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Trial record 1 of 7 for:    Recombivax HB | Hepatitis B | Phase 3
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A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)

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: NCT00414050
Recruitment Status : Completed
First Posted : December 21, 2006
Results First Posted : April 14, 2009
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Tracking Information
First Submitted Date  ICMJE December 20, 2006
First Posted Date  ICMJE December 21, 2006
Results First Submitted Date  ICMJE October 15, 2008
Results First Posted Date  ICMJE April 14, 2009
Last Update Posted Date May 23, 2017
Actual Study Start Date  ICMJE October 6, 2006
Actual Primary Completion Date October 22, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2017)
The Percentage of Seroresponders to the Modified Process Hepatitis B Vaccine (5 μg and 10 μg Dose), RECOMBIVAX HB™ Hepatitis B Vaccine (Currently Licensed Vaccine), and ENGERIX-B® [ Time Frame: 7 months of age (1 month after 3 doses) ]
The percentage of participants as measured by Seroresponse. Seroresponse was defined as anti-hepatitis B surface antibodies greater than or equal to 10 milli-International Units (mIU)/mL. Success on the primary immunogenicity hypothesis required demonstrating an adequate anti-HBs seroprotection rate response for either modified process hepatitis B 5 μg vaccine or RECOMBIVAX HB™. Specifically, the lower bound of the multiplicity adjusted 95% confidence interval (CI) on the seroprotection rate for either vaccine was required to be above 90.0%.
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2006)
Seroprotective rates (SPR) at one month after the third dose of vaccine
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2017)
Antibody to Hepatitis B Surface Antigen Geometric Mean Titer (Anti-HBs GMT) Responses for Modified Process Vaccine (5 μg and 10 μg), RECOMBIVAX™ Hepatitis B (Currently Licensed Vaccine), and ENGERIX-B® [ Time Frame: 7 months of age (1 month after 3 doses) ]
Geometric Mean Titer - Antibody titer is a laboratory test that measures the presence and amount of antibodies in blood.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2006)
Geometric mean titers (GMT) at one month after third dose of vaccine; safety and tolerability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)
Official Title  ICMJE A Study to Assess the Safety, Tolerability, and Immunogenicity of 2 Antigen Doses of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process Administered to Healthy Infants at 2, 4, and 6 Months of Age
Brief Summary This study was conducted in healthy infants and will provide new immunogenicity and safety data for the modified process hepatitis B vaccine. This study was conducted to address the following: to evaluate the immunogenicity and safety data of the 5 microgram dose of the modified process hepatitis B vaccine compared with a 10 microgram dose of the modified process hepatitis B vaccine, to evaluate another dosing schedule of 2, 4, and 6 months, and to provide descriptive immunogenicity data of another marketed vaccine (ENGERIX-B®).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Hepatitis B
Intervention  ICMJE
  • Biological: Modified Process Hepatitis B Vaccine (Experimental)
    Modified Process Hepatitis B Vaccine given intramuscularly (IM) in 3 injections of 5 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 5 μg arm). Modified Process Hepatitis B Vaccine given IM in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 10 μg arm).
  • Biological: Hepatitis B Vaccine (Recombinant)
    RECOMBIVAX HB™ (currently licensed product) given IM in 3 Injections of 5 ug/0.5 mL each over 4 months.
    Other Name: RECOMBIVAX HB™
  • Biological: Hepatitis B Vaccine (Recombinant)
    ENGERIX-B® (currently licensed product) given IM in 3 Injections of 10 ug/0.5 mL each over 4 months
    Other Name: ENGERIX-B®
Study Arms  ICMJE
  • Experimental: Modified Process Hepatitis B vaccine 5 μg
    Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
    Intervention: Biological: Modified Process Hepatitis B Vaccine (Experimental)
  • Active Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine
    Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
    Intervention: Biological: Hepatitis B Vaccine (Recombinant)
  • Experimental: Modified Process Hepatitis B vaccine 10 μg
    Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
    Intervention: Biological: Modified Process Hepatitis B Vaccine (Experimental)
  • Active Comparator: ENGERIX-B®
    Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
    Intervention: Biological: Hepatitis B Vaccine (Recombinant)
Publications * Vesikari T, Martin JC, Liss CL, Liska V, Schödel FP, Bhuyan PK. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy infants. Pediatr Infect Dis J. 2011 Jul;30(7):e109-13. doi: 10.1097/INF.0b013e31821ed1a4.

*   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: March 10, 2009)
1718
Original Enrollment  ICMJE
 (submitted: December 20, 2006)
1700
Actual Study Completion Date  ICMJE October 24, 2007
Actual Primary Completion Date October 22, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant is a healthy infant approximately 2 months of age

Exclusion Criteria:

  • Birth mother is a known carrier of hepatitis B virus or another known carrier has lived in close contact with the participant
  • Participant's birth mother did not receive any prenatal care
  • Participant has previous history of hepatitis B infection
  • Participant has been vaccinated against hepatitis B or birth mother was vaccinated within 6 months before birth of participant
  • Participant has had a fever within 72 hours of study start
  • Participant has received any blood-derived product or birth mother received blood-derived product within 6 months of birth of participant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 2 Months   (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 Finland,   Norway
 
Administrative Information
NCT Number  ICMJE NCT00414050
Other Study ID Numbers  ICMJE V232-057
2006_053
2006-001638-42 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Current Responsible Party Merck Sharp & Dohme LLC
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Merck Sharp & Dohme LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme LLC
PRS Account Merck Sharp & Dohme LLC
Verification Date April 2017

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