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 Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 596
- Locations
- 10
- Primary Endpoint
- Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 41 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value
Time Frame: At Month 7
Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration ≥ 15mIU/mL; seropositivity for anti-HBs antibodies was defined as anti-HBs antibody concentration ≥ 3.3 mIU/mL.
Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen
Time Frame: At Month 7
A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL.
Antibody Concentrations for Anti-hepatitis A Virus (Anti-HAV) and Anti-hepatitis B Surface (Anti-HBs) Antigens
Time Frame: At Month 7 after Twinrix vaccination
Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively.
Secondary Outcomes
- Anti-HAV and Anti-HBs Antibody Concentrations(At Month 12 (M12), Month 24 (M24) and Month 36 (M36))
- Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender(At Month 7)
- Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age(At Month 7)
- Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI)(At Month 7)
- Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status(At Month 7)
- Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption(At Month 7)
- Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication(At Month 7)
- Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition(At Month 7)
- Number of Seroprotected Subjects Against HBs Antigen, by Gender(At Month 7)
- Number of Seroprotected Subjects Against HBs Antigen, by Age(At Month 7)
- Number of Seroprotected Subjects Against HBs Antigen, by BMI(At Month 7)
- Number of Seroprotected Subjects Against HBs Antigen, by Smoking Status(At Month 7)
- Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication(At Month 7)
- Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition(At Month 7)
- Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value(At Month 12 (M12), Month 24 (M24) and Month 36 (M36))
- Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen(At Month 12 (M12), Month 24 (M24) and Month 36 (M36))
- Number of Subjects With Serious Adverse Events (SAEs)(From Day 0 up to Month 7)
- Number of Seroprotected Subjects Against HBs Antigen, by Alcohol Consumption(At Month 7)
- Number of Seroprotected Subjects Against HBs Antigen, by Concomitant Medication(At Month 7)
- Number of Seroprotected Subjects Against HBs Antigen, by Medical Condition(At Month 7)
- Anti-HAV and Anti-HBs Antibody Concentrations, by Gender(At Month 7)
- Anti-HAV and Anti-HBs Antibody Concentrations, by Age(At Month 7)
- Anti-HAV and Anti-HBs Antibody Concentrations, by BMI(At Month 7)
- Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status(At Month 7)
- Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption(At Month 7)
- Number of Subjects With SAEs(At Month 12 (M12), Month 24 (M24) and Month 36 (M36))