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Modified Process Hepatitis B Vaccine in Healthy Neonates

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00322361
First received: May 2, 2006
Last updated: February 18, 2009
Last verified: February 2009
History of Changes
  Purpose

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 Intervention Phase
Hepatitis B
Hepatocellular Carcinoma
 Biological: Comparator: RECOMBIVAX HB™
Biological: Comparator: Modified process Hepatitis B Vaccine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Geometric mean titer to hepatitis B surface antigen at Month 7 [ Time Frame: 4 weeks Post Dose 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability including use of Vaccination Report Card [ Time Frame: Follow-up 14 days Post Vaccination 1, 2, & 3 (Via Vaccination Report Card) ] [ Designated as safety issue: Yes ]

Enrollment: 566
Study Start Date: May 2006
Study Completion Date: August 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Recombivax HB™
 Biological: Comparator: RECOMBIVAX HB™
RECOMBIVAX HB™ 3 x 5-mcg regimen administered via intramuscular injection.
Experimental: 2
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.

  Eligibility

Ages Eligible for Study:   up to 10 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00322361

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00322361     History of Changes
Other Study ID Numbers: 2006_007, V232-056
Study First Received: May 2, 2006
Last Updated: February 18, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Hepatitis
Hepatitis A
Hepatitis B
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on May 16, 2013