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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.
 
ClinicalTrials.gov Identifier: NCT00322361
Recruitment Status : Completed
First Posted : May 5, 2006
Last Update Posted : March 16, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE May 2, 2006
First Posted Date  ICMJE May 5, 2006
Last Update Posted Date March 16, 2017
Study Start Date  ICMJE May 2006
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2009)
Geometric mean titer to hepatitis B surface antigen at Month 7 [ Time Frame: 4 weeks Post Dose 3 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2006)
Geometric mean titer to hepatitis B surface antigen at Month 7
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2009)
Safety and tolerability including use of Vaccination Report Card [ Time Frame: Follow-up 14 days Post Vaccination 1, 2, & 3 (Via Vaccination Report Card) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2006)
Safety and tolerability including use of Vaccination Report Card
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056)
Official Title  ICMJE A Study in Healthy Neonates of Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured Using a Modified Process
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Hepatitis B
  • Hepatocellular Carcinoma
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: 1
    Modified Process Hepatitis B Vaccine
    Intervention: Biological: Comparator: Modified process Hepatitis B Vaccine
  • Active Comparator: 2
    Recombivax HB™
    Intervention: Biological: Comparator: RECOMBIVAX HB™
Publications * 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. doi: 10.1016/j.vaccine.2011.12.095. Epub 2012 Jan 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2009)
566
Original Enrollment  ICMJE
 (submitted: May 4, 2006)
560
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 10 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Puerto Rico,   United States
 
Administrative Information
NCT Number  ICMJE NCT00322361
Other Study ID Numbers  ICMJE V232-056
2006_007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date March 2017

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