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

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

Outcome

Mixed primary results

registry analysis (non-inferiority or equivalence test); V419 vs Control; p <0.001; Response Rate Difference (V419 - Ctrl) 9.68 (95% CI 4.83 to 14.83) NCT01337167 ↗

registry analysis (non-inferiority or equivalence test); V419 vs Control; p = 0.786; GMC Ratio (V419/Control) 0.64 (95% CI 0.59 to 0.70) NCT01337167 ↗

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	DAPTACEL®	Vaccine	0.5 ml	Intramuscular
Background	Prevnar 13	Vaccine	0.5 ml	Intramuscular
Background	RotaTeq	Vaccine	2 ml	Oral

Indications