A Study to Assess the Safety, Tolerability, and Immunogenicity of 2 Antigen Doses of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process Administered to Healthy Infants at 2, 4, and 6 Months of Age
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hepatitis B
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 1718
- Primary Endpoint
- The Percentage of Seroresponders to the Modified Process Hepatitis B Vaccine (5 μg and 10 μg Dose), RECOMBIVAX HB™ Hepatitis B Vaccine (Currently Licensed Vaccine), and ENGERIX-B®
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This study was conducted in healthy infants and will provide new immunogenicity and safety data for the modified process hepatitis B vaccine. This study was conducted to address the following: to evaluate the immunogenicity and safety data of the 5 microgram dose of the modified process hepatitis B vaccine compared with a 10 microgram dose of the modified process hepatitis B vaccine, to evaluate another dosing schedule of 2, 4, and 6 months, and to provide descriptive immunogenicity data of another marketed vaccine (ENGERIX-B®).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant is a healthy infant approximately 2 months of age
Exclusion Criteria
- •Birth mother is a known carrier of hepatitis B virus or another known carrier has lived in close contact with the participant
- •Participant's birth mother did not receive any prenatal care
- •Participant has previous history of hepatitis B infection
- •Participant has been vaccinated against hepatitis B or birth mother was vaccinated within 6 months before birth of participant
- •Participant has had a fever within 72 hours of study start
- •Participant has received any blood-derived product or birth mother received blood-derived product within 6 months of birth of participant
Outcomes
Primary Outcomes
The Percentage of Seroresponders to the Modified Process Hepatitis B Vaccine (5 μg and 10 μg Dose), RECOMBIVAX HB™ Hepatitis B Vaccine (Currently Licensed Vaccine), and ENGERIX-B®
Time Frame: 7 months of age (1 month after 3 doses)
The percentage of participants as measured by Seroresponse. Seroresponse was defined as anti-hepatitis B surface antibodies greater than or equal to 10 milli-International Units (mIU)/mL. Success on the primary immunogenicity hypothesis required demonstrating an adequate anti-HBs seroprotection rate response for either modified process hepatitis B 5 μg vaccine or RECOMBIVAX HB™. Specifically, the lower bound of the multiplicity adjusted 95% confidence interval (CI) on the seroprotection rate for either vaccine was required to be above 90.0%.
Secondary Outcomes
- Antibody to Hepatitis B Surface Antigen Geometric Mean Titer (Anti-HBs GMT) Responses for Modified Process Vaccine (5 μg and 10 μg), RECOMBIVAX™ Hepatitis B (Currently Licensed Vaccine), and ENGERIX-B®(7 months of age (1 month after 3 doses))