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

Phase 3 Completed 2627 enrolled Sanofi Pasteur, a Sanofi Company

RandomizedParallel-groupQuadruple-blindPrevention

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

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	Havrix	Vaccine	—	—
Subject	Hepatitis B vaccine	Vaccine	—	Intramuscular
Subject	M-M-R II	Vaccine	—	Subcutaneous
Subject	MenACYW conjugate vaccine	Vaccine	0.5 ml	Intramuscular
Comparator	Menveo	Vaccine	0.5 ml	Intramuscular
Subject	Prevnar 13	Vaccine	—	Intramuscular
Subject	Rotarix	Vaccine	—	Oral
Subject	Varicella vaccine	Vaccine	—	—

Indications

No indication recorded.