CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 463 enrolled
Drug / intervention
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine) +3 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/NCT04490018
NCT04490018Phase 3Completed

Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix®, and When Administered Alone or Concomitantly With 9vHPV and Tdap-IPV Vaccines in Healthy Adolescents

Sanofi Pasteur, a Sanofi Company·interventional·Posted Jul 28, 2020·Updated Sep 12, 2025

In Brief

A Phase 3 clinical trial evaluating Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine), Meningococcal group A, C, W-135, and Y conjugate vaccine, and 2 other interventions for Meningococcal Immunisation and Healthy Volunteers. Completed, enrolled 463 participants across 23 sites in 4 countries.

Detailed Summary

Primary Objective: To demonstrate the non-inferiority of the seroprotection rate (serum bactericidal assay using human complement \[hSBA\] titer greater than or equal to \[\>=\] 1:8) to meningococcal serogroups A, C, W, and Y following the administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate vaccine (MenACYW Conjugate vaccine) (Group 1) compared to a single dose of Nimenrix® (Group 2). Secondary Objective: To describe: * the antibody response of meningococcal serogroups A, C, W, and Y measured by hSBA, before and 1 month following meningococcal vaccination administered alone (Groups 1 and 2) or concomitantly with 9-valent human papilloma virus (9vHPV) and tetanus, diphtheria, and acellular pertussis - inactivated polio vaccine \[adsorbed, reduced antigen(s) content\] (Tdap-IPV) vaccines (Group 3). * the antibody response of meningococcal serogroup C measured by hSBA and serum bactericidal assay using baby rabbit complement (rSBA), before vaccination and at Day 31 after vaccination with MenACYW Conjugate vaccine or Nimenrix® (Groups 1 and 2) according to MenC primed status. * the antibody response against antigens of 9vHPV and Tdap-IPV vaccines, before and 1 month following vaccination. * the safety profile in each group after each and any vaccination.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesHungary, Italy, Singapore, Spain
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJul 28, 2020
Enrollment StartMar 16, 2021
Primary CompletionMay 11, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.9 years ago

Interventions

Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine)biological

Pharmaceutical form: Liquid solution for injection Route of administration: Intramuscular

Meningococcal group A, C, W-135, and Y conjugate vaccinebiological

Pharmaceutical form: Powder and solvent for solution for injection Route of administration: Intramuscular

Human Papillomavirus 9-valent Vaccine (9vHPV)biological

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Tdap-IPV)biological

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular