A Study to Test the Safety and Effectiveness of an Investigational Vaccine in Infants (V419-002)

Phase 2 Completed 708 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of 4 different formulations of the HR5I vaccine (Haemophilus influenzae type b conjugate, recombinant hepatitis B surface antigen, diphtheria, tetanus, 5-component acellular pertussis, and inactivated poliovirus Types 1, 2, and 3). The primary hypothesis is that at least 1 of the 4 formulations of HR5I administered as a primary series at 2, 3, and 4 months of age will be acceptable (similar to targeted rates) with respect to Postdose 3 antibody responses to all antigens.

Timeline

Start: 2001-05
Primary completion: 2003-03
Completion: 2003-03

Publications

Results Halperin SA, Tapiero B, Diaz-Mitoma F, Law BJ, Hoffenbach A, Zappacosta PS, Radley D, McCarson BJ, Martin JC, Brackett LE, Boslego JW, Hesley TM, Bhuyan PK, Silber JL. Safety and immunogenicity of a hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine at 2, 3, 4, and 12-14 months of age. Vaccine. 2009 Apr 28;27(19):2540-7. doi: 10.1016/j.vaccine.2008.11.115. Epub 2009 Jan 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AR51 (12, 10)	Unknown	0.5 ml	Intramuscular
Subject	PR51 (3, 10)	Vaccine	0.5 ml	Intramuscular
Subject	PR51 (6, 10)	Vaccine	0.5 ml	Intramuscular
Subject	PR51 (6, 15)	Vaccine	0.5 ml	Intramuscular

Indications

No indication recorded.