Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056)

Phase 2

Completed

• Conditions: Hepatocellular Carcinoma; Hepatitis B

• Registration Number: NCT00322361
• Lead Sponsor: Merck Sharp & Dohme LLC

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 the morbidity and mortality of acute hepatitis B virus infection, \[2\] reduce the incidence of chronic infection in vaccinated populations, and \[3\] thereby, reduce the incidence of hepatocellular carcinoma. The purpose of the trial is to assess if the new manufacturing process of the Hepatitis B Vaccine \[Recombinant\] vaccine shows the same level of hepatitis B antibody response or better as the currently licensed Hepatitis B Vaccine \[Recombinant\] vaccine. This study will also confirm that the new process vaccine is as well tolerated as the current vaccine.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-02
• Study First Submitted QC: 2006-05-04
• Study First Posted: 2006-05-05
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-15
• Last Update Posted: 2017-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 566

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Geometric mean titer to hepatitis B surface antigen at Month 7	4 weeks Post Dose 3

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability including use of Vaccination Report Card	Follow-up 14 days Post Vaccination 1, 2, & 3 (Via Vaccination Report Card)