxonomy
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (12)

Processvia Protein(s)Taxonomy
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (35)

Assay IDTitleYearJournalArticle
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1449628Inhibition of human BSEP expressed in baculovirus transfected fall armyworm Sf21 cell membranes vesicles assessed as reduction in ATP-dependent [3H]-taurocholate transport into vesicles incubated for 5 mins by Topcount based rapid filtration method2012Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 40, Issue:12
Mitigating the inhibition of human bile salt export pump by drugs: opportunities provided by physicochemical property modulation, in silico modeling, and structural modification.
AID1420836Inhibition of recombinant HisA-tagged Trypanosoma cruzi trans-sialidase expressed in Escherichia coli BL21 (DE3) using 3-sialyl-lactose as donor measured after 15 mins by HPAEC-PAD2018European journal of medicinal chemistry, Oct-05, Volume: 158The synthesis and kinetic evaluation of aryl α-aminophosphonates as novel inhibitors of T. cruzi trans-sialidase.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (184)

TimeframeStudies, This Drug (%)All Drugs %
pre-199032 (17.39)18.7374
1990's67 (36.41)18.2507
2000's40 (21.74)29.6817
2010's33 (17.93)24.3611
2020's12 (6.52)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 67.57

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index67.57 (24.57)
Research Supply Index5.51 (2.92)
Research Growth Index4.65 (4.65)
Search Engine Demand Index117.46 (26.88)
Search Engine Supply Index2.03 (0.95)

This Compound (67.57)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials48 (24.37%)5.53%
Reviews22 (11.17%)6.00%
Case Studies3 (1.52%)4.05%
Observational0 (0.00%)0.25%
Other124 (62.94%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (20)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Immune Response After Vaccination Against Pandemic A/H1N1 Influenza in the Immunocompromised Host. Vaccination Response in ImmunoCompromised Host [NCT01066169]104 participants (Actual)Observational2009-11-30Completed
Phase III, Stratified, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Doses of aH5N1 When Administered to Adult and Elderly Subjects With and Without Underlying Medical Conditions. [NCT02091908]Phase 3540 participants (Actual)Interventional2014-04-30Completed
Investigating Meningococcal Vaccines in Adults - An Exploratory, Open-label, Immunogenicity Study of a Licensed Meningococcal Capsular Group B Vaccine (4CMenB, Bexsero®) in Adults [NCT02398396]15 participants (Actual)Interventional2015-04-30Completed
Development of Fecal Scoring for the Management of Fecal Impaction With Regards to Lower Urinary Tract Dysfunction [NCT04579731]187 participants (Actual)Observational2020-08-25Completed
A Phase 2b, Open-Label, Multi-Center Study to Evaluate the Persistence of Antibody Response and to Assess the Immune Response to a Booster Dose of MenACWY Conjugate Vaccine in Subjects Previously Vaccinated as Adolescents With Either MenACWY Conjugate Vac [NCT01018732]Phase 2155 participants (Actual)Interventional2010-01-31Completed
A Phase III, Stratified, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Doses of aH5N1when Administered to Adult and Elderly Subjects With and Without Immunosuppressive Conditions [NCT02107807]Phase 3539 participants (Actual)Interventional2014-04-30Completed
Double-blind, Placebo-controlled, Randomized Study: Oxytocin Modulation of Stress-Associated Chemosignals Processing [NCT03265899]Phase 160 participants (Actual)Interventional2015-07-01Completed
Evaluation of p53peptide-pulsed Dendritic Cells in Combination With an Aromatase Inhibitor as a Treatment for Patients With Breast Cancer With Disease Recurrence After Adjuvant or First Line Endocrine Therapy. [NCT00935558]Phase 20 participants (Actual)Interventional2009-07-31Withdrawn(stopped due to no patients enrolled)
Evaluation of Novartis Access; a Non-communicable Disease (NCD) Access Initiative [NCT02773095]966 participants (Actual)Interventional2016-06-30Completed
A Phase 3, Single-Center, Open-label, Controlled, Randomized Study to Evaluate the Safety and Immunogenicity of Novartis Men ACWY Vaccine Administered Either Alone or Concomitantly With a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Va [NCT00518180]Phase 31,620 participants (Actual)Interventional2007-07-31Completed
A 3-Week, Single-Blind, Placebo-Controlled, Within-Patient, Randomized Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children [NCT00810862]Phase 418 participants (Actual)Interventional2006-11-30Terminated(stopped due to Lack of subject enrollment over the past two years.)
Retinal Optical Coherence Tomography and Multifocal Electroretinogram; Establishing Normal Ranges Related to Age and Reproductive Factors; With the Use of Anti-inflammatory Medications;In Uncomplicated Anterior Uveitis; Anatomy and Function. [NCT00476593]218 participants (Actual)Interventional2005-09-30Completed
Different Induction Protocols in PCOS After Clomiphene Citrate Failed Pregnancy in Non-IVF Cycles [NCT05362799]Phase 4176 participants (Anticipated)Interventional2022-06-01Not yet recruiting
Immunosuppression in Renal Transplantation in The Elderly: Time to Rethink. - nEverOld Study [NCT01631058]Phase 490 participants (Anticipated)Interventional2012-07-31Recruiting
A Multicenter, Single Arm, Post Marketing Surveillance Study to Monitor the Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) Administered According to the Prescribing Information to Healthy Subjects 2 Years of Age and Older in the Phi [NCT01705379]0 participants (Actual)Observational2013-03-31Withdrawn
Clinical and Economic Burden of Uncontrolled Epilepsy: Analyses From a Medicaid Database and a Private Health Plan Database [NCT01390909]12,386 participants (Actual)Observational2010-05-31Completed
A Single Centre, Open-label, Randomised Clinical Study to Investigate Meningococcal Serogroup A and C Saccharide Specific B Cell Responses in Adult Volunteers to One of Three Regimens of Meningococcal ACWY Conjugate Vaccine or Meningococcal ACWY Polysacch [NCT01593514]Phase 420 participants (Actual)Interventional2012-12-31Completed
A Phase 3, Multi-center, Observer-blind, Placebo-controlled, Randomized Study to Evaluate the Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 11 to 55 Years of Age in Korea [NCT01274897]Phase 3450 participants (Actual)Interventional2010-12-31Completed
Intestinal Permeability in Obesity of Intercellular Tight Junctions to Metabolic Complications [NCT02292121]80 participants (Actual)Interventional2014-02-24Terminated(stopped due to lack of surgical controls)
Pilot Study of the Effectiveness of Probiotics and Lactitol for the Intestinal Decolonization of People Carriers of Klebsiella Pneumoniae Producers of Carbapenemase OXA-48-type: DesProbiOXA Study [NCT02307383]Phase 220 participants (Anticipated)Interventional2014-10-31Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00476593 (1) [back to overview]Macular Thickness Measured With the OCT; in Relation to Age, Sex, Reproductive Factors and the Use of Anti-inflammatory Eye Drops in Health; in Uncomplicated Anterior Uveitis.
NCT00518180 (13) [back to overview]Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups
NCT00518180 (13) [back to overview]Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus
NCT00518180 (13) [back to overview]Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN)
NCT00518180 (13) [back to overview]Geometric Mean Titers (GMT) of Pertussis Antigens
NCT00518180 (13) [back to overview]Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay
NCT00518180 (13) [back to overview]Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
NCT00518180 (13) [back to overview]Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
NCT00518180 (13) [back to overview]Percentage of Subjects With Anti-HPV Seroconversion
NCT00518180 (13) [back to overview]Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL
NCT00518180 (13) [back to overview]Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups
NCT00518180 (13) [back to overview]Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse
NCT00518180 (13) [back to overview]Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN
NCT00518180 (13) [back to overview]The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus
NCT01018732 (9) [back to overview]Geometric Mean Ratio After Booster Vaccination
NCT01018732 (9) [back to overview]Geometric Mean Titer After Booster Vaccination
NCT01018732 (9) [back to overview]Geometric Mean Titer at 5 Years After Primary Vaccination
NCT01018732 (9) [back to overview]Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination
NCT01018732 (9) [back to overview]Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination
NCT01018732 (9) [back to overview]Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination
NCT01018732 (9) [back to overview]Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination
NCT01018732 (9) [back to overview]Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination
NCT01018732 (9) [back to overview]Percentage of Subjects With hSBA Seroresponse After Booster Vaccination
NCT01274897 (4) [back to overview]Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.
NCT01274897 (4) [back to overview]Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination
NCT01274897 (4) [back to overview]Percentages of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.
NCT01274897 (4) [back to overview]Percentages of Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.
NCT01390909 (1) [back to overview]Average Annualized Costs

Macular Thickness Measured With the OCT; in Relation to Age, Sex, Reproductive Factors and the Use of Anti-inflammatory Eye Drops in Health; in Uncomplicated Anterior Uveitis.

Macular thickness was assessed with the OCT in healthy subjects and in patients with anterior uveitis. Data was analyzed with respect to age, sex, parity, the use of hormonal therapy, after treatment with to types of anti-inflammatory eye drops, and in uncomplicated uveitis. (NCT00476593)
Timeframe: Macular thickness measured with the OCT

InterventionMacular Thickness in micron (Mean)
A Diclofenac268
B Dexamethasone272
Patients With Anterior Uveitis276
Healthy Volunteers267

[back to top]

Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups

The immune responses to the MenACWY conjugate vaccine, as measured by the hSBA Geometric Mean Titers (GMTs) when given: (a) alone, (b) concomitantly with the Tdap vaccine and the HPV vaccine, and (c) when given one month after the Tdap vaccine. (NCT00518180)
Timeframe: 1 month post MenACWY vaccination

,,
InterventionTiters (Geometric Mean)
Serogroup A (N=494, 486, 458)Serogroup C (N=476, 472, 457)Serogroup W (N=487, 474, 458)Serogroup Y (N=493, 487, 460)
MenACWY→Tdap→HPV677015981
MenACWY+Tdap+HPV626614672
Tdap → MenACWY→HPV956810457

[back to top]

Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus

To compare the immune response of Tdap, as measured by the antidiphtheria and antitetanus GMCs, when administered one month after the MenACWY vaccine with the immune response of the Tdap vaccine when administered alone. (NCT00518180)
Timeframe: 1 month post Tdap vaccination

,,
InterventionIU/mL (Geometric Mean)
DiphtheriaTetanus
MenACWY→Tdap→HPV1012
MenACWY+Tdap+HPV378.75
Tdap → MenACWY→HPV1010

[back to top]

Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN)

To compare the immune response of Tdap given concomitantly with MenACWY and HPV vaccine with the immune response of Tdap when administered alone (NCT00518180)
Timeframe: 1 month post Tdap vaccination

,,
InterventionIU/mL (Geometric Mean)
Anti-PT (N=479, 451, 477)Anti-FHA (N=489, 457, 485)Anti-PRN (N=492, 458, 487)
MenACWY→Tdap→HPV7911061563
MenACWY+Tdap+HPV51342819
Tdap →MenACWY → HPV635111197

[back to top]

Geometric Mean Titers (GMT) of Pertussis Antigens

To compare the immune response to Tdap administered one month after MenACWY with the immune response to Tdap administered alone. (NCT00518180)
Timeframe: 1 month post Tdap vaccination

,,
InterventionTiters (Geometric Mean)
Anti-PT (N=479, 451, 477)Anti-FHA (N=489, 457, 485)Anti-PRN (N=492, 458, 487)
MenACWY→Tdap→HPV7911061563
MenACWY+Tdap+HPV51342819
Tdap → MenACWY→HPV635111197

[back to top]

Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay

To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccine vaccination.) (NCT00518180)
Timeframe: 1 month post third HPV vaccination

,
InterventionTiters (Geometric Mean)
HPV 6 (N=361, 737)HPV 11 (N=362, 744)HPV 16 (N=360, 744)HPV 18 (N=364, 743)
HPV Alone1461170165901117
MenACWY+Tdap+HPV105912645286908

[back to top]

Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination

Number of subjects with specified local and systemic reactions were solicited for 7 days after the HPV vaccination. (NCT00518180)
Timeframe: Days 1 to 7

,,
InterventionSubjects (Number)
Injection site pain postvaccination 1Injection site erythema postvaccination 1Injection site induration postvaccination 1Injection site pain (N=498, 483, 468) postvac 2Injection site erythema postvaccination 2Injection site induration postvaccination 2Injection site pain postvaccination 3Injection site erythema postvaccination 3Injection site induration postvaccination 3Chills postvaccination 1Nausea postvaccination 1Malaise postvaccination 1Myalgia postvaccination 1Arthralgia postvaccination 1Headache postvaccination 1Rash postvaccination 1Fever (≥ 38°C) postvaccination 1Stayed home postvaccination 1Chills postvaccination 2Nausea postvaccination 2Malaise postvaccination 2Myalgia postvaccination 2Arthralgia postvaccination 2Headache postvaccination 2Rash postvaccination 2Fever (≥ 38°C) postvaccination 2Chills postvaccination 3Nausea postvaccination 3Malaise postvaccination 3Myalgia postvaccination 3Arthralgia postvaccination 3Headache postvaccination 3Rash postvaccination 3Fever (≥ 38°C) postvaccination 3
MenACWY→Tdap→HPV180362720848372275647273949323393721262230453828781122243550492685716
MenACWY+Tdap+HPV2657454208624622960607788133146942172127110233853423088417223249533779920
Tdap → MenACWY → HPV204422618957502085548303255562897623342629345121719222534413730791025

[back to top]

Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.

Number of subjects with specified local and systemic reactions were assessed when MenACWY was given alone, one month after Tdap, and concomitantly with Tdap and HPV vaccine. (NCT00518180)
Timeframe: Days 1 to 7

,,
InterventionSubjects (Number)
Injection site pain MenACWYInjection site pain TdapInjection site erythema MenACWYInjection site erythema TdapInjection site induration MenACWYInjection site induration TdapChills post-vaccination 1Chills post-vaccination 2Nausea post-vaccination 1Nausea post-vaccination 2Malaise post-vaccination 1Malaise post-vaccination 2Myalgia post-vaccination 1Myalgia post-vaccination 2Arthralgia post-vaccination 1Arthralgia post-vaccination 2Headache post-vaccination 1Headache post-vaccination 2Rash post-vaccination 1Rash post-vaccination 2Fever ≥ 38°Celsius post-vaccination 1Fever ≥ 38°Celsius post-vaccination 2Analgesic/Antipyretic Med. Used post-vaccination 1Analgesic/Antipyretic Med. Used post-vaccination 2
MenACWY→Tdap → HPV246310663870646642724211091104816252194125171519258358
MenACWY+Tdap+HPV263367687868907708801330146094021702102701100
Tdap → MenACWY →HPV2393836470631107045826411588142827652200138201317309649

[back to top]

Percentage of Subjects With Anti-HPV Seroconversion

To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccination.) Anti-HPV Seroconversion (SC): SC was defined as negative (baseline HPV titer < type-specific cut-off) for anti-HPV and anti-HPV ≥ an HPV type-specific cut-off at one month after the third HPV injection. (NCT00518180)
Timeframe: 1 month post third HPV vaccination

,
InterventionPercentage of subjects (Number)
HPV 6 (N=361, 737)HPV 11 (N=362, 744)HPV 16 (N=360, 744)HPV 18 (N=364, 743)
HPV Alone10010010099
MenACWY+Tdap+HPV99100100100

[back to top]

Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL

To compare the immune response to Tdap given concomitantly with MenACWY and HPV vaccine with the immune response to Tdap when administered alone (NCT00518180)
Timeframe: 1 month post Tdap vaccination

,,
InterventionPercentage of subjects (Number)
DiphtheriaTetanus
MenACWY→Tdap→HPV100100
MenACWY+Tdap+HPV100100
Tdap →MenACWY → HPV98100

[back to top]

Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups

The immune responses to MenACWY, as measured by the percentage of subjects with hSBA titer ≥ 1:8, hSBA titer ≥ 1:4, when given: (a) alone, (b) concomitantly with Tdap and HPV vaccine; and (c) when given one month after Tdap. (NCT00518180)
Timeframe: 1 month post MenACWY vaccination

,,
InterventionPercentage of subjects (Number)
Serogroup A hSBA ≥ 1:8 (N=494, 486, 458)Serogroup C hSBA ≥ 1:8 (N=476, 472, 457)Serogroup W hSBA ≥ 1:8 (N=487, 474, 458)Serogroup Y hSBA ≥ 1:8 (N=493, 487, 460)Serogroup A hSBA ≥ 1:4 (N=408, 404, 412)Serogroup C hSBA ≥ 1:4 (N=456, 447, 430)Serogroup W hSBA ≥ 1:4 (N=478, 471, 443)Serogroup Y hSBA ≥ 1:4 (N=465, 456, 438)
MenACWY→Tdap→HPV8290999383929994
MenACWY+Tdap+HPV8192989383929894
Tdap → MenACWY→HPV8993959290949795

[back to top]

Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse

"Immune responses to MenACWY, as measured by the percentage of hSBA seroresponders, when given: (a) alone; (b) concomitantly with a Tetanus diphtheria acellular pertussis (Tdap) vaccine and a Human Papillomavirus Recombinant (HPV) vaccine; and (c) when given one month after a Tdap vaccine.~Seroresponse to MenACWY: For a subject with baseline hSBA titer <1:4, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline." (NCT00518180)
Timeframe: 1 month post MenACWY vaccination

,,
InterventionPercentage of participants (Number)
Serogroup A (N=494, 486, 458)Serogroup C (N=476, 472, 457)Serogroup W (N=487, 474, 458)Serogroup Y (N=493, 487, 460)
MenACWY→Tdap→HPV82848182
MenACWY+Tdap+HPV80837783
Tdap →MenACWY → HPV87846578

[back to top]

Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN

To compare the immune response of Tdap, defined by the percentage of subjects with a 4-fold rise in antibody titer over baseline against PT, FHA, PRN, when administered one month after the MenACWY with the immune response of Tdap when administered alone. (NCT00518180)
Timeframe: 1 month post Tdap vaccination

,,
InterventionPercentages of subjects (Number)
Anti-PT (N=479, 451, 477)Anti-FHA (N=489, 457, 485)Anti-PRN (N=492, 458, 487)
MenACWY→Tdap→HPV899095
MenACWY+Tdap+HPV836786
Tdap → MenACWY→HPV867889

[back to top]

The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus

The immune response to the Tdap vaccine, as measured by the percentage of subjects with antidiphtheria and antitetanus toxin ≥1.0 IU/mL. (NCT00518180)
Timeframe: 1 month post Tdap vaccination

,,
InterventionPercentages of subjects (Number)
Diphtheria (% ≥1.0 IU/mL)Tetanus (% ≥1.0 IU/mL)
MenACWY→Tdap→HPV100100
MenACWY+Tdap+HPV100100
Tdap → MenACWY→HPV98100

[back to top]

Geometric Mean Ratio After Booster Vaccination

Ratios are expressed as geometric mean titer at Day 8: Day 1 and at Day 29:Day 1 (NCT01018732)
Timeframe: Day 8 and Day 29 (at 5 Years After Primary Vaccination)

,,
InterventionGeometric mean ratio (Mean)
Men A (Day 8:1)Men A (Day 29:1), N=48, N=49, N=50Men C (Day 8:1)Men C (Day 29:1)Men W-135 (Day 8:1)Men W-135 (Day 29:1)Men Y (Day 8:1), N=48, N=49, N=50Men Y (Day 29:1)
I:MenACWY205155786058569674
II:Licensed Polysacharide Meningococcal Vaccine6.1201.852.642.924.062.698.12
III: Meningococcal-naive11379.48175.957.487.2913

[back to top]

Geometric Mean Titer After Booster Vaccination

Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) and reported as hSBA Geometric mean titer (GMT) in previously vaccinated subjects and in age-matched meningococcal vaccine-naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y (NCT01018732)
Timeframe: Day 8, Day 29 (5 years after primary vaccination)

,,
InterventionTiter (Geometric Mean)
Baseline, Men ADay 8, Men A,Day 29, Men A, (N=48, G I)Baseline, Men CDay 8, Men CDay 29, Men CBaseline, Men W-135Day 8, Men W-135Day 29, Men W-135Baseline, Men YDay 8, Men Y, (N=48, GI)Day 29, Men Y
I:MenACWY5.161059819201603121729168516442825612092
II:Licensed Polysacharide Meningococcal Vaccine7.31451471936511234477.82163
III: Meningococcal-naive3.06341137.34701271163798.6964110

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Geometric Mean Titer at 5 Years After Primary Vaccination

Persistence was measured by serum bactericidal assay with human complement(hSBA) and expressed as hSBA GMT in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y (NCT01018732)
Timeframe: Day 1 (5 years after primary vaccination )

,,
InterventionTiter (Geometric Mean)
Men AMen CMen W-135Men Y
I:MenACWY5.21202827
II:Licensed Polysacharide Meningococcal Vaccine7.5619127.67
III: Meningococcal-naive37.62119.38

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Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination

Local and systemic reactions were solicited to assess safety and tolerability of vaccination (NCT01018732)
Timeframe: Up to Day 7

,,
Interventionparticipants (Number)
Local Reactions (any-total)Pain (any)Erythema (any)Induration (any)Sytemic Reactions (any-total)Chills (any)Nausea (any)Malaise (any)Myalgia (any)Arthalgia (any)Headache (any)Fever >= 38CStayed at homeAnalgesic antipyretic medication used
I:MenACWY302985317810163210010
II:Licensed Polysacharide Meningococcal Vaccine32278825591113517028
III: Meningococcal-naive4033155383111517631129

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Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination

Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) >= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y. (NCT01018732)
Timeframe: Day 7, Day 28 post booster (5 years after primary vaccination)

,,
InterventionPercentage of participants (Number)
Day 7 post booster, Men ADay 28 post booster, Men ADay 7 post booster, Men CDay 28 post booster, Men CDay 7 post booster, Men W-135Day 28 post booster, Men W-135Day 7 post booster, Men YDay 28 post booster, Men Y
I:MenACWY1009810010010010098100
II:Licensed Polysacharide Meningococcal Vaccine76948290869478100
III: Meningococcal-naive66929498929492100

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Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination

Persistence was measured by percentage of subjects with serum bactericidal activity with human complement (hSBA) >= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y (NCT01018732)
Timeframe: Day 1 (5 years after primary vaccination )

,,
InterventionPercentage of participants (Number)
Men AMen CMen W-135Men Y
I:MenACWY34848076
II:Licensed Polysacharide Meningococcal Vaccine50685860
III: Meningococcal-naive23705560

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Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination

Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) >= 8 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y. (NCT01018732)
Timeframe: Day 7, Day 28 post booster (5 years after primary vaccination)

,,
InterventionPercentage of participants (Number)
Day 7 post booster, Men ADay 28 post booster, Men ADay 7 post booster, Men CDay 28 post booster, Men CDay 7 post booster, Men W-135Day 28 post booster, Men W-135Day 7 post booster, Men YDay 28 post booster, Men Y
I:MenACWY1009810010010010098100
II:Licensed Polysacharide Meningococcal Vaccine7394788484927696
III: Meningococcal-naive6492909888949098

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Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination

Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) >= 8 [i.e. percentage of subjects with hsBA titer >=8] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y (NCT01018732)
Timeframe: Day 1 (5 years after primary vaccination)

,,
InterventionPercentage of participants (Number)
Men AMen CMen W-135Men Y
I:MenACWY30767276
II:Licensed Polysacharide Meningococcal Vaccine44625650
III: Meningococcal-naive11515155

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Percentage of Subjects With hSBA Seroresponse After Booster Vaccination

For a subject with hSBA titer <4 at baseline, seroresponse is defined as a postvaccination hSBA titer >=8; and for a subject with hSBA titer >=4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y. (NCT01018732)
Timeframe: Day 8, Day 29 (5 years after primary vaccination)

,,
InterventionPercentage of participants (Number)
Men A, Day 8Men A, Day 29Men C, Day 8Men C, Day 29Men W-135, Day 8Men W-135, Day 29Men Y, Day 8, (N=48, G I)Men Y, Day 29
I:MenACWY100100969696989494
II:Licensed Polysacharide Meningococcal Vaccine5176163137473355
III: Meningococcal-naive6090628048585476

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Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.

Immunogenicity was assessed as hSBA GMTs and associated 95% CI, measured against N. meningitidis serogroups A, C, W and Y, before the vaccination (baseline, day 1) and at day 29 (28 days after MenACWY-CRM vaccination). (NCT01274897)
Timeframe: day 1 and day 29

,
InterventionTiters (Geometric Mean)
Serogroup A at Day 1 (N=295,152)Serogroup A at Day 29 (N=295,152)Serogroup C at Day 1 (N=293,150)Serogroup C at Day 29 (N=293,150)Serogroup W at Day 1 (N=293,151)Serogroup W at Day 29 (N=293,151)Serogroup Y at Day 1 (N=294,152)Serogroup Y at Day 29 (N=294,152)
MenACWY-CRM2.7487.82231511479.01107
Placebo2.8635.946.0448478.828.4

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Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination

(NCT01274897)
Timeframe: during 7 days of vaccination

,
InterventionSubjects (Number)
Injection site painInjection site erythemaInjection site indurationChillsNauseaMyalgiaArthralgiaHeadacheRashFever (≥38°C)Axillary temperature (<38.0°C)Stayed homeUsed analgesic or antipyretic medicines
MenACWY-CRM6930301722456391329497
Placebo1230710134250115223

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Percentages of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.

Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI, at baseline before vaccination (day 1) and at day 29 (28 days after MenACWY-CRM vaccination). (NCT01274897)
Timeframe: day 1 and day 29

,
InterventionPercentages of subjects (Number)
Serogroup A at Day 1 (N=295,152)Serogroup A at Day 29 (N=295,152)Serogroup C at Day 1 (N=293,150)Serogroup C at Day 29 (N=293,150)Serogroup W at Day 1 (N=293,151)Serogroup W at Day 29 (N=293,151)Serogroup Y at Day 1 (N=294,152)Serogroup Y at Day 29 (N=294,152)
MenACWY-CRM1379499989985494
Placebo1516393787885351

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Percentages of Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.

"Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y by serum bactericidal assay using human complement, human serum bactericidal assay (hSBA), at day 29 (28 days after MenACWY-CRM vaccination).~Seroresponse is defined as:~for subjects with a pre-vaccination hSBA titer < 1:4, a postvaccination hSBA titer ≥ 1:8.~for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer." (NCT01274897)
Timeframe: day 29

,
InterventionPercentages of subjects (Number)
Serogroup A (N=295,152)Serogroup C (N=293,150)Serogroup W (N=293,151)Serogroup Y (N=294,152)
MenACWY-CRM76862869
Placebo1142

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Average Annualized Costs

Average annualized overall healthcare costs and epilepsy-related healthcare costs were calculated for each treatment group. Epilepsy-related costs were those with a code for epilepsy. ED, Emergency Department; AMC, All Medical Costs; Ep Rel, Epilepsy Related. United States dollars were consumer price index adjusted for 2009. (NCT01390909)
Timeframe: 1 year

,,,,,,,
InterventionUnited States dollars (Mean)
AEDsNon-AEDsHospitalizations; AMCED Visits; AMCOutpatient Visits; AMCNeurology Visits; AMCOther Healthcare Services; AMCHospitalizations; Ep RelED Visits; Ep RelOutpatient Visits; Ep RelNeurology Visits; Ep RelOther Healthcare Costs; Ep RelTotal Healthcare Costs; AMC
Medicaid, Intermediate1050480135132421804522342817024624833127334839
Medicaid, Uncontrolled13575725704142124668622113413511146959147539123
Medicaid, Uncontrolled, Subgroup13525615690240024168622022410210946760150238708
Medicaid, Well Controlled46236579589712582123202NANA68975429635
Private, Intermediate12993883585825457804426452413394791654217719
Private, Uncontrolled171345871235760357715661026764615370223710226057
Private, Uncontrolled, Subgroup169744971130858657575561008670015270323510324853
Private, Well Controlled63930961697763061175436NANA17968179005

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