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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.
First Received: February 9, 2006   Last Updated: October 27, 2008   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00289731
  Purpose

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 A
Hepatitis B
Biological: Vaqta™
Biological: TWINRIX™
Biological: Engerix™-B
Biological: HAVRIX™
Biological: HB VAX PRO™
Phase IV

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B
Drug Information available for: Twinrix Hepatitis B Vaccines Hepatitis A Vaccines
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

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: Yes ]
  • 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: Yes ]

Enrollment: 596
Study Start Date: November 2003
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A: Experimental
GSK Biologicals' combined Hepatitis A and B vaccine was administered.
Biological: TWINRIX™
Intramuscular injection, 3 doses
Group C: Active Comparator
Aventis Pasteur's monovalent hepatitis A and hepatitis B vaccines were administered separately.
Biological: Vaqta™
Intramuscular injection, 2 doses
Biological: HB VAX PRO™
Intramuscular injection, 3 doses
Group B: Active Comparator
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

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.

  Eligibility

Ages Eligible for Study:   41 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

Locations
Belgium
GSK Investigational Site
Wilrijk, Belgium, 2610
Czech Republic
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 01
Germany, Brandenburg
GSK Investigational Site
Finsterwalde, Brandenburg, Germany, 03238
Germany, Sachsen
GSK Investigational Site
Geringswalde, Sachsen, Germany, 09326
GSK Investigational Site
Dresden, Sachsen, Germany, 01129
GSK Investigational Site
Pirna, Sachsen, Germany, 01796
Germany, Schleswig-Holstein
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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 100382, 100383 (Y1), 100384 (Y2), 100385 (Y3)
Study First Received: February 9, 2006
Last Updated: October 27, 2008
ClinicalTrials.gov Identifier: NCT00289731     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis B
Picornaviridae Infections
Hepatitis, Viral, Human
Hepatitis A
DNA Virus Infections
Enterovirus Infections

Additional relevant MeSH terms:
Virus Diseases
Hepatitis
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Hepatitis B
Picornaviridae Infections
Hepatitis, Viral, Human
Hepatitis A
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009