CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,797 enrolled
Drug / intervention
Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine) +7 morebiological
Likely dose
Not stated in 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/NCT03673462
NCT03673462Phase 3Completed
CompareCT.gov

A Randomized Study to Describe the Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

Sanofi Pasteur, a Sanofi Company·interventional·Posted Sep 17, 2018·Updated Dec 14, 2023

In Brief

A Phase 3 clinical trial evaluating Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine), Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®), and 6 other interventions for Healthy Volunteers (Meningococcal Infection). Completed, enrolled 2,797 participants across 69 sites in 2 countries.

Detailed Summary

The primary objective of this study was to describe the safety profile of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate Vaccine and Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®) Conjugate Vaccine when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers (Meningococcal Infection)
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedSep 17, 2018
Enrollment StartSep 17, 2018
Primary CompletionMar 16, 2023
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 7.8 years ago

Interventions

Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine)biological

Pharmaceutical form: Liquid solution. Route of administration: Intramuscular

Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®)biological

Pharmaceutical form: Lyophilized powder combined with liquid components Route of administration: Intramuscular

Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccinebiological

Pharmaceutical form: Liquid DTaP-IPV to reconstitute lyophilized ActHIB Route of administration: Intramuscular

Pneumococcal 13-valent Conjugate Vaccinebiological

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Rotavirus Vaccinebiological

Pharmaceutical form: Oral solution Route of administration: Oral

Hepatitis B Vaccinebiological

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Measles, Mumps, and Rubella Virus Vaccinebiological

Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous

Varicella Virus Vaccinebiological

Pharmaceutical form: Suspension for injection Route of administration: Subcutaneous