A Study of the Safety and Tolerability of V419 in Healthy Infants at 2,4, 6 and 12 to 14 Months of Age (V419-003)

NCT00551915 ↗

Phase 2 Completed 756 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of 3 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 3 formulations of HR5I administered as a primary series at 2, 4, and 6 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: 2003-01
Completion: 2003-01

Publications

Results Diaz-Mitoma F, Halperin SA, Tapiero B, Hoffenbach A, Zappacosta PS, Radley D, Bradshaw S, Martin JC, Boslego JW, Hesley TM, Bhuyan PK, Silber JL. Safety and immunogenicity of three different formulations of a liquid hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine at 2, 4, 6 and 12-14 months of age. Vaccine. 2011 Feb 1;29(6):1324-31. doi: 10.1016/j.vaccine.2010.11.053. Epub 2010 Dec 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AR51	Unknown	12 ug	Intramuscular
Subject	AR51 (12, 10)	Unknown	0.5 ml	Intramuscular
Comparator	HEPLISAV-B	Vaccine	0.5 ml	Intramuscular
Subject	PR51	Vaccine	3 ug	Intramuscular
Subject	PR51	Vaccine	6 ug	Intramuscular
Comparator	Pentacel	Vaccine	0.5 ml	Intramuscular

Indications

No indication recorded.