Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico

PHASE3CompletedINTERVENTIONAL
Enrollment

525

Participants

Timeline

Start Date

October 17, 2018

Primary Completion Date

February 18, 2022

Study Completion Date

February 18, 2022

Conditions
Healthy Volunteers (Meningococcal Infection)
Interventions
BIOLOGICAL

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

Pharmaceutical form: Liquid solution Route of administration : Intramuscular

BIOLOGICAL

Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine

Pharmaceutical form: Lyophilized powder combined with liquid component Route of administration : Intramuscular

BIOLOGICAL

Measles, Mumps, and Rubella Virus Vaccine Live

Pharmaceutical form: Lyophilized live virus vaccine Route of administration : Subcutaneous

BIOLOGICAL

Pneumococcal 13-valent Conjugate Vaccine

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine

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

BIOLOGICAL

Hepatitis B Vaccine

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

Rotavirus Vaccine, Live, Pentavalent

Pharmaceutical form: Oral solution Route of administration: Oral

BIOLOGICAL

Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

Trial Locations (11)

39670

Investigational Site Number :4840001, Acapulco de Juárez

62770

Investigational Site Number :4840003, Tlaltizapán

188300

Investigational Site Number :6431018, Gatchina

191025

Investigational Site Number :6431007, Saint Petersburg

196084

Investigational Site Number :6431010, Saint Petersburg

197022

Investigational Site Number :6431001, Saint Petersburg

350015

Investigational Site Number :6431008, Krasnodar

443079

Investigational Site Number :6431006, Samara

614066

Investigational Site Number :6431004, Perm

620028

Investigational Site Number :6431002, Yekaterinburg

04530

Investigational Site Number :4840002, Mexico City

All Listed Sponsors
lead

Sanofi Pasteur, a Sanofi Company

INDUSTRY

NCT03630705 - Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico | Biotech Hunter | Biotech Hunter