CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,183 enrolled
Drug / intervention
MenACYW conjugate vaccine +4 morebiological
Likely dose
MMR 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/NCT03205371
NCT03205371Phase 3Completed
CompareCT.gov

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Other Pediatric Vaccines in Healthy Toddlers

Sanofi Pasteur, a Sanofi Company·interventional·Posted Jul 2, 2017·Updated Apr 5, 2022

In Brief

A Phase 3 clinical trial evaluating MenACYW conjugate vaccine, MMR, and 3 other interventions for Meningitis, Meningococcal. Completed, enrolled 1,183 participants across 37 sites in 4 countries.

Detailed Summary

This Phase III, open-label, randomized, parallel-group, active-controlled, multicenter study was conducted to assess the immunogenicity and safety of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine when administered alone and in combination with other pediatric vaccines in healthy toddlers in South Korea, Thailand, the Russian Federation, and Mexico. Primary Objective: * To describe the immunogenicity profile of MenACYW Conjugate vaccine administered alone or concomitantly with licensed pediatric vaccine(s) (measles-mumps-rubella vaccine \[MMR\] + Varicella, diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type-b Conjugate vaccine \[DTaP-IPV-HB-Hib\], or pneumococcal Conjugate vaccine \[PCV13\]). Secondary Objective: * To describe the immunogenicity profile of licensed pediatric vaccine(s) (MMR + Varicella, DTaP-IPV-HB-Hib, or PCV13) when administered alone or concomitantly with MenACYW Conjugate vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningitis, Meningococcal
CountriesMexico, Russia, South Korea, Thailand
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 2, 2017
Enrollment StartNov 7, 2016
Primary CompletionJul 19, 2018
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9 years ago

Interventions

MenACYW conjugate vaccinebiological

Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; 0.5 milliliter (mL), Intramuscular

MMRbiological

Measles, Mumps, and Rubella Virus Vaccine Live; 0.5 mL, Subcutaneous

Varicellabiological

Varicella Virus Vaccine Live; 0.5 mL, Subcutaneous

DTaP-IPV-HB-Hibbiological

Diphtheria, Tetanus, Pertussis (acellular component), Hepatitis B, Poliomyelitis (inactivated), and Haemophilus influenzae type-b conjugate vaccine (adsorbed); 0.5 mL, Intramuscular

PCV13biological

Pneumococcal 13-valent Conjugate Vaccine; 0.5 mL, Intramuscular