Page last updated: 2024-12-06

aluminum phosphate

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

Aluminum phosphate is a white, odorless, and tasteless inorganic compound with the chemical formula AlPO4. It is a naturally occurring mineral known as variscite. Aluminum phosphate is a versatile compound with a wide range of applications, including as a fire retardant, a catalyst, a filler in plastics and paints, and an adsorbent. It is often used in the synthesis of other aluminum-containing compounds. Aluminum phosphate is also studied for its potential use in various fields, such as medicine, agriculture, and environmental remediation. Its importance lies in its unique properties, such as its thermal stability, its ability to absorb water, and its catalytic activity.'

aluminum phosphate: gel used as immunologic adjuvent; RN given refers to Al salt [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID64655
CHEMBL ID3833315
MeSH IDM0059957

Synonyms (56)

Synonym
aluminum phosphate (usp)
D02862
7784-30-7
phosphaljel (tn)
aluminum acid phosphate
aluminiumphosphat [german]
phosphaljel
aluphos
aluminium orthophosphate, natural
phosphoric acid, aluminum salt (1:1)
aluminum phosphate (1:1)
aluminophosphoric acid
aluminum phosphate
aluminum monophosphate
einecs 232-056-9
ffb 32
monoaluminum phosphate
phosphalugel
aluminum phosphoric acid
aluminum dihydrogen phosphate
unii-f92v3s521o
f92v3s521o ,
aluminum phosphate [usp]
aluminiumphosphat
aluminium orthophosphate
ec 232-056-9
FT-0622223
aluminium phosphate
aluminium phosphate gel [ep monograph]
aluminum phosphate gel
aluminum phosphate [mi]
aluminum phosphate [vandf]
aluminium phosphate (1:1)
aluminium phosphate [who-dd]
aluminum phosphate [usp impurity]
aluminium phosphate gel
aluminium phosphate [mart.]
phosphoric acid, aluminium salt (1:1)
AKOS015856690
ILRRQNADMUWWFW-UHFFFAOYSA-K
DTXSID5064839 ,
98499-64-0
aluminumphosphate
mfcd00003430
aluminum phosphate, puratronic
CHEMBL3833315
56574-68-6
phosphoric acid, aluminum salt, basic
DB14517
aluminum monophosphate; aluminum orthophosphate;phosphalutab; phosphaluvet; rehydraphos
alo4p
aluminium phosphate (mart.)
aluminum phosphate (usp impurity)
aluminium phosphoricum
dtxcid6048042
aluminium phosphate gel (ep monograph)

Research Excerpts

Treatment

ExcerptReferenceRelevance
"Upon treatment with aluminum phosphate, however, these protein levels were restored to normal gradually over 30-60 d in rats with acid RE (30.4% +/- 2.1% vs 20.5% +/- 2.1%, P > 0.05, treated vs untreated, respectively)."( Interleukin-6, desmosome and tight junction protein expression levels in reflux esophagitis-affected mucosa.
Li, FY; Li, Y, 2009
)
0.67

Toxicity

ExcerptReferenceRelevance
" From the 2nd day to the next immunization only data about adverse events necessitating a physician's visit or about serious adverse events were collected."( Safety, tolerability and immunogenicity of a Haemophilus influenzae type b vaccine containing aluminum phosphate adjuvant administered at 2, 3 and 4 months of age.
Baldini, A; Ceyhan, M; Kanra, G; Kara, A; Mutlu, B; Ozmert, E; Podda, A; Viviani, S; Yalçin, S; Yurdakök, K,
)
0.35
" Nine serious adverse events were reported in seven cases of which none were related to vaccines."( Effect of aluminum adjuvants on safety and immunogenicity of Haemophilus influenzae type b-CRM197 conjugate vaccine.
Anemona, A; Baldini, A; Bilgili, N; Cengiz, AB; Demiralp, O; Kanra, G; Kara, A; Marchetti, E; Mutlu, B; Ozmert, E; Podda, A; Viviani, S; Yalçin, S; Yurdakök, K, 2003
)
0.32
" We conducted a phase II trial of the Bot F vaccine over 3 years in 144 healthy adult volunteers to identify one of three vaccination schedules that was safe and maximally immunogenic for adult volunteers."( Phase II safety and immunogenicity study of type F botulinum toxoid in adult volunteers.
Bodison, SA; DeTolla, LJ; Edelman, R; O'Donnoghue, M; Perry, JG; Wasserman, SS, 2003
)
0.32
" In conclusion, the EBA-175 vaccine with adjuvant was safe and immunogenic in malaria-naïve subjects."( Safety and immunogenicity of a recombinant nonglycosylated erythrocyte binding antigen 175 Region II malaria vaccine in healthy adults living in an area where malaria is not endemic.
Atmar, RL; Dube, T; El Sahly, HM; Keitel, WA; Lanford, TA; Long, C; Patel, SM; Sim, BK; Thompson, D, 2010
)
0.36
"The RSV F nanoparticle vaccine candidate was well tolerated without dose-related increases in adverse events."( Safety and immunogenicity of a Sf9 insect cell-derived respiratory syncytial virus fusion protein nanoparticle vaccine.
Boddapati, S; Fries, L; Glenn, GM; Hickman, SP; Kpamegan, E; Lu, H; Piedra, PA; Raghunandan, R; Smith, G; Thomas, DN; Zhou, B, 2013
)
0.39
" No serious adverse events were detected and the vaccine was well tolerated by both age groups."( A Reduced Dose Whole Virion Aluminum Adjuvanted Seasonal Influenza Vaccine Is Immunogenic, Safe, and Well Tolerated in Pediatric Patients.
Balaton, G; Torzsa, P; Vajo, P; Vajo, Z, 2021
)
0.62

Compound-Compound Interactions

ExcerptReferenceRelevance
" Subjects were studied after an initial dose given without gastric protection, after ingestion of a single dose given with aluminum phosphate and, lastly, after four days of continuous treatment with this product."( [The bioavailability of ketoprofen (Profenid) administered orally in combination with a gastric protector (aluminum phosphate, Phosphalugel)].
Ambert, D; Bannier, A; Brazier, JL; Tamisier, JN, 1983
)
0.69

Bioavailability

The effect of aluminum phosphate on the bioavailability of ranitidine has been investigated in 10 young, healthy volunteers. Results of plasma peak level and its time of occurrence, area under the curve, half-life and elimination constant establish that ketoprofen is not changed by association with aluminum phosphate.

ExcerptReferenceRelevance
" Al bioavailability depends on the solubility of the salt ingested as well as on the physicochemical properties of the Al soluble complexes formed in the gi fluid."( Why aluminum phosphate is less toxic than aluminum hydroxide.
Berthon, G; Daydé, S, 1992
)
0.84
"The effect of aluminum phosphate on the bioavailability of ranitidine has been investigated in 10 young, healthy volunteers."( Effect of aluminum phosphate on the bioavailability of ranitidine.
Albin, H; Begaud, B; Bistue, C; Perez, P; Vinçon, G, 1987
)
1.04
" Results of plasma peak level and its time of occurrence, area under the curve, half-life and elimination constant establish that bioavailability of ketoprofen is not changed by association with aluminum phosphate."( [The bioavailability of ketoprofen (Profenid) administered orally in combination with a gastric protector (aluminum phosphate, Phosphalugel)].
Ambert, D; Bannier, A; Brazier, JL; Tamisier, JN, 1983
)
0.67
" During the absorption phase isofezolac plasma levels were slightly decreased in association with isofezolac-aspirin, but bioavailability of isofezolac was not modified."( The effect of antacid and aspirin on the bioavailability of isofezolac in man.
Flouvat, B; Henry, JF; Rocher, I, 1984
)
0.27
" The results indicate that aluminium phosphate does not reduce the bioavailability of cimetidine and prednisolone."( Effect of aluminium phosphate on the bioavailability of cimetidine and prednisolone.
Albin, H; Bedjaoui, A; Begaud, B; Demotes-Mainard, F; Vincon, G, 1984
)
0.27
"The purpose of this study was to determine whether a concomitant single dose of antacid (aluminium phosphate), or multiple doses of this antacid, administered prior to and with ketoprofen would alter the bioavailability of this non steroidal anti-inflammatory agent."( Bioavailability of ketoprofen in man with and without concomitant administration of aluminium phosphate.
Ambert, D; Bannier, A; Brazier, JL; Tamisier, JN, 1981
)
0.26
" Transformation from non-apatite inorganic phosphorus (NAIP) to apatite phosphorus (AP), which has a higher bioavailability and more extensive industrial applications, was studied at 750-950°C by sewage sludge incineration and model compound incineration with a calcium oxide (CaO) additive."( Transformation of apatite phosphorus and non-apatite inorganic phosphorus during incineration of sewage sludge.
Li, R; Li, Y; Teng, W; Wang, W; Yang, T; Zhang, Z, 2015
)
0.42

Dosage Studied

ExcerptRelevanceReference
" The transesterification was optimal at 453 K for 5h with a methanol/oil ratio of 30:1 and catalyst dosage of 5 wt."( Transesterification of soybean oil over WO3 supported on AlPO4 as a solid acid catalyst.
Xie, W; Yang, D, 2012
)
0.38
" The hazardous dyes MG and MB removal studied under the various conditions like contact time, dye concentration, temperature, pH and adsorbent dosage to examine the adsorption characteristics of the newly synthesized mesoporous AlPO(4) molecular sieves."( Hazardous dyes removal from aqueous solution over mesoporous aluminophosphate with textural porosity by adsorption.
Devi, MR; Kannan, C; Muthuraja, K, 2013
)
0.39
" The present study established the feasibility to formulate a dosage form with improved efficacy and reduced aluminum concentration for vaccination."( Evaluation of synergistic effect of biodegradable polymeric nanoparticles and aluminum based adjuvant for improving vaccine efficacy.
Bansal, V; Brahmne, HG; Dalela, M; Kumar, M; Singh, H, 2014
)
0.4
"70) and dosage (≥1."( Risk factors for granulomas in children following immunization with aluminium-adsorbed vaccines: A Danish population-based cohort study.
Hoffmann, SS; Hviid, A; Johansen, JD; Thiesson, EM, 2022
)
0.72
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Occurs in Manufacturing (4 Product(s))

Product Categories

Product CategoryProducts
Other2
Snacks, Snacks salés, Amuse-gueules, Blinis1
Pflanzliche Lebensmittel und Getränke, Pflanzliche Lebensmittel, Getreide und Kartoffeln, Getreideprodukte, en:Specific products, Teigwaren, en:Products for specific diets, Glutenfrei, Spaghettis1

Products

ProductBrandCategoryCompounds Matched from IngredientsDate Retrieved

Research

Studies (312)

TimeframeStudies, This Drug (%)All Drugs %
pre-199068 (21.79)18.7374
1990's47 (15.06)18.2507
2000's110 (35.26)29.6817
2010's75 (24.04)24.3611
2020's12 (3.85)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 77.65

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 Index77.65 (24.57)
Research Supply Index5.90 (2.92)
Research Growth Index4.58 (4.65)
Search Engine Demand Index136.10 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (77.65)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials31 (9.34%)5.53%
Reviews10 (3.01%)6.00%
Case Studies2 (0.60%)4.05%
Observational0 (0.00%)0.25%
Other289 (87.05%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (8)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Effectiveness Evaluation of Mixed Gel of Hydrocortisone and Aluminium Phosphate Preventing Endoscopic Submucosal Dissection Postoperative Stenosis for Patients With Early Esophageal Cancer Invading More Than 2/3 Esophageal Perimeter [NCT03165344]66 participants (Actual)Interventional2017-02-10Completed
[NCT02200237]Phase 2366 participants (Actual)Interventional2014-09-30Completed
A Phase I, Multicenter, Observer-Blinded, Randomized, Placebo-Controlled, Dose Escalation Trial to Evaluate the Safety and Immunogenicity of the OSP:rTTHc Cholera Conjugate Vaccine in 19 to 45 Years Old Healthy Korean Participants [NCT05559983]Phase 1150 participants (Anticipated)Interventional2022-12-05Recruiting
Safety and Immunogenicity Study to Evaluate Single- or Two-Dose Regimens Of RSV F Vaccine With and Without Aluminum Phosphate or Matrix-M1™ Adjuvants In Clinically-Stable Older Adults [NCT03026348]Phase 2300 participants (Actual)Interventional2017-01-31Completed
Phase I, Double-Blinded, Placebo-Controlled Dosage-Escalation Study of the Safety and Immunogenicity of EBA-175 RII-NG Malaria Vaccine Administered Intramuscularly [NCT00347555]Phase 180 participants (Actual)Interventional2006-05-31Completed
A Randomized, Double-Blind, Controlled (Positive and Placebo) Phase I Clinical Trial to Estimate Safty and Immunogenicity of the SCT1000 in Healthy Women Aged 18 to 45 Years [NCT04921111]Phase 1240 participants (Anticipated)Interventional2021-07-02Recruiting
A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults [NCT01986010]Phase 1190 participants (Actual)Interventional2013-11-25Completed
Phase IV, Open Label Trial to Evaluate Immunogenicity of Tdap Vaccine in Post-Partum Women to Optimize Vaccination Schedule for Women Who May Have a Subsequent Child [NCT01711645]Phase 455 participants (Actual)Interventional2012-10-26Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT01711645 (27) [back to overview]Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 12
NCT01711645 (27) [back to overview]ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 18
NCT01711645 (27) [back to overview]ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 24
NCT01711645 (27) [back to overview]ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 6
NCT01711645 (27) [back to overview]ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 2
NCT01711645 (27) [back to overview]ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 6
NCT01711645 (27) [back to overview]Geometric Mean Fold Rise in Serum IgG by ELISA at Month 12
NCT01711645 (27) [back to overview]Geometric Mean Fold Rise in Serum IgG by ELISA at Month 18
NCT01711645 (27) [back to overview]Geometric Mean Fold Rise in Serum IgG by ELISA at Month 24
NCT01711645 (27) [back to overview]Geometric Mean Fold Rise in Serum IgG by ELISA at Month 6
NCT01711645 (27) [back to overview]Geometric Mean Fold Rise in Serum IgG by ELISA at Week 6
NCT01711645 (27) [back to overview]ELISA GMC of Breast Milk IgA to FHA at Baseline.
NCT01711645 (27) [back to overview]ELISA GMC of Breast Milk IgA to FHA at Month 6.
NCT01711645 (27) [back to overview]ELISA GMC of Breast Milk IgA to FHA at Week 2.
NCT01711645 (27) [back to overview]ELISA GMC of Breast Milk IgA to FHA at Week 6.
NCT01711645 (27) [back to overview]ELISA GMC of Breast Milk IgA to Pertussis Toxin (PT) at Baseline.
NCT01711645 (27) [back to overview]ELISA GMC of Breast Milk IgA to PT at Month 6
NCT01711645 (27) [back to overview]ELISA GMC of Breast Milk IgA to PT at Week 2
NCT01711645 (27) [back to overview]ELISA GMC of Breast Milk IgA to PT at Week 6
NCT01711645 (27) [back to overview]Geometric Mean Fold Rise in Serum Immunoglobulin G (IgG) by ELISA at Week 2
NCT01711645 (27) [back to overview]Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 18
NCT01711645 (27) [back to overview]Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 24
NCT01711645 (27) [back to overview]Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 6
NCT01711645 (27) [back to overview]Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 2
NCT01711645 (27) [back to overview]Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 6
NCT01711645 (27) [back to overview]ELISA Geometric Mean Concentrations (GMC) of Serum IgG to PT, FHA, PRN and FIM at Baseline
NCT01711645 (27) [back to overview]ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 12
NCT01986010 (11) [back to overview]Percentage of Participants Who Discontinued Study Treatment Due to an AE
NCT01986010 (11) [back to overview]Percentage of Participants With a Serious Adverse Event (SAE)
NCT01986010 (11) [back to overview]Percentage of Participants With a Serious Vaccine-Related Adverse Event
NCT01986010 (11) [back to overview]Percentage of Participants With a Systemic AE
NCT01986010 (11) [back to overview]Percentage of Participants With an Adverse Event (AE)
NCT01986010 (11) [back to overview]Percentage of Participants With an Injection-site AE
NCT01986010 (11) [back to overview]Percentage of Participants With Events of Clinical Interest (ECI)
NCT01986010 (11) [back to overview]Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides
NCT01986010 (11) [back to overview]Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma
NCT01986010 (11) [back to overview]Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2
NCT01986010 (11) [back to overview]Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3

Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 12

Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 12 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ. (NCT01711645)
Timeframe: Prior to and 12 months after vaccination

InterventionParticipants (Count of Participants)
PTFHAPRNFIM
Adacel® Tdap Vaccine552826

[back to top]

ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 18

Blood was collected from participants at 18 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI. (NCT01711645)
Timeframe: 18 months post vaccination

InterventionEU/mL (Geometric Mean)
PTFHAPRNFIM
Adacel® Tdap Vaccine15.144.6121.1330.7

[back to top]

ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 24

Blood was collected from participants at 24 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI. (NCT01711645)
Timeframe: 24 months post vaccination

InterventionEU/mL (Geometric Mean)
PTFHAPRNFIM
Adacel® Tdap Vaccine10.839.0114.1298.0

[back to top]

ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 6

Blood was collected from participants at 6 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI. (NCT01711645)
Timeframe: 6 months post vaccination

InterventionEU/mL (Geometric Mean)
PTFHAPRNFIM
Adacel® Tdap Vaccine19.262.4212.3492.8

[back to top]

ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 2

Blood was collected from participants at 2 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI. (NCT01711645)
Timeframe: 2 weeks post vaccination

InterventionEU/mL (Geometric Mean)
PTFHAPRNFIM
Adacel® Tdap Vaccine51.5154.3581.51156.3

[back to top]

ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 6

Blood was collected from participants at 6 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI. (NCT01711645)
Timeframe: 6 weeks post vaccination

InterventionEU/mL (Geometric Mean)
PTFHAPRNFIM
Adacel® Tdap Vaccine37.5126.1496.8905.1

[back to top]

Geometric Mean Fold Rise in Serum IgG by ELISA at Month 12

Blood was collected from participants at baseline prior to vaccination and at 12 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI. (NCT01711645)
Timeframe: Prior to and 12 months following vaccination

InterventionFold Rise (Geometric Mean)
PTFHAPRNFIM
Adacel® Tdap Vaccine1.62.55.16.9

[back to top]

Geometric Mean Fold Rise in Serum IgG by ELISA at Month 18

Blood was collected from participants at baseline prior to vaccination and at 18 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI. (NCT01711645)
Timeframe: Prior to and 18 months following vaccination

InterventionFold Rise (Geometric Mean)
PTFHAPRNFIM
Adacel® Tdap Vaccine1.62.44.66.8

[back to top]

Geometric Mean Fold Rise in Serum IgG by ELISA at Month 24

Blood was collected from participants at baseline prior to vaccination and at 24 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI. (NCT01711645)
Timeframe: Prior to and 24 months following vaccination

InterventionFold Rise (Geometric Mean)
PTFHAPRNFIM
Adacel® Tdap Vaccine1.42.24.97.0

[back to top]

Geometric Mean Fold Rise in Serum IgG by ELISA at Month 6

Blood was collected from participants at baseline prior to vaccination and at 6 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI. (NCT01711645)
Timeframe: Prior to and 6 months following vaccination

InterventionFold Rise (Geometric Mean)
PTFHAPRNFIM
Adacel® Tdap Vaccine1.93.48.110.1

[back to top]

Geometric Mean Fold Rise in Serum IgG by ELISA at Week 6

Blood was collected from participants at baseline prior to vaccination and at 6 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI. (NCT01711645)
Timeframe: Prior to and 6 weeks following vaccination

InterventionFold Rise (Geometric Mean)
PTFHAPRNFIM
Adacel® Tdap Vaccine3.56.719.118.6

[back to top]

ELISA GMC of Breast Milk IgA to FHA at Baseline.

Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval. (NCT01711645)
Timeframe: Baseline (prior to vaccination)

InterventionEU/mL (Geometric Mean)
Adacel® Tdap Vaccine28.3

[back to top]

ELISA GMC of Breast Milk IgA to FHA at Month 6.

Breast milk was collected from participants at 6 months post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval. (NCT01711645)
Timeframe: 6 months post vaccination

InterventionEU/mL (Geometric Mean)
Adacel® Tdap Vaccine5.2

[back to top]

ELISA GMC of Breast Milk IgA to FHA at Week 2.

Breast milk was collected from participants at 2 weeks post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval. (NCT01711645)
Timeframe: 2 weeks post vaccination

InterventionEU/mL (Geometric Mean)
Adacel® Tdap Vaccine5.4

[back to top]

ELISA GMC of Breast Milk IgA to FHA at Week 6.

Breast milk was collected from participants at 6 weeks post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the FHA at this timepoint, all participants had a concentration of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported. (NCT01711645)
Timeframe: 6 weeks post vaccination

InterventionEU/mL (Geometric Mean)
Adacel® Tdap Vaccine5.0

[back to top]

ELISA GMC of Breast Milk IgA to Pertussis Toxin (PT) at Baseline.

Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the PT antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval. The lower limit of quantitation (LLOQ) of the assay was 10. Results of <10 were reported as half the LLOQ (5). (NCT01711645)
Timeframe: Baseline (prior to vaccination)

InterventionEU/mL (Geometric Mean)
Adacel® Tdap Vaccine28.8

[back to top]

ELISA GMC of Breast Milk IgA to PT at Month 6

Breast milk was collected from participants at 6 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported. (NCT01711645)
Timeframe: 6 months post vaccination

InterventionEU/mL (Geometric Mean)
Adacel® Tdap Vaccine5.0

[back to top]

ELISA GMC of Breast Milk IgA to PT at Week 2

Breast milk was collected from participants at 2 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported. (NCT01711645)
Timeframe: 2 weeks post vaccination

InterventionEU/mL (Geometric Mean)
Adacel® Tdap Vaccine5.0

[back to top]

ELISA GMC of Breast Milk IgA to PT at Week 6

Breast milk was collected from participants at 6 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported. (NCT01711645)
Timeframe: 6 weeks post vaccination

InterventionEU/mL (Geometric Mean)
Adacel® Tdap Vaccine5.0

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Geometric Mean Fold Rise in Serum Immunoglobulin G (IgG) by ELISA at Week 2

Blood was collected from participants at baseline prior to vaccination and at 2 weeks after vaccination for assessment of IgG by ELISA against the pertussis toxin (PT), filamentous hemaggluttinin (FHA), pertactin (PRN) and fimbrae (FIM) antigens. Antibody concentrations were reported as ELISA units per milliliter (EU/mL). The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% confidence interval (CI). (NCT01711645)
Timeframe: Prior to and 2 weeks following vaccination

InterventionFold Rise (Geometric Mean)
PTFHAPRNFIM
Adacel® Tdap Vaccine4.88.621.622.4

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Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 18

Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 18 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ. (NCT01711645)
Timeframe: Prior to and 18 months after vaccination

InterventionParticipants (Count of Participants)
PTFHAPRNFIM
Adacel® Tdap Vaccine372526

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Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 24

Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 24 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ. (NCT01711645)
Timeframe: Prior to and 24 months after vaccination

InterventionParticipants (Count of Participants)
PTFHAPRNFIM
Adacel® Tdap Vaccine121920

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Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 6

Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 6 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ. (NCT01711645)
Timeframe: Prior to and 6 months after vaccination

InterventionParticipants (Count of Participants)
PTFHAPRNFIM
Adacel® Tdap Vaccine5183429

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Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 2

Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 2 weeks after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ. (NCT01711645)
Timeframe: Prior to and 2 weeks after vaccination

InterventionParticipants (Count of Participants)
PTFHAPRNFIM
Adacel® Tdap Vaccine31454334

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Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 6

Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 6 weeks after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ. (NCT01711645)
Timeframe: Prior to and 6 weeks after vaccination

InterventionParticipants (Count of Participants)
PTFHAPRNFIM
Adacel® Tdap Vaccine21444234

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ELISA Geometric Mean Concentrations (GMC) of Serum IgG to PT, FHA, PRN and FIM at Baseline

Blood was collected from participants at baseline prior to vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. Antibody concentrations were reported as ELISA units per milliliter (EU/mL). A value of 5 EU/mL was imputed for results reported as below the lower limit of quantitation (LLOQ) (<10 EU/mL). The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI. (NCT01711645)
Timeframe: Baseline (prior to vaccination)

InterventionEU/mL (Geometric Mean)
PTFHAPRNFIM
Adacel® Tdap Vaccine6.615.920.338.1

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ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 12

Blood was collected from participants at 12 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI. (NCT01711645)
Timeframe: 12 months post vaccination

InterventionEU/mL (Geometric Mean)
PTFHAPRNFIM
Adacel® Tdap Vaccine15.146.2141.1368.7

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Percentage of Participants Who Discontinued Study Treatment Due to an AE

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. (NCT01986010)
Timeframe: Up to Month 6

InterventionPercentage of participants (Number)
HCMV Seropositive (+) V160 10u Intramuscular (IM)0
HCMV + V160 30u IM7.1
HCMV+ V160 100u IM0
HCMV+ V160 100u MAPA IM0
HCMV+ V160 250u IM0
HCMV+ Placebo IM0
HCMV+ V160 30u ID0
HCMV+ Placebo ID0
HCMV Seronegative (-) V160 10u IM0
HCMV- V160 30u IM0
HCMV- V160 30u MAPA IM0
HCMV- V160 100u IM9.1
HCMV- V160 100u MAPA IM0
HCMV- V160 250u IM9.1
HCMV- V160 Placebo IM0
HCMV- V160 30u ID9.1
HCMV- Placebo ID0

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Percentage of Participants With a Serious Adverse Event (SAE)

A serious adverse event is any adverse event occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event (NCT01986010)
Timeframe: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)

InterventionPercentage of participants (Number)
HCMV Seropositive (+) V160 10u Intramuscular (IM)0
HCMV + V160 30u IM0
HCMV+ V160 100u IM0
HCMV+ V160 100u MAPA IM0
HCMV+ V160 250u IM0
HCMV+ Placebo IM0
HCMV+ V160 30u ID0
HCMV+ Placebo ID0
HCMV Seronegative (-) V160 10u IM0
HCMV- V160 30u IM0
HCMV- V160 30u MAPA IM0
HCMV- V160 100u IM0
HCMV- V160 100u MAPA IM0
HCMV- V160 250u IM0
HCMV- V160 Placebo IM0
HCMV- V160 30u ID0
HCMV- Placebo ID0

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Percentage of Participants With a Systemic AE

A Systemic AE includes, but is not exclusive of, the following AEs: fatigue, myalgia, headache and joint pain (NCT01986010)
Timeframe: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)

InterventionPercentage of participants (Number)
HCMV Seropositive (+) V160 10u Intramuscular (IM)66.7
HCMV + V160 30u IM64.3
HCMV+ V160 100u IM69.2
HCMV+ V160 100u MAPA IM90.0
HCMV+ V160 250u IM90.9
HCMV+ Placebo IM57.9
HCMV+ V160 30u ID80.0
HCMV+ Placebo ID50.0
HCMV Seronegative (-) V160 10u IM66.7
HCMV- V160 30u IM90.0
HCMV- V160 30u MAPA IM70.0
HCMV- V160 100u IM100.0
HCMV- V160 100u MAPA IM70.0
HCMV- V160 250u IM90.9
HCMV- V160 Placebo IM56.3
HCMV- V160 30u ID100.0
HCMV- Placebo ID100.0

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Percentage of Participants With an Adverse Event (AE)

An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. (NCT01986010)
Timeframe: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)

InterventionPercentage of participants (Number)
HCMV Seropositive (+) V160 10u Intramuscular (IM)75.0
HCMV + V160 30u IM92.9
HCMV+ V160 100u IM84.6
HCMV+ V160 100u MAPA IM100.0
HCMV+ V160 250u IM100.0
HCMV+ Placebo IM57.9
HCMV+ V160 30u ID100.0
HCMV+ Placebo ID50.0
HCMV Seronegative (-) V160 10u IM75.0
HCMV- V160 30u IM90.0
HCMV- V160 30u MAPA IM90.0
HCMV- V160 100u IM100.0
HCMV- V160 100u MAPA IM90.0
HCMV- V160 250u IM90.9
HCMV- V160 Placebo IM56.3
HCMV- V160 30u ID100.0
HCMV- Placebo ID100.0

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Percentage of Participants With an Injection-site AE

Injection-site AEs are defined as redness, swelling, and pain/tenderness. (NCT01986010)
Timeframe: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)

InterventionPercentage of participants (Number)
HCMV Seropositive (+) V160 10u Intramuscular (IM)58.3
HCMV + V160 30u IM85.7
HCMV+ V160 100u IM69.2
HCMV+ V160 100u MAPA IM80.0
HCMV+ V160 250u IM100.0
HCMV+ Placebo IM26.3
HCMV+ V160 30u ID90.0
HCMV+ Placebo ID0.0
HCMV Seronegative (-) V160 10u IM66.7
HCMV- V160 30u IM80.0
HCMV- V160 30u MAPA IM80.0
HCMV- V160 100u IM90.9
HCMV- V160 100u MAPA IM90.0
HCMV- V160 250u IM81.8
HCMV- V160 Placebo IM31.3
HCMV- V160 30u ID100.0
HCMV- Placebo ID50.0

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Percentage of Participants With Events of Clinical Interest (ECI)

An event of clinical interest (ECI) is identified as any overdose, elevated liver values meeting threshold criteria (aspartate aminotransferase or alanine aminotransferase ≥3x upper limit of normal (ULN); total bilirubin ≥2x ULN, and, at the same time, alkaline phosphatase <2xULN). Additionally, confirmed, diagnosed autoimmune conditions are considered ECIs. (NCT01986010)
Timeframe: Up to 18 months

InterventionPercentage of participants (Number)
HCMV Seropositive (+) V160 10u Intramuscular (IM)0
HCMV + V160 30u IM0
HCMV+ V160 100u IM0
HCMV+ V160 100u MAPA IM0
HCMV+ V160 250u IM0
HCMV+ Placebo IM0
HCMV+ V160 30u ID0
HCMV+ Placebo ID0
HCMV Seronegative (-) V160 10u IM0
HCMV- V160 30u IM0
HCMV- V160 30u MAPA IM0
HCMV- V160 100u IM0
HCMV- V160 100u MAPA IM0
HCMV- V160 250u IM0
HCMV- V160 Placebo IM0
HCMV- V160 30u ID0
HCMV- Placebo ID0

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Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides

In response to HCMV-specific stimulation of whole blood specimens the whole Blood Cytokine Stimulation (WBStim) assay was used to detect the secretion of interferon gamma (IFN -γ) by an ELISA assay. Results are presented for the following HCMV proteins: pp65, IE1, and gB. (NCT01986010)
Timeframe: Month 7 (1 month after vaccination 3 at Month 6)

,,,,,,,,,,,,,,
Interventionug/mL (Geometric Mean)
pp65IE1gB
HCMV + V160 30u IM1937040
HCMV Seronegative (-) V160 10u IM64627
HCMV Seropositive (+) V160 10u Intramuscular (IM)1689053
HCMV- Placebo IM or ID556
HCMV- V160 100u IM89407
HCMV- V160 100u MAPA IM81110
HCMV- V160 250u IM28459
HCMV- V160 30u ID24405
HCMV- V160 30u IM973510
HCMV- V160 30u MAPA IM24285
HCMV+ Placebo IM or ID1122416
HCMV+ V160 100u IM791364
HCMV+ V160 100u MAPA IM863527
HCMV+ V160 250u IM2112027
HCMV+ V160 30u ID642762

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Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma

In order to evaluate the cellular immune response to the vaccine(s), the HCMV enzyme-linked immunospot (ELISPOT) assay was used to detect interferon gamma (IFN-γ) secreting HCMV-specific cells from peripheral blood mononuclear cells (PBMCs). Results are expressed as the frequency of spot forming cells (SFCs) per million PBMCs (SFC/10^6 PBMCs). Results are presented for the following HCMV proteins: pp65, Immediate early Protein 1 (IE1), Immediate early Protein 2 (IE2), Glycoprotein B (gB), and also for purified HCMV virion stock. (NCT01986010)
Timeframe: Month 7 (1 month after vaccination 3 at Month 6)

,,,,,,,,,,,,,,
InterventionSFC/10^6 PBMCs (Geometric Mean)
pp65IE1IE2gBVirus
HCMV + V160 30u IM419340101287384
HCMV Seronegative (-) V160 10u IM886776119105668
HCMV Seropositive (+) V160 10u Intramuscular (IM)8198551221951190
HCMV- Placebo IM or ID1912101817
HCMV- V160 100u IM380577146185621
HCMV- V160 100u MAPA IM13259338686777
HCMV- V160 250u IM512742131135413
HCMV- V160 30u ID114517961941741160
HCMV- V160 30u IM468358221479
HCMV- V160 30u MAPA IM8659133438268
HCMV+ Placebo IM or ID800200491401357
HCMV+ V160 100u IM138441930911372134
HCMV+ V160 100u MAPA IM1105370722171348
HCMV+ V160 250u IM1206417932531708
HCMV+ V160 30u ID108037932294937

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Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2

Serum samples for measuring neutralizing antibodies using the Merck NAb assay were collected at months 1 and 2. The LiCor-based near-infrared dye (NIRDye) In-Cell Western (ICW) HCMV microneutralization assay was used to detect and quantify anti-HCMV neutralizing antibodies. Values below the lower limit of titer are represented by NA. (NCT01986010)
Timeframe: Month 1 and 2 (one month after vaccination 1 [Day 1] and vaccination 2 [Month 1])

,,,,,,,,,,,,,,
InterventionGeometric Mean Titer (Geometric Mean)
Month 1Month 2
HCMV + V160 30u IM51865443
HCMV Seronegative (-) V160 10u IM73143
HCMV Seropositive (+) V160 10u Intramuscular (IM)31243144
HCMV- Placebo IM or IDNANA
HCMV- V160 100u IM91288
HCMV- V160 100u MAPA IM134590
HCMV- V160 250u IM281589
HCMV- V160 30u ID183451
HCMV- V160 30u IM95264
HCMV- V160 30u MAPA IM65264
HCMV+ Placebo IM or ID23352313
HCMV+ V160 100u IM62326959
HCMV+ V160 100u MAPA IM66957022
HCMV+ V160 250u IM38314261
HCMV+ V160 30u ID91279412

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Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3

Serum samples for measuring neutralizing antibodies using the Merck Neutralizing Antibody (NAb) assay were collected at month 7. The LiCor-based near-infrared dye (NIRDye) In-Cell Western (ICW) HCMV microneutralization assay was used to detect and quantify anti-HCMV neutralizing antibodies. The primary hypothesis was that for HCMV-seronegative participants, at least 1 of the vaccination groups receiving V160 formulated with or without adjuvant would exhibit higher HCMV-specific neutralizing antibody titers than the placebo group. (NCT01986010)
Timeframe: Month 7 (1 month after vaccination 3 at Month 6)

InterventionGeometric Mean Titer (Geometric Mean)
HCMV Seropositive (+) V160 10u Intramuscular (IM)3301
HCMV + V160 30u IM4177
HCMV+ V160 100u IM7740
HCMV+ V160 100u MAPA IM5701
HCMV+ V160 250u IM3535
HCMV+ V160 30u ID8601
HCMV+ Placebo IM or ID2224
HCMV Seronegative (-) V160 10u IM328
HCMV- V160 30u IM1532
HCMV- V160 30u MAPA IM1361
HCMV- V160 100u IM820
HCMV- V160 100u MAPA IM2573
HCMV- V160 250u IM1241
HCMV- V160 30u ID1261
HCMV- Placebo IM or ID20

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