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NCT01890759

Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation

Completed Phase 3 Results posted Last updated 19 April 2022
What this trial tests

Phase 3 trial testing Meningococcal Diphtheria Toxoid Vaccine in Meningitis in 300 participants. Completed in 12 April 2016.

Timeline
25 June 2013
Primary endpoint
12 April 2016
12 April 2016

Quick facts

Lead sponsorSanofi Pasteur, a Sanofi Company
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment300
Start date25 June 2013
Primary completion12 April 2016
Estimated completion12 April 2016
Sites8 locations across Russia, India

Drugs / interventions tested

Conditions studied

Sponsor

Sanofi Pasteur, a Sanofi Company — full company profile →

Who can join

Adults 9 Months to 17 Months, any sex, with Meningitis or Meningococcal Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® Primary · Day 0 (pre-vaccination) and Day 28 post-second vaccination

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. Seroprotection was defined as antibody titers ≥ 1:8.

Serogroup A; Pre vaccination 1 (N=77,169)
GroupValue95% CI
Russian Federation45.5
India55.0
Serogroup A; Post vaccination 2 (N=77,166)
GroupValue95% CI
Russian Federation98.7
India97.6
Serogroup C; Pre vaccination 1 (N=77,169)
GroupValue95% CI
Russian Federation6.5
India4.7
Serogroup C; Post vaccination 2 (N=77,169)
GroupValue95% CI
Russian Federation92.2
India95.9
Serogroup Y; Pre vaccination 1 (N=77,169)
GroupValue95% CI
Russian Federation5.2
India6.5
Serogroup Y; Post vaccination 2 (N=77,169)
GroupValue95% CI
Russian Federation96.1
India98.2
Serogroup W 135; Pre vaccination 1 (N=77,169)
GroupValue95% CI
Russian Federation7.8
India5.3
Serogroup W 135; Post vaccination 2 (N=77,169)
GroupValue95% CI
Russian Federation100.0
India99.4
Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® Secondary · Day 0 (pre-vaccination) and Day 28 post-vaccination

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:4.

Serogroup A; Pre vaccination 1 (N=77,169)
GroupValue95% CI
Russian Federation88.3
India97.6
Serogroup A; Post vaccination 2 (N=77,166)
GroupValue95% CI
Russian Federation100.0
India99.4
Serogroup C; Pre vaccination 1 (N=77,169)
GroupValue95% CI
Russian Federation19.5
India14.2
Serogroup C; Post vaccination 2 (N=77,169)
GroupValue95% CI
Russian Federation98.7
India98.8
Serogroup Y; Pre vaccination 1 (N=77,169)
GroupValue95% CI
Russian Federation9.1
India11.8
Serogroup Y; Post vaccination 2 (N=77,169)
GroupValue95% CI
Russian Federation98.7
India100.0
Serogroup W 135; Pre vaccination 1 (N=77,169)
GroupValue95% CI
Russian Federation14.3
India10.7
Serogroup W 135; Post vaccination 2 (N=77,169)
GroupValue95% CI
Russian Federation100.0
India100.0
Percentage of Participants With At Least Four-Fold Rise in Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® Secondary · Day 0 (pre-vaccination) and Day 28 post-vaccination

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.

Serogroup A (N=77,166)
GroupValue95% CI
Russian Federation90.9
India84.9
Serogroup C (N=77,169)
GroupValue95% CI
Russian Federation76.6
India92.3
Serogroup Y (N=77,169)
GroupValue95% CI
Russian Federation90.9
India92.3
Serogroup W 135 (N=77,169)
GroupValue95% CI
Russian Federation90.9
India97.0
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® Secondary · Day 0 (pre-vaccination) and Day 28 post-vaccination

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:8.

Serogroup A; Pre vaccination 1 (N=77,169)
GroupValue95% CI
Russian Federation45.5
India55.0
Serogroup A; Post vaccination 2 (N=77,166)
GroupValue95% CI
Russian Federation98.7
India97.6
Serogroup C; Pre vaccination 1 (N=77,169)
GroupValue95% CI
Russian Federation6.5
India4.7
Serogroup C; Post vaccination 2 (N=77,169)
GroupValue95% CI
Russian Federation92.2
India95.9
Serogroup Y; Pre vaccination 1 (N=77,169)
GroupValue95% CI
Russian Federation5.2
India6.5
Serogroup Y; Post vaccination 2 (N=77,169)
GroupValue95% CI
Russian Federation96.1
India98.2
Serogroup W-135; Pre vaccination 1 (N=77,169)
GroupValue95% CI
Russian Federation7.8
India5.3
Serogroup W-135; Post vaccination 2 (N=77,169)
GroupValue95% CI
Russian Federation100.0
India99.4
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® Secondary · Day 0 (pre-vaccination) and Day 28 post-vaccination

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay. The threshold was defined as antibody titers ≥ 1:8.

Serogroup A; Pre vaccination 1 (N=75,165)
GroupValue95% CI
Russian Federation25.3
India4.8
Serogroup A; Post vaccination 2 (N=77,161)
GroupValue95% CI
Russian Federation100.0
India98.8
Serogroup C; Pre vaccination 1 (N=76,166)
GroupValue95% CI
Russian Federation5.3
India10.8
Serogroup C; Post vaccination 2 (N=77,166)
GroupValue95% CI
Russian Federation97.4
India94.0
Serogroup Y; Pre vaccination 1 (N=76,166)
GroupValue95% CI
Russian Federation84.2
India84.3
Serogroup Y; Post vaccination 2 (N=77,164)
GroupValue95% CI
Russian Federation100.0
India100.0
Serogroup W-135; Pre vaccination 1 (N=76,165)
GroupValue95% CI
Russian Federation27.6
India18.2
Serogroup W-135; Post vaccination 2 (N=77,163)
GroupValue95% CI
Russian Federation100.0
India100.0
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® Secondary · Day 0 (pre-vaccination) and Day 28 post-vaccination

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:4.

Serogroup A; Pre vaccination 1 (N=77,169)
GroupValue95% CI
Russian Federation88.3
India97.6
Serogroup A; Post vaccination 2 (N=77,166)
GroupValue95% CI
Russian Federation100.0
India99.4
Serogroup C; Pre vaccination 1 (N=77,169)
GroupValue95% CI
Russian Federation19.5
India14.2
Serogroup C; Post vaccination 2 (N=77,169)
GroupValue95% CI
Russian Federation98.7
India98.8
Serogroup Y; Pre vaccination 1 (N=77,169)
GroupValue95% CI
Russian Federation9.1
India11.8
Serogroup Y; Post vaccination 2 (N=77,169)
GroupValue95% CI
Russian Federation98.7
India100.0
Serogroup W-135; Pre vaccination 1 (N=77,169)
GroupValue95% CI
Russian Federation14.3
India10.7
Serogroup W-135; Post vaccination 2 (N=77,169)
GroupValue95% CI
Russian Federation100.0
India100.0
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® Secondary · Day 0 (pre-vaccination) and Day 28 post-vaccination

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay. The threshold was defined as antibody titers ≥ 1:4.

Serogroup A; Pre vaccination 1 (N=75,165)
GroupValue95% CI
Russian Federation26.7
India5.5
Serogroup A; Post vaccination 2 (N=77,161)
GroupValue95% CI
Russian Federation100.0
India98.8
Serogroup C; Pre vaccination 1 (N=76,166)
GroupValue95% CI
Russian Federation5.3
India11.4
Serogroup C; Post vaccination 2 (N=77,166)
GroupValue95% CI
Russian Federation97.4
India94.0
Serogroup Y; Pre vaccination 1 (N=76,166)
GroupValue95% CI
Russian Federation84.2
India84.3
Serogroup Y; Post vaccination 2 (N=77,164)
GroupValue95% CI
Russian Federation100.0
India100.0
Serogroup W-135; Pre vaccination 1 (N=76,165)
GroupValue95% CI
Russian Federation27.6
India19.4
Serogroup W-135; Post vaccination 2 (N=77,163)
GroupValue95% CI
Russian Federation100.0
India100.0
Percentage of Participants With At Least Four-Fold Rise in Threshold Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® Secondary · Day 0 (pre-vaccination) and Day 28 post-vaccination

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.

Serogroup A (N=77,166)
GroupValue95% CI
Russian Federation90.9
India84.9
Serogroup C (N=77,169)
GroupValue95% CI
Russian Federation76.6
India92.3
Serogroup Y (N=77,169)
GroupValue95% CI
Russian Federation90.9
India92.3
Serogroup W 135 (N=77,169)
GroupValue95% CI
Russian Federation90.9
India97.0
Percentage of Participants With At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Baby Rabbit Complement Following Vaccination With Menactra® Secondary · Day 0 (pre-vaccination) and Day 28 post-vaccination

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay.

Serogroup A (N=75,158)
GroupValue95% CI
Russian Federation96.0
India96.8
Serogroup C (N=76,163)
GroupValue95% CI
Russian Federation94.7
India92.0
Serogroup Y (N=76,161)
GroupValue95% CI
Russian Federation68.4
India66.5
Serogroup W 135 (N=76,159)
GroupValue95% CI
Russian Federation96.1
India96.2
Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® Secondary · Day 0 (pre-vaccination) and Day 28 post-vaccination

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.

Serogroup A; Pre vaccination 1 (N=77,169)
GroupValue95% CI
Russian Federation5.734.92 – 6.68
India6.825.94 – 7.83
Serogroup A; Post vaccination 2 (N=77,166)
GroupValue95% CI
Russian Federation171126 – 232
India95.277.4 – 117
Serogroup C; Pre vaccination 1 (N=77,169)
GroupValue95% CI
Russian Federation2.462.20 – 2.75
India2.502.18 – 2.86
Serogroup C; Post vaccination 2 (N=77,169)
GroupValue95% CI
Russian Federation49.333.8 – 71.8
India128102 – 160
Serogroup Y; Pre vaccination 1 (N=77,169)
GroupValue95% CI
Russian Federation2.352.04 – 2.72
India2.492.16 – 2.86
Serogroup Y; Post vaccination 2 (N=77,169)
GroupValue95% CI
Russian Federation54.941.3 – 73.0
India10484.8 – 128
Serogroup W 135; Pre vaccination 1 (N=77,169)
GroupValue95% CI
Russian Federation2.572.15 – 3.08
India2.452.12 – 2.82
Serogroup W 135; Post vaccination 2 (N=77,169)
GroupValue95% CI
Russian Federation11492.3 – 140
India201167 – 241
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® Secondary · Day 0 (pre-vaccination) and Day 28 post-vaccination

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR.

Serogroup A; Pre vaccination 1 (N=75,165)
GroupValue95% CI
Russian Federation6.473.93 – 10.6
India2.552.16 – 3.02
Serogroup A; Post vaccination 2 (N=77,161)
GroupValue95% CI
Russian Federation19401612 – 2336
India14261165 – 1746
Serogroup C; Pre vaccination 1 (N=76,166)
GroupValue95% CI
Russian Federation2.382.00 – 2.82
India3.272.62 – 4.09
Serogroup C; Post vaccination 2 (N=77,166)
GroupValue95% CI
Russian Federation326240 – 444
India781577 – 1057
Serogroup Y; Pre vaccination 1 (N=76,166)
GroupValue95% CI
Russian Federation87.355.5 – 137
India95.271.7 – 126
Serogroup Y; Post vaccination 2 (N=77,164)
GroupValue95% CI
Russian Federation734618 – 872
India805669 – 968
Serogroup W 135; Pre vaccination 1 (N=76,165)
GroupValue95% CI
Russian Federation5.663.77 – 8.49
India4.443.40 – 5.80
Serogroup W 135; Post vaccination 2 (N=77,163)
GroupValue95% CI
Russian Federation1260967 – 1640
India1134913 – 1409
Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra® Secondary · Day 0 (pre-vaccination) and Day 28 post-vaccination

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.

Serogroup A (N=77,166)
GroupValue95% CI
Russian Federation29.821.4 – 41.5
India13.910.8 – 18.1
Serogroup C (N=77,169)
GroupValue95% CI
Russian Federation20.013.8 – 29.2
India51.339.4 – 66.8
Serogroup Y (N=77,169)
GroupValue95% CI
Russian Federation23.416.6 – 32.8
India41.932.8 – 53.6
Serogroup W 135 (N=77,169)
GroupValue95% CI
Russian Federation44.232.7 – 59.8
India82.265.4 – 103

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.. Reporting threshold: 5.00%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Russian Federation
Serious: 1/100 (1%)
Deaths: 0/100
India
Serious: 3/199 (2%)
Deaths: 0/199

Serious adverse events (4 terms)

ReactionSystemRussian FederationIndia
Abscess limbInfections and infestations——
Lower respiratory tract infectionInfections and infestations——
NasopharyngitisInfections and infestations——
Respiratory tract infectionInfections and infestations——
Other adverse events (10 terms — click to expand)

ReactionSystemRussian FederationIndia
Injection site TendernessGeneral disorders——
Appetite lostMetabolism and nutrition disorders——
Injection site ErythemaGeneral disorders——
IrritabilityPsychiatric disorders——
Crying abnormalPsychiatric disorders——
VomitingGastrointestinal disorders——
FeverGeneral disorders——
DrowsinessNervous system disorders——
Injection site SwellingGeneral disorders——
Upper respiratory tract infectionInfections and infestations——

Most-reported serious reactions: Abscess limb, Lower respiratory tract infection, Nasopharyngitis, Respiratory tract infection.

Data from ClinicalTrials.gov NCT01890759 adverse events section.

Sponsor's own description

The purpose of this study is to assess the immunogenicity and safety of Menactra® vaccine given as a two-dose series in infants and toddlers. Primary Objectives: * To assess the seroprotection rate (percentage of subjects with a serum bactericidal assay using human complement \[SBA-HC\] titer ≥ 1:8) 28 days after the second of 2 doses of Menactra® administered 3 to 6 months apart. Secondary Objectives: * To assess the immune responses to meningococcal antigens (serogroups A, C, Y, and W-135) 28 days following the second vaccination with Menactra® using SBA-HC and SBA-BR titers. * To assess the safety profile of Menactra® after each and any vaccination.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Meningitis

Currently open trials in the same condition.

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Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01890759.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing