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

Study Overview
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Brief Summary
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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.

Official Title
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A Study in Healthy Neonates of Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured Using a Modified Process

Conditions
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Hepatitis B, Hepatocellular Carcinoma

Intervention / Treatment
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* Biological: Comparator: RECOMBIVAX HB™
* Biological: Comparator: Modified process Hepatitis B Vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 10 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Modified Process Hepatitis B Vaccine | Biological: Comparator: Modified process Hepatitis B Vaccine<br>* Modified Process Hepatitis B 3 x 5-mcg regimen administered via intramuscular injection.<br>|
| Active Comparator: 2<br>Recombivax HB™ | Biological: Comparator: RECOMBIVAX HB™<br>* RECOMBIVAX HB™ 3 x 5-mcg regimen administered via intramuscular injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean titer to hepatitis B surface antigen at Month 7 |  | 4 weeks Post Dose 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability including use of Vaccination Report Card |  | Follow-up 14 days Post Vaccination 1, 2, & 3 (Via Vaccination Report Card) |