NCT03673462

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

A Randomized Study to Describe the Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,797 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 42 Days – 89 Days
• Healthy volunteers: Accepted

Summary

The primary objective of this study was to describe the safety profile of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate Vaccine and Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®) Conjugate Vaccine when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers.

Detailed description

Study duration per participant was approximately 16 months, which includes a safety follow-up contact at 6 months after the final vaccination.

Conditions

• Healthy Volunteers (Meningococcal Infection)

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine)	Pharmaceutical form: Liquid solution. Route of administration: Intramuscular
BIOLOGICAL	Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®)	Pharmaceutical form: Lyophilized powder combined with liquid components Route of administration: Intramuscular
BIOLOGICAL	Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine	Pharmaceutical form: Liquid DTaP-IPV to reconstitute lyophilized ActHIB Route of administration: Intramuscular
BIOLOGICAL	Pneumococcal 13-valent Conjugate Vaccine	Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
BIOLOGICAL	Rotavirus Vaccine	Pharmaceutical form: Oral solution Route of administration: Oral
BIOLOGICAL	Hepatitis B Vaccine	Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
BIOLOGICAL	Measles, Mumps, and Rubella Virus Vaccine	Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous
BIOLOGICAL	Varicella Virus Vaccine	Pharmaceutical form: Suspension for injection Route of administration: Subcutaneous

Timeline

• Start date: 2018-09-17
• Primary completion: 2023-03-16
• Completion: 2023-03-16
• First posted: 2018-09-17
• Last updated: 2023-12-14
• Results posted: 2023-10-05

Locations

69 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study