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

Summary

The purpose of this study was to compare the immunogenicity and describe the safety of MenACYW conjugate vaccine and MENVEO® when both are administered concomitantly with routine pediatric vaccines to healthy infants and toddlers in the US.

Timeline

Start

2018-04-25

Primary completion

2023-09-22

Completion

2023-09-22

Outcome

Met primary endpoint

paper Non-inferiority was demonstrated for the first co-primary endpoint PMID 41337697 ↗

paper Non-inferiority was also demonstrated for the second co-primary endpoint PMID 41337697 ↗

Publications

• Campbell JD, Gupta S, Dhingra MS, Zambrano B, Gan L, B'Chir S, Chaix J, Syrkina O, Masson J, Liabis O, Rehm C. A Phase 3 study to assess the safety and immunogenicity of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) co-administered with routine pediatric vaccines in healthy infants in the USA and Puerto Rico. Hum Vaccin Immunother. 2025 Dec;21(1):2588874. doi: 10.1080/21645515.2025.2588874. Epub 2025 Dec 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DTaP-IPV//Hib vaccine	Vaccine	—	Intramuscular
Subject	Hepatitis A vaccine	Vaccine	—	—
Subject	Hepatitis B vaccine	Vaccine	—	Intramuscular
Subject	MenACYW conjugate vaccine	Vaccine	0.5 ml	Intramuscular
Comparator	MenACYW-135 conjugate vaccine	Unknown	0.5 ml	Intramuscular
Subject	Pentavalent rotavirus vaccine	Vaccine	—	Oral
Subject	Pneumococcal 13-valent Conjugate Vaccine	Vaccine	—	Intramuscular
Subject	Varicella vaccine	Vaccine	—	—
Subject	measles-mumps-rubella (MMR) vaccine	Vaccine	—	Subcutaneous

Indications

No indication recorded.