NCT04143061

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,328 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 12 Months
• Healthy volunteers: Accepted

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.

Detailed description

Study duration per participant is approximately 31 to 45 days

Conditions

• Meningococcal Immunization
• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-12-30
• Primary completion: 2023-01-28
• Completion: 2023-01-28
• First posted: 2019-10-29
• Last updated: 2025-02-03
• Results posted: 2025-02-03

Locations

17 sites across 2 countries: India, South Africa

Regulatory

• FDA-regulated drug study