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Modified Process Hepatitis B Vaccine in Healthy Neonates

This study has been completed.
Information provided by:
Merck Sharp & Dohme Corp. Identifier:
First received: May 2, 2006
Last updated: February 18, 2009
Last verified: February 2009

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:

Further study details as provided by Merck Sharp & Dohme Corp.:

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.


Ages Eligible for Study:   up to 10 Days
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00322361

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. 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, Hepatocellular
Hepatitis A
Hepatitis B
DNA Virus Infections
Digestive System Diseases
Digestive System Neoplasms
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Liver Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Picornaviridae Infections
RNA Virus Infections
Virus Diseases processed this record on November 24, 2014