Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,528

Participants

Timeline

Start Date

March 27, 2023

Primary Completion Date

December 2, 2025

Study Completion Date

December 2, 2025

Conditions
Meningococcal ImmunisationHealthy Volunteers
Interventions
BIOLOGICAL

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

Liquid solution - intramuscular

BIOLOGICAL

Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Liquid solution - intramuscular

BIOLOGICAL

Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV)

Oral suspension - oral

BIOLOGICAL

Pneumoccocal Vaccine

Suspension for injection - intramuscular

BIOLOGICAL

Measles, Mumps, and Rubella Vaccine live (MMR)

Lyophilized powder for injection - subcutaneous

BIOLOGICAL

DTwP-HepB-Hib-IPV vaccine

Suspension - intramuscular

BIOLOGICAL

DTaP-IPV-Hib-HepB vaccine

Liquid solution - intramuscular

BIOLOGICAL

Hepatitis A vaccine

Lyophilized powder for injection - subcutaneous

BIOLOGICAL

Rotavirus vaccine

Oral solution - oral

BIOLOGICAL

Typhoid conjugate vaccine (TCV)

Suspension for injection - intramuscular

BIOLOGICAL

Measles vaccine

Freeze-dried powder for reconstitution and injection - subcutaneous

BIOLOGICAL

Varicella vaccine live

Sterile powder and diluent for injection - subcutaneous

BIOLOGICAL

Varicella vaccine live

Lyophilized powder for injection - subcutaneous

BIOLOGICAL

Measles, Mumps, and Rubella Vaccine live (MMR)

Lyophilized powder for injection - subcutaneous

BIOLOGICAL

Hepatitis A vaccine

Suspension for injection - intramuscular

Trial Locations (15)

1055

Investigational Site Number : 7100001, Middelburg

2013

Investigational Site Number : 7100005, Johannesburg

6530

Investigational Site Number : 7100006, George

7505

Investigational Site Number : 7100002, Cape Town

7937

Investigational Site Number : 7100003, Cape Town

110002

Investigational Site Number : 3560003, New Delhi

208002

Investigational Site Number : 3560016, Kanpur

411011

Investigational Site Number : 3560002, Pune

411043

Investigational Site Number : 3560001, Pune

500018

Investigational Site Number : 3560007, Hyderabad

570001

Investigational Site Number : 3560013, Mysore

570004

Investigational Site Number : 3560004, Mysore

576104

Investigational Site Number : 3560011, Manipal

603203

Investigational Site Number : 3560006, Chennai

700017

Investigational Site Number : 3560009, Kolkata

All Listed Sponsors
lead

Sanofi Pasteur, a Sanofi Company

INDUSTRY