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

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00322361
Collaborator
(none)
566
Enrollment
2
Arms
14
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Comparator: RECOMBIVAX HB™
  • Biological: Comparator: Modified process Hepatitis B Vaccine
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
566 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
A Study in Healthy Neonates of Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured Using a Modified Process
Study Start Date :
May 1, 2006
Actual Primary Completion Date :
Jul 1, 2007
Actual Study Completion Date :
Jul 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Modified Process Hepatitis B Vaccine

Biological: Comparator: Modified process Hepatitis B Vaccine
Modified Process Hepatitis B 3 x 5-mcg regimen administered via intramuscular injection.
Active Comparator: 2

Recombivax HB™

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

Outcome Measures

Primary Outcome Measures

  1. Geometric mean titer to hepatitis B surface antigen at Month 7 [4 weeks Post Dose 3]

Secondary Outcome Measures

  1. Safety and tolerability including use of Vaccination Report Card [Follow-up 14 days Post Vaccination 1, 2, & 3 (Via Vaccination Report Card)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Day to 10 Days
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:
NCT00322361
Other Study ID Numbers:
  • V232-056
  • 2006_007
First Posted:
May 5, 2006
Last Update Posted:
Mar 16, 2017
Last Verified:
Mar 1, 2017
Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Hepatitis

Study Results

No Results Posted as of Mar 16, 2017