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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00322361
Recruitment Status : Completed
First Posted : May 5, 2006
Last Update Posted : March 16, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

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

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Study Type : Interventional  (Clinical Trial)
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 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Geometric mean titer to hepatitis B surface antigen at Month 7 [ Time Frame: 4 weeks Post Dose 3 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   1 Day to 10 Days   (Child)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00322361

Sponsors and Collaborators
Merck Sharp & Dohme LLC
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Study Director: Medical Monitor Merck Sharp & Dohme LLC
Additional Information:
Study Data/Documents: CSR Synopsis  This link exits the site

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme LLC Identifier: NCT00322361    
Other Study ID Numbers: V232-056
First Posted: May 5, 2006    Key Record Dates
Last Update Posted: March 16, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections