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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

566 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-07-31

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.

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Detailed Description

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Conditions

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Hepatitis B Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Modified Process Hepatitis B Vaccine

Group Type EXPERIMENTAL

Comparator: Modified process Hepatitis B Vaccine

Intervention Type BIOLOGICAL

Modified Process Hepatitis B 3 x 5-mcg regimen administered via intramuscular injection.

2

Recombivax HB™

Group Type ACTIVE_COMPARATOR

Comparator: RECOMBIVAX HB™

Intervention Type BIOLOGICAL

RECOMBIVAX HB™ 3 x 5-mcg regimen administered via intramuscular injection.

Interventions

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Comparator: RECOMBIVAX HB™

RECOMBIVAX HB™ 3 x 5-mcg regimen administered via intramuscular injection.

Intervention Type BIOLOGICAL

Comparator: Modified process Hepatitis B Vaccine

Modified Process Hepatitis B 3 x 5-mcg regimen administered via intramuscular injection.

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

1 Day

Maximum Eligible Age

10 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes