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

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2001
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.
Epistemonikos ID: 0b80ef6dd8e197240be4983d8b39c832e6bf5c7d
First added on: Mar 23, 2020