Modified Process Hepatitis B Vaccine in Healthy Neonates

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00322361
First received: May 2, 2006
Last updated: February 18, 2009
Last verified: February 2009

May 2, 2006
February 18, 2009
May 2006
July 2007   (final data collection date for primary outcome measure)
Geometric mean titer to hepatitis B surface antigen at Month 7 [ Time Frame: 4 weeks Post Dose 3 ] [ Designated as safety issue: No ]
Geometric mean titer to hepatitis B surface antigen at Month 7
Complete list of historical versions of study NCT00322361 on ClinicalTrials.gov Archive Site
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 ]
Safety and tolerability including use of Vaccination Report Card
Not Provided
Not Provided
 
Modified Process Hepatitis B Vaccine in Healthy Neonates
A Study in Healthy Neonates of Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured Using a Modified Process

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Hepatitis B
  • Hepatocellular Carcinoma
  • Biological: Comparator: RECOMBIVAX HB™
    RECOMBIVAX HB™ 3 x 5-mcg regimen administered via intramuscular injection.
  • Biological: Comparator: Modified process Hepatitis B Vaccine
    Modified Process Hepatitis B 3 x 5-mcg regimen administered via intramuscular injection.
  • Active Comparator: 1
    Recombivax HB™
    Intervention: Biological: Comparator: RECOMBIVAX HB™
  • Experimental: 2
    Modified Process Hepatitis B Vaccine
    Intervention: Biological: Comparator: Modified process Hepatitis B Vaccine
Minervini G, McCarson BJ, Reisinger KS, Martin JC, Stek JE, Atkins BM, Nadig KB, Liska V, Schödel FP, Bhuyan PK. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy neonates. Vaccine. 2012 Feb 14;30(8):1476-80. Epub 2012 Jan 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
566
August 2007
July 2007   (final data collection date for primary outcome measure)

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
Both
up to 10 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00322361
2006_007, V232-056
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP