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.
Information provided by:
ClinicalTrials.gov Identifier:
First received: February 9, 2006
Last updated: October 27, 2011
Last verified: October 2011
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.

Condition Intervention Phase
Hepatitis B
Hepatitis A
Biological: TWINRIX™
Biological: Engerix™-B
Biological: HAVRIX™
Biological: HB VAX PRO™
Biological: Vaqta™
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti- HAV and anti-HBs- concentrations [ Time Frame: 1 month after the last vaccine dose (at Month 7) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 577
Study Start Date: November 2003
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
GSK Biologicals' combined Hepatitis A and B vaccine was administered.
Biological: TWINRIX™
Intramuscular injection, 3 doses
Active Comparator: Group B
GSK Biologicals' monovalent hepatitis A and hepatitis B vaccines were administered separately.
Biological: Engerix™-B
Intramuscular injection, 3 doses
Biological: HAVRIX™
Intramuscular injection, 2 doses
Active Comparator: Group C
Aventis Pasteur's monovalent hepatitis A and hepatitis B vaccines were administered separately.
Biological: HB VAX PRO™
Intramuscular injection, 3 doses
Biological: Vaqta™
Intramuscular injection, 2 doses

Detailed Description:
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.

Ages Eligible for Study:   41 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289731

GSK Investigational Site
Wilrijk, Belgium, 2610
Czech Republic
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 01
GSK Investigational Site
Finsterwalde, Brandenburg, Germany, 03238
GSK Investigational Site
Dresden, Sachsen, Germany, 01129
GSK Investigational Site
Geringswalde, Sachsen, Germany, 09326
GSK Investigational Site
Pirna, Sachsen, Germany, 01796
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, Germany, 24576
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany, 23795
GSK Investigational Site
Elmshorn, Schleswig-Holstein, Germany, 25335
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00289731     History of Changes
Other Study ID Numbers: 100382  100383  100384  100385 
Study First Received: February 9, 2006
Last Updated: October 27, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
Combined hepatitis A and hepatitis B vaccine
Hepatitis B
Hepatitis A
Monovalent hepatitis A and hepatitis B vaccines

Additional relevant MeSH terms:
Hepatitis B
Hepatitis A
Hepatitis, Viral, Human
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Liver Diseases
Digestive System Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2016