Status:
COMPLETED
A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis B
Eligibility:
All Genders
2-2 years
Phase:
PHASE3
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 eval...
Eligibility Criteria
Inclusion
- Participant is a healthy infant approximately 2 months of age
Exclusion
- 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
Key Trial Info
Start Date :
October 6 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2007
Estimated Enrollment :
1718 Patients enrolled
Trial Details
Trial ID
NCT00414050
Start Date
October 6 2006
End Date
October 24 2007
Last Update
May 23 2017
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