CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 907 enrolled
Drug / intervention
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine +1 morebiological
Likely dose
Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02842866
NCT02842866Phase 3Completed
CompareCT.gov

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults Age 56 Years and Older

Sanofi Pasteur, a Sanofi Company·interventional·Posted Jul 25, 2016·Updated Apr 5, 2022

In Brief

A Phase 3 clinical trial evaluating Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine and Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined for Meningitis and 2 related conditions. Completed, enrolled 907 participants across 36 sites in 2 countries.

Detailed Summary

The aim of the study was to demonstrate non-inferiority of immunogenicity and evaluate the safety of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid conjugate vaccine (MenACYW conjugate vaccine) compared to a single dose of Meningococcal Polysaccharide Vaccine Serogroups A, C, Y, and W-135 Combined (Menomune® - A/C/Y/W-135) in adults 56 years of age and older in the United States. Primary objective: -To demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW conjugate vaccine compared to those observed following the administration of a single dose of Menomune® - A/C/Y/W-135. Secondary objective: -To compare the serum bactericidal assay using human complement (hSBA) antibody geometric mean titers of meningococcal serogroups A, C, Y, and W following the administration of MenACYW conjugate vaccine to those observed following the administration of Menomune® - A/C/Y/W-135. Observational objectives: * To describe antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA at baseline (before vaccination) and 30 days after vaccination with MenACYW conjugate vaccine or Menomune® - A/C/Y/W-135 in a subset of 100 participants per treatment group. * To describe the safety profile of MenACYW conjugate vaccine compared to that of the licensed Menomune® - A/C/Y/W-135 after a single administration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningitis, Meningococcal Meningitis, Meningococcal Infections
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 25, 2016
Enrollment StartJul 15, 2016
Primary CompletionFeb 13, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 9.9 years ago

Interventions

Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccinebiological

0.5 milliliter (mL), Intramuscular (IM), single dose on Day 0.

Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combinedbiological

0.5 mL, Subcutaneous (SC), single dose on Day 0.