A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)

Phase 3 Completed 2808 enrolled Merck Sharp & Dohme LLC MCM Vaccines B.V. · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

This study will determine whether three manufacturing lots of V419 (PR5I) induce similar immune responses to all of the antigens contained in V419 when given concomitantly with Prevnar13™ and RotaTeq™.

Timeline

Start: 2011-05-10
Primary completion: 2012-12-18
Completion: 2013-07-26

Outcome

Mixed primary results

paper Immunogenicity of HV was noninferior to Control for all antibodies PMID 27846058 ↗

paper except for pertussis filamentous hemagglutinin geometric mean concentration postdose 3 PMID 27846058 ↗

registry Control vs V419 Lots A, B, and C Combined; p = 0.419; GMC Ratio (Combined/Control) 0.67 (95% CI 0.62 to 0.73); ANCOVA NCT01340937 ↗

Publications

Results Block SL, Klein NP, Sarpong K, Russell S, Fling J, Petrecz M, Flores S, Xu J, Liu G, Stek JE, Foglia G, Lee AW. Lot-to-lot Consistency, Safety, Tolerability and Immunogenicity of an Investigational Hexavalent Vaccine in US Infants. Pediatr Infect Dis J. 2017 Feb;36(2):202-208. doi: 10.1097/INF.0000000000001405.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pentacel	Vaccine	0.5 ml	Intramuscular
Subject	Prevnar 13	Vaccine	0.5 ml	Intramuscular
Subject	V419	Vaccine	0.5 ml	Intramuscular
Comparator	HEPLISAV-B	Vaccine	0.5 ml	Intramuscular
Background	RotaTeq	Vaccine	2 ml	Oral