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Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adults, Adolescents, Children, and Toddlers in India and Healthy Adolescents and Children in the Republic of South Africa

NCT04143061 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1328

Last updated 2025-02-03

Study results available
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Summary

This will be a Phase III, modified double-blind (open-label for toddlers in India), randomized, parallel-group, active-controlled, step-wise, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adults, adolescents, children, and toddlers in India and a modified double-blind, randomized, parallel-group, active-controlled, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adolescents and children in RSA.

Conditions

  • Meningococcal Immunization
  • Healthy Volunteers

Interventions

BIOLOGICAL

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

Pharmaceutical form: solution for injection; Route of administration: intramuscular, 0.5 mL

BIOLOGICAL

Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine

Pharmaceutical form: sterile aqueous solution; Route of administration: intramuscular, 0.5 mL

BIOLOGICAL

Meningococcal polysaccharide (serogroups A, C, Y and W-135) vaccine

Pharmaceutical form: reconstituted solution for injection; Route of administration: intramuscular, 0.5 mL

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
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-30
Primary Completion
2023-01-28
Completion
2023-01-28
FDA Drug
Yes

Countries

  • India
  • South Africa

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 NCT04143061 on ClinicalTrials.gov