Status:
COMPLETED
Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis B
Hepatocellular Carcinoma
Eligibility:
All Genders
1-10 years
Phase:
PHASE2
Brief Summary
Hepatitis B Vaccine \[Recombinant\] is a well-established vaccine which has been used extensively, worldwide since its initial licensure in 1986. Hepatitis B vaccines: \[1\] induce protection against ...
Eligibility Criteria
Inclusion
- Healthy male and female full-term (37-42 weeks gestation) neonates (birth to 10 days of age)
- Born to mothers with documented negative test for HBsAg within 9 months prior to delivery
Exclusion
- Infant born to mother with no prenatal care
- Known or suspected impairment of immunologic function
- Prior vaccination with any hepatitis B vaccine for infant or mother(within 6 months prior to the birth of infant.)
- Recent(\<72 hours) history of febrile illness \>/= 99.5 degrees F (\>/= 37.5 degrees C) axillary or \>/= 100.5 degrees F (\>/= 38.1 degrees C) rectal
- Any prior administration of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product, or the receipt by the mother of either immunoglobulin or HBIG within 6 months prior to birth of the infant
- Receipt of investigational vaccines by mother or infant within 3 months prior to first injection with study vaccine or if scheduled to be given to the infant during the study
- Known or suspected hypersensitivity to any component of study vaccine (e.g., aluminum, yeast)
- Any infant who cannot be adequately followed for study visits during the course of the clinical study
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
566 Patients enrolled
Trial Details
Trial ID
NCT00322361
Start Date
May 1 2006
End Date
July 1 2007
Last Update
March 16 2017
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