Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)

Phase 3 Completed 1315 enrolled MCM Vaccines B.V. Merck Sharp & Dohme LLC · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

This study will determine whether participants who receive V419 (PR5I) at 2, 4, and 11 to 12 months of age have an acceptable response to the vaccine. This study will also determine whether the immune response to V419 is similar to that of participants who received a licensed vaccine control. The primary hypothesis is that participants who receive PR5I at 2, 4, and 11 to 12 months have an acceptable response rate to all PR5I-contained antigens at one month after the Toddler dose of PR5I.

Timeline

Start: 2011-11-23
Primary completion: 2013-10-09
Completion: 2013-10-09

Outcome

Met primary endpoint

paper Immune responses to all vaccine antigens post-toddler dose were non-inferior in the DTaP5-HB-IPV-Hib Group as compared to the Control Group. PMID 27288217 ↗

Publications

Silfverdal SA, Icardi G, Vesikari T, 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 2, 4, and 11-12 months. Vaccine. 2016 Jul 19;34(33):3810-6. doi: 10.1016/j.vaccine.2016.05.054. Epub 2016 Jun 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Infanrix hexa	Vaccine	0.5 ml	Intramuscular
Subject	PR5I	Vaccine	0.5 ml	Intramuscular
Background	Prevenar 13	Vaccine	0.5 ml	Intramuscular
Background	RotaTeq	Vaccine	2 ml	Oral
Background	Rotarix	Vaccine	1.5 ml	Oral