Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)

Phase 3 Completed 1250 enrolled MCM Vaccines B.V. Merck Sharp & Dohme LLC · collab

RandomizedParallel-groupDouble-blindPrevention

Summary

This study will determine whether participants who receive the vaccine V419 at 2, 3, 4, and 12 months of age have an acceptable immune response to the vaccine. The study will also determine whether the immune response to V419 is similar to that of participants who receive a licensed vaccine control.

Timeline

Start: 2011-05-26
Primary completion: 2013-03-13
Completion: 2013-03-13

Outcome

Met primary endpoint

paper In a per-protocol analysis, immune responses to vaccine antigens 1 month after dose 3 and after the toddler dose were noninferior PMID 27846055 ↗

Publications

Vesikari T, Becker T, Vertruyen AF, Poschet K, Flores SA, Pagnoni MF, Xu J, Liu GF, Stek JE, Boisnard F, Thomas S, Ziani E, Lee AW. A Phase III Randomized, Double-blind, Clinical Trial of an Investigational Hexavalent Vaccine Given at Two, Three, Four and Twelve Months. Pediatr Infect Dis J. 2017 Feb;36(2):209-215. doi: 10.1097/INF.0000000000001406.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Infanrix hexa	Vaccine	0.5 ml	Intramuscular
Subject	ProQuad	Vaccine	0.5 ml	Subcutaneous
Subject	V419	Vaccine	0.5 ml	Intramuscular
Background	Prevenar 13	Vaccine	0.5 ml	Intramuscular
Background	RotaTeq	Vaccine	2 ml	Oral