Last updated: 10/30/2019 12:10:22
Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Antibody concentrations for anti-hepatitis A virus (anti-HAV) and anti-hepatitis B surface (anti-HBs) antigens
Timeframe: At Month 7 after Twinrix vaccination
Number of subjects with anti-HAV and anti-HBs antibody concentrations above the cut-off value
Timeframe: At Month 7
Number of seroprotected subjects against hepatitis B surface (HBs) antigen
Timeframe: At Month 7
Secondary outcomes:
Anti-HAV and anti-HBs antibody concentrations
Timeframe: At Month 7
Number of subjects with anti-HAV and anti-HBs antibody concentrations above the cut-off value, by gender
Timeframe: At Month 7
Number of subjects with anti-HAV and anti-HBs antibody concentrations above the cut-off value, by age
Timeframe: At Month 7
Number of subjects with anti-HAV and anti-HBs antibody concentrations above the cut-off value, by Body Mass Index (BMI)
Timeframe: At Month 7
Number of subjects with anti-HAV and anti-HBs antibody concentrations above the cut-off value, by smoking status
Timeframe: At Month 7
Number of subjects with anti-HAV and anti-HBs antibody concentrations above the cut-off value, by alcohol consumption
Timeframe: At Month 7
Number of subjects with anti-HAV and anti-HBs antibody concentrations above the cut-off value, by concomitant medication
Timeframe: At Month 7
Number of subjects with anti-HAV and anti-HBs antibody concentrations above the cut-off value, by medical condition
Timeframe: At Month 7
Number of seroprotected subjects against HBs antigen, by gender
Timeframe: At Month 7
Number of seroprotected subjects against HBs antigen, by age
Timeframe: At Month 7
Number of seroprotected subjects against HBs antigen, by BMI
Timeframe: At Month 7
Number of seroprotected subjects against HBs antigen, by smoking status
Timeframe: At Month 7
Number of seroprotected subjects against HBs antigen, by alcohol consumption
Timeframe: At Month 7
Number of seroprotected subjects against HBs antigen, by concomitant medication
Timeframe: At Month 7
Number of seroprotected subjects against HBs antigen, by medical condition
Timeframe: At Month 7
Anti-HAV and anti-HBs antibody concentrations, by gender
Timeframe: At Month 7
Anti-HAV and anti-HBs antibody concentrations, by age
Timeframe: At Month 7
Anti-HAV and anti-HBs antibody concentrations, by BMI
Timeframe: At Month 7
Anti-HAV and anti-HBs antibody concentrations, by smoking status
Timeframe: At Month 7
Anti-HAV and anti-HBs antibody concentrations, by alcohol consumption
Timeframe: At Month 7
Anti-HAV and anti-HBs antibody concentrations, by concomitant medication
Timeframe: At Month 7
Anti-HAV and anti-HBs antibody concentrations, by medical condition
Timeframe: At Month 7
Number of subjects with anti-HAV and anti-HBs antibody concentrations above the cut-off value
Timeframe: At Month 12 (M12), Month 24 (M24) and Month 36 (M36)
Number of seroprotected subjects against hepatitis B surface (HBs) antigen
Timeframe: At Month 12 (M12), Month 24 (M24) and Month 36 (M36)
Anti-HAV and anti-HBs antibody concentrations
Timeframe: At Month 12 (M12), Month 24 (M24) and Month 36 (M36)
Number of subjects with serious adverse events (SAEs)
Timeframe: From Day 0 up to Month 7
Number of subjects with SAEs
Timeframe: At Month 12 (M12), Month 24 (M24) and Month 36 (M36)
Interventions:
Enrollment:
596
Primary completion date:
2004-21-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Van der Wielen M et al. (2006) Hepatitis A/B vaccination of adults over 40 years old: Comparison of three vaccine regimens and effect of influencing factors. Vaccine. 24 (26): 5509-5515.
Medical condition
Hepatitis B
Product
SB208127
Collaborators
Not applicable
Study date(s)
November 2003 to December 2004
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
41+ years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
Exclusion criteria:
- 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.
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.
Trial location(s)
Location
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, Germany, 24576
Status
Study Complete
Location
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany, 23795
Status
Study Complete
Location
GSK Investigational Site
Elmshorn, Schleswig-Holstein, Germany, 25335
Status
Study Complete
Location
GSK Investigational Site
Finsterwalde, Brandenburg, Germany, 03238
Status
Study Complete
Showing 1 - 6 of 9 Results
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2004-21-12
Actual study completion date
2004-21-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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