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Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or With Two Other Vaccines in Healthy Adolescents

NCT04490018 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 463

Last updated 2025-09-12

Study results available
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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.

Conditions

  • Meningococcal Immunisation
  • Healthy Volunteers

Interventions

BIOLOGICAL

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

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

BIOLOGICAL

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

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

BIOLOGICAL

Human Papillomavirus 9-valent Vaccine (9vHPV)

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

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

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-16
Primary Completion
2022-05-11
Completion
2022-05-11
FDA Drug
Yes

Countries

  • Hungary
  • Italy
  • Singapore
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04490018 on ClinicalTrials.gov