Interchangeability of Infanrix™ IPV/Hib and Pediacel® at 2,4 & 6 Months of Age

Phase 3 Completed 253 enrolled Dalhousie University IWK Health Centre · collab MCM Vaccines B.V. · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

To demonstrate the safety and immunogenicity of two mixed primary immunization schedules: Pediacel® at 2 and 4 months of age followed by one dose of Infanrix™ IPV/Hib at 6 months of age; and, Infanrix™ IPV/Hib at 2 months of age, followed by Pediacel® at 4 and 6 months of age.

Timeline

Start: 2010-05
Primary completion: 2010-07
Completion: 2011-01

Publications

Langley JM, Halperin SA, Rubin E, White C, McNeil S, Mutch J, Mackinnon-Cameron D, Smith B. Safety and immunogenicity of 2 mixed primary infant immunization schedules of pentavalent diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, and Haemophilus influenzae Type B vaccines at 2, 4, and 6 months of age: a randomized controlled trial. Pediatr Infect Dis J. 2012 Feb;31(2):189-92. doi: 10.1097/INF.0b013e318242462a.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Adacel	Vaccine	0.5 ml	Intramuscular
Comparator	Pediacel®	Vaccine	0.5 ml	Intramuscular

Indications

No indication recorded.