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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
596
Intramuscular injection, 3 doses
Intramuscular injection, 3 doses
Intramuscular injection, 2 doses
GSK Investigational Site
Wilrijk, Belgium
GSK Investigational Site
Hradec Králové, Czechia
GSK Investigational Site
Finsterwalde, Brandenburg, Germany
GSK Investigational Site
Dresden, Saxony, Germany
Antibody Concentrations for Anti-hepatitis A Virus (Anti-HAV) and Anti-hepatitis B Surface (Anti-HBs) Antigens
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.
Time frame: At Month 7 after Twinrix vaccination
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value
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.
Time frame: At Month 7
Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen
A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL.
Time frame: At Month 7
Anti-HAV and Anti-HBs Antibody Concentrations
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.
Time frame: At Month 7
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender
Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. The seropositivity rates were stratified by gender (females and males).
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Intramuscular injection, 3 doses
Intramuscular injection, 2 doses
GSK Investigational Site
Geringswalde, Saxony, Germany
GSK Investigational Site
Pirna, Saxony, Germany
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, Germany
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany
GSK Investigational Site
Elmshorn, Schleswig-Holstein, Germany
Time frame: At Month 7
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age
Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. The seropositivity rates were stratified by age as follows: ≤ 50 years of age (YOA), 51-60 YOA and ≥ 61 YOA.
Time frame: At Month 7
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI)
Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. The seropositivity rates were stratified by BMI as follows: healthy, overweight and obese.
Time frame: At Month 7
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status
Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. The seropositivity rates were stratified by smoking status (smokers and non-smokers).
Time frame: At Month 7
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption
Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. The seropositivity rates were stratified by alcohol consumption as follows: None or Mild, Moderate and Heavy.
Time frame: At Month 7
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication
Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. The seropositivity rates were stratified by concomitant medication (concomitant medication and no concomitant medication).
Time frame: At Month 7
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition
Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. The seropositivity rates were stratified by medical condition as follows: no medical condition, past medical condition and current medical condition.
Time frame: At Month 7
Number of Seroprotected Subjects Against HBs Antigen, by Gender
A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. The seroprotection rates were stratified by gender (females and males).
Time frame: At Month 7
Number of Seroprotected Subjects Against HBs Antigen, by Age
A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. The seroprotection rates were stratified by age as follows: ≤ 50 years of age (YOA), 51-60 YOA and ≥ 61 YOA.
Time frame: At Month 7
Number of Seroprotected Subjects Against HBs Antigen, by BMI
A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. The seroprotection rates were stratified by BMI as follows: healthy, overweight and obese.
Time frame: At Month 7
Number of Seroprotected Subjects Against HBs Antigen, by Smoking Status
A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. The seroprotection rates were stratified by smoking status (smokers and non-smokers).
Time frame: At Month 7
Number of Seroprotected Subjects Against HBs Antigen, by Alcohol Consumption
A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. The seroprotection rates were stratified by alcohol consumption as follows: none or mild, moderate and heavy.
Time frame: At Month 7
Number of Seroprotected Subjects Against HBs Antigen, by Concomitant Medication
A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. The seroprotection rates were stratified by concomitant medication (concomitant medication and no concomitant medication).
Time frame: At Month 7
Number of Seroprotected Subjects Against HBs Antigen, by Medical Condition
A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. The seroprotection rates were stratified by medical condition as follows: no medical condition, past medical condition and current medical condition.
Time frame: At Month 7
Anti-HAV and Anti-HBs Antibody Concentrations, by Gender
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. The antibody concentrations were stratified by gender (females and males).
Time frame: At Month 7
Anti-HAV and Anti-HBs Antibody Concentrations, by Age
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. The antibody concentrations were stratified by age as follows: ≤ 50 years of age (YOA), 51-60 YOA and ≥ 61 YOA.
Time frame: At Month 7
Anti-HAV and Anti-HBs Antibody Concentrations, by BMI
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. The antibody concentrations were stratified by BMI as follows: healthy, overweight and obese.
Time frame: At Month 7
Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status
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. The antibody concentrations were stratified by smoking status (smokers and non-smokers).
Time frame: At Month 7
Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption
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. The antibody concentrations were stratified by alcohol consumption as follows: none or mild, moderate and heavy.
Time frame: At Month 7
Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication
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. The antibody concentrations were stratified by concomitant medication (concomitant medication and no concomitant medication).
Time frame: At Month 7
Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition
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. The antibody concentrations were stratified by medical condition as follows: no medical condition, past medical condition and current medical condition.
Time frame: At Month 7
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value
Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. Anti-HBs AUSAB = anti-HBs antibody concentrations were tested with AUSAB EIA /Abbott assay; Anti-HBs in-house = anti-HBs antibody concentrations were tested with in-house assay (bridging).
Time frame: At Month 12 (M12), Month 24 (M24) and Month 36 (M36)
Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen
A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. Anti-HBs AUSAB = anti-HBs antibody concentrations were tested with AUSAB EIA /Abbott assay; Anti-HBs in-house = anti-HBs antibody concentrations were tested with in-house assay (bridging).
Time frame: At Month 12 (M12), Month 24 (M24) and Month 36 (M36)
Anti-HAV and Anti-HBs Antibody Concentrations
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. Anti-HBs AUSAB = anti-HBs antibody concentrations were tested with AUSAB EIA /Abbott assay; Anti-HBs in-house = anti-HBs antibody concentrations were tested with in-house assay (bridging).
Time frame: At Month 12 (M12), Month 24 (M24) and Month 36 (M36)
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: 3 subjects reported SAEs prior to administration of the first dose of vaccination.
Time frame: From Day 0 up to Month 7
Number of Subjects With SAEs
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: 3 subjects reported SAEs prior to administration of the first dose of vaccination.
Time frame: At Month 12 (M12), Month 24 (M24) and Month 36 (M36)