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Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to Two Meningococcal Reference Vaccines in European Toddlers

NCT03890367 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 707

Last updated 2025-09-15

Study results available
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Summary

Primary Objective:

To demonstrate:

* the non-inferiority of the seroprotection rate (antibody titers greater than or equal to \[\>=\] 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate or Nimenrix® as measured by serum bactericidal assay using human complement (hSBA). If this non-inferiority was demonstrated, then
* the non-inferiority of the antibody response (geometric mean titers \[GMT\]). If this non-inferiority was demonstrated, then
* the superiority of the antibody response (GMT). If this superiority was demonstrated, then
* the superiority of the seroprotection rate.

Or to demonstrate:

* the non-inferiority of the seroprotection rate (antibody titers \>= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate or NeisVac-C® as measured by serum bactericidal assay using baby rabbit complement (rSBA). If this non-inferiority was demonstrated, then
* the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then
* the superiority of the antibody response (GMT).

Secondary Objective:

To demonstrate:

* the non-inferiority of the seroprotection rate (antibody titers \>= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate vaccine or Nimenrix® as measured by rSBA. If this non-inferiority was demonstrated, then
* the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then
* the superiority of the antibody response (GMT).

Or to demonstrate:

* the non-inferiority of the seroprotection rate (antibody titers \>= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate vaccine or NeisVac-C® as measured by hSBA. If this non-inferiority was demonstrated, then
* the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then
* the superiority of the antibody response (GMT) .

Conditions

  • Meningococcal Immunisation (Healthy Volunteers)

Interventions

BIOLOGICAL

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

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

BIOLOGICAL

Meningococcal polysaccharide group A, C, W-135 and Y Conjugate vaccine

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

BIOLOGICAL

Meningococcal group C polysaccharide Conjugate vaccine adsorbed

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-12
Primary Completion
2020-10-14
Completion
2020-10-14
FDA Drug
Yes

Countries

  • Denmark
  • Finland
  • Germany

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 NCT03890367 on ClinicalTrials.gov