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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00322361

Enrollment

566

Registered

2006-05-05

Start date

2006-05-31

Completion date

2007-07-31

Last updated

2017-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Hepatocellular Carcinoma

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.

Interventions

BIOLOGICALComparator: RECOMBIVAX HB™

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

BIOLOGICALComparator: Modified process Hepatitis B Vaccine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Days to 10 Days

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026