Bacterial Infections; Virus Diseases Clinical Trial
Official title:
Safety, Tolerability, and Immunogenicity of 3 Different Formulations of a Liquid Hexavalent Combination Vaccine, HR5I When Administered to Healthy Hepatitis B Vaccine-Naive Infants at 2, 4, 6, and 12-14 Months of Age
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.
Participants will be randomized into 4 arms:
AR51 (12, 10): arm receiving vaccine formulation containing 12 mcg of polyribosylribitol
phosphate (PRP) conjugated to tetanus toxoid (PRP-T) and 10 mcg of Hepatitis B surface
antigen (HBsAg)
PR51 (3, 10): arm receiving vaccine formulation containing 3 mcg of polyribosylribitol
phosphate conjugated to the outer membrane protein complex of Neisseria meningitides
(PRP-OMPC) and 10 mcg of HBsAg
PR51 (6, 10): arm receiving vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of
HBsAg
PENTACEL™ + RECOMBIVAX HB™: open-label control group receiving PENTACEL™ (licensed vaccine
for diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus
influenzae type b) and RECOMBIVAX HB™ (licensed vaccine for hepatitis)
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00551629 -
A Study to Test the Safety and Effectiveness of an Investigational Vaccine in Infants (V419-002)
|
Phase 2 |