# Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

> **NCT03691610** · PHASE3 · COMPLETED · sponsor: **Sanofi Pasteur, a Sanofi Company** · enrollment: 950 (actual)

## Conditions studied

- Healthy Volunteers (Meningococcal Infection)

## Interventions

- **BIOLOGICAL:** Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine
- **BIOLOGICAL:** Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
- **BIOLOGICAL:** Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine
- **BIOLOGICAL:** Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine
- **BIOLOGICAL:** Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine
- **BIOLOGICAL:** Haemophilus b Conjugate Vaccine
- **BIOLOGICAL:** Pneumococcal 13-valent Conjugate Vaccine
- **BIOLOGICAL:** Rotavirus Vaccine, Live, Oral, Pentavalent
- **BIOLOGICAL:** Hepatitis B Vaccine
- **BIOLOGICAL:** Measles, Mumps, and Rubella Virus Vaccine Live
- **BIOLOGICAL:** Varicella Virus Vaccine Live

## Key facts

- **NCT ID:** NCT03691610
- **Lead sponsor:** Sanofi Pasteur, a Sanofi Company
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2018-10-04
- **Primary completion:** 2023-10-20
- **Final completion:** 2023-10-20
- **Target enrollment:** 950 (ACTUAL)
- **Last updated:** 2024-06-25


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03691610

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03691610, "Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers". Retrieved via AI Analytics 2026-06-09 from https://api.ai-analytics.org/clinical/NCT03691610. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*