Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005)

Phase 3 Completed 1473 enrolled Merck Sharp & Dohme LLC MCM Vaccines B.V. · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

This is a study to assess the safety, tolerability, and immunogenicity of V419 (PR5I) when administered as an infant series at 2, 4, and 6 months of age followed by a toddler dose of DAPTACEL™, Prevnar 13™ and PedvaxHIB™ at 15 months of age. The study will determine whether subjects who receive V419 have a similar immune response to the vaccine compared to subjects who receive licensed component vaccine controls.

Timeline

Start: 2011-04-19
Primary completion: 2013-05-09
Completion: 2013-05-09

Publications

Background Marshall GS, Adams GL, Leonardi ML, Petrecz M, Flores SA, Ngai AL, Xu J, Liu G, Stek JE, Foglia G, Lee AW. Immunogenicity, Safety, and Tolerability of a Hexavalent Vaccine in Infants. Pediatrics. 2015 Aug;136(2):e323-32. doi: 10.1542/peds.2014-4102.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	ActHIB	Vaccine	0.5 ml	Intramuscular
Subject	HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN	Vaccine	0.5 ml	Intramuscular
Comparator	HEPLISAV-B	Vaccine	0.5 ml	Intramuscular
Comparator	Pentacel	Vaccine	0.5 ml	Intramuscular
Subject	V419	Vaccine	0.5 ml	Intramuscular
Background	Adacel	Vaccine	0.5 ml	Intramuscular
Background	Prevnar 13	Vaccine	0.5 ml	Intramuscular
Background	Rotarix	Vaccine	2 ml	Oral

Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005)

Summary

Timeline

Publications

Drugs

Indications