Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 7 for:    Recombivax HB | Hepatitis B | Phase 3

Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)

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: NCT00440531
Recruitment Status : Completed
First Posted : February 27, 2007
Results First Posted : March 31, 2009
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Tracking Information
First Submitted Date  ICMJE February 26, 2007
First Posted Date  ICMJE February 27, 2007
Results First Submitted Date  ICMJE November 11, 2008
Results First Posted Date  ICMJE March 31, 2009
Last Update Posted Date April 13, 2017
Study Start Date  ICMJE November 2006
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2009)
The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine) [ Time Frame: 7 months (1 month after third vaccination) ]
The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination).
Original Primary Outcome Measures  ICMJE
 (submitted: February 26, 2007)
Seroprotective rates (SPR) to Hepatitis B one month after the third dose
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2009)
  • The Number of Seroresponders to ENGERIX-B™ (Currently Licensed Vaccine) [ Time Frame: 7 months (1 month after third vaccination) ]
    The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination).
  • The Total Number of Participants With One or More Injection-site Adverse Experiences [ Time Frame: Days 1-5 After Any Vaccination ]
  • The Total Number of Participants With a Maximum Temperature >=100.0F/37.8C [ Time Frame: Day 1-5 After Vaccination ]
  • The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences [ Time Frame: During Entire Study Period (from first vaccination until the participant completes or discontinues: up to 7 months) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2007)
Safety and tolerability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)
Official Title  ICMJE A Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process
Brief Summary The purpose of this trial is to determine if there is an improvement in the immune response of older adults over 50 years of age using a modified process hepatitis B vaccine and a currently licensed hepatitis B vaccine (RECOMBIVAX HB™).
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: Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant)
    RECOMBIVAX HB™ (currently licensed product) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.
  • Biological: Comparator: Modified Process Hepatitis B Vaccine (Experimental)
    Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.
  • Biological: Comparator: ENGERIX-B™ (currently licensed product)
    ENGERIX-B™ given IM (Intramuscular) in 3 doses of 20 mcg (micrograms)/1.0 mL each over 6 months.
Study Arms  ICMJE
  • Active Comparator: 1
    RECOMBIVAX HB™
    Intervention: Biological: Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant)
  • Experimental: 2
    Modified Process Hepatitis B Vaccine
    Intervention: Biological: Comparator: Modified Process Hepatitis B Vaccine (Experimental)
  • Active Comparator: 3
    ENGERIX-B™
    Intervention: Biological: Comparator: ENGERIX-B™ (currently licensed product)
Publications * Gilbert CL, Klopfer SO, Martin JC, Schödel FP, Bhuyan PK. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy adults ≥50 years. Hum Vaccin. 2011 Dec;7(12):1336-42. doi: 10.4161/hv.7.12.18333. Epub 2011 Dec 1.

*   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 26, 2007)
540
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and female older adults greater than or equal to 50 years of age

Exclusion Criteria:

  • Any adult with a history of previous hepatitis B infection
  • A history of vaccination with any hepatitis B vaccine
  • Recent (<72 hours) history of febrile illness (oral temperature =37.8ºC/=100.0ºF)
  • Known or suspected hypersensitivity to any component of RECOMBIVAX HB™ or ENGERIX-B™ (e.g., aluminum, yeast)
  • Recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product
  • Receipt of licensed inactivated vaccines within 14 days prior to first injection with the study vaccine
  • Receipt of licensed live virus vaccines within the 30 days prior to injection with the study vaccine
  • Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine
  • Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids
  • Pregnant women, nursing mothers, and women planning to become pregnant within the study period
  • Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
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 Canada,   Denmark,   Sweden,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00440531
Other Study ID Numbers  ICMJE V232-059
2007_516
Has Data Monitoring Committee Not Provided
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 Monitor Merck Sharp & Dohme LLC
PRS Account Merck Sharp & Dohme LLC
Verification Date March 2017

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