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

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

Outcome

Mixed primary results

paper All PRP-OMPC formulations met prespecified acceptability criteria for postdose 3 immunogenicity for all antigens PMID 19124057 ↗

paper Apart from the Hib response, the postdose 3 responses obtained with the PRP-T formulation met the acceptability criterion for each antigen. PMID 19124057 ↗

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.