Phase 3
Completed N=1,718
A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)
Source: ClinicalTrials.gov NCT00414050 ↗Enrolled (actual)
1,718
Serious AEs
1.6%
Results posted
Apr 2009
Primary outcomePrimary: 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® — 99.3; 98.5; 100; 99.5 Percentage of participants
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®).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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® |
99.3; 98.5; 100; 99.5 | — |
| SECONDARY 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® |
748.2; 376.8; 981.5; 556.6 | — |
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
Data sourced from ClinicalTrials.gov (NCT00414050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.