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Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00289731
First received: February 9, 2006
Last updated: October 27, 2011
Last verified: October 2011
History of Changes

February 9, 2006
October 27, 2011
November 2003
May 2007   (final data collection date for primary outcome measure)
Anti- HAV and anti-HBs- concentrations [ Time Frame: 1 month after the last vaccine dose (at Month 7) ] [ Designated as safety issue: No ]
To assess anti-HAV & anti-HBs antibody concentrations 1 month after primary vaccination course in subjects who were vaccinated with combined hepA & hepB vaccine; and also to evaluate the long-term persistence of anti-HAV and anti-HBs antibodies at Months
Complete list of historical versions of study NCT00289731 on ClinicalTrials.gov Archive Site
  • Anti-HAV, and anti-HBs antibody concentrations. [ Time Frame: At Months 12, 24, 36 and 48 ] [ Designated as safety issue: No ]
  • Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs). [ Time Frame: Up to Month 7 ] [ Designated as safety issue: No ]
  • Occurrence, intensity and relationship to vaccination of SAEs with causal relationship to vaccination or referring to hepatitis A or B infection. [ Time Frame: After Month 7 and up to the study end. ] [ Designated as safety issue: No ]
To assess anti-HAV and anti-HBs antibody concentrations 1 month after primary vaccination course in subjects who were vaccinated with monovalent hepA & B vaccine (from GSK Biologicals' or different manufacturer) and to record SAEs reported throughout the
Not Provided
Not Provided
 
Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc
Evaluate the Effect of Several Risk Factors That Are Likely to Influence the Immunogenicity of GSK Biologicals' Combined Hepatitis A & B Vaccine, vs Separately Administered Monovalent Hepatitis A and Hepatitis B Vaccines

The focus of this study is to evaluate how risk factors like age, gender, body mass index, smoking, alcohol consumption, etc. can influence immune response when subjects are vaccinated with GSK Biologicals' combined hepatitis A/hepatitis B vaccine or monovalent hepatitis A and B vaccines (from GSK Biologicals' or different manufacturers). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

The study will also evaluate the persistence of hepatitis A and hepatitis B antibodies at months 12, 24 and 36 after the first dose of primary vaccination course.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Hepatitis B
  • Hepatitis A
  • Biological: TWINRIX™
    Intramuscular injection, 3 doses
  • Biological: Engerix™-B
    Intramuscular injection, 3 doses
  • Biological: HAVRIX™
    Intramuscular injection, 2 doses
  • Biological: HB VAX PRO™
    Intramuscular injection, 3 doses
  • Biological: Vaqta™
    Intramuscular injection, 2 doses
  • Experimental: Group A
    GSK Biologicals' combined Hepatitis A and B vaccine was administered.
    Intervention: Biological: TWINRIX™
  • Active Comparator: Group B
    GSK Biologicals' monovalent hepatitis A and hepatitis B vaccines were administered separately.
    Interventions:
    • Biological: Engerix™-B
    • Biological: HAVRIX™
  • Active Comparator: Group C
    Aventis Pasteur's monovalent hepatitis A and hepatitis B vaccines were administered separately.
    Interventions:
    • Biological: HB VAX PRO™
    • Biological: Vaqta™
Van der Wielen M, Van Damme P, Chlibek R, Smetana J, von Sonnenburg F. Hepatitis A/B vaccination of adults over 40 years old: comparison of three vaccine regimens and effect of influencing factors. Vaccine. 2006 Jun 29;24(26):5509-15. Epub 2006 May 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
577
May 2007
May 2007   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • Healthy and non-healthy male or female aged 41 years or older at the time of the first vaccination.
  • Written informed consent obtained from the subject.
  • No serological signs of hepatitis A or B infection at screening.
  • If the subject is female, she must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • History of any hepatitis A or hepatitis B vaccination or infection, since the primary vaccination study 100382.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute disease at the time of enrolment. .
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions during the primary vaccination period.
Both
41 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Germany
 
NCT00289731
100382, 100383, 100384, 100385
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2011

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