Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc

Phase 4

Completed

• Conditions: Hepatitis A; Hepatitis B
• Interventions: Biological: TWINRIX™; Biological: HB VAX PRO™; Biological: Engerix™-B; Biological: HAVRIX™; Biological: Vaqta™

• Registration Number: NCT00289731
• Lead Sponsor: GlaxoSmithKline

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-11-24
• Primary Completion: 2004-12-21
• Study Completion: 2004-12-21
• Study First Submitted: 2006-02-09
• Study First Submitted QC: 2006-02-09
• Study First Posted: 2006-02-10
• Results First Submitted: 2017-01-30
• Results First Submitted QC: 2018-03-22
• Results First Posted: 2018-10-03
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-29
• Last Update Posted: 2019-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 596

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Twinrix Group	TWINRIX™	Healthy and non-healthy male or female subjects, aged 41 years or older, who received combined Twinrix™ (720/20) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule.
HB VAX PRO+Vaqta Group	HB VAX PRO™	Healthy and non-healthy male or female subjects, aged 41 years or older, who received separate administrations of HB VAX PRO™ (10 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule and Vaqta™ (50 IU) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.
Engerix-B+Havrix Group	Engerix™-B	Healthy and non-healthy male or female subjects, aged 41 years or older, who received separate administrations of Engerix™-B (20 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule and Havrix™ (1440 EL.U) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.
Engerix-B+Havrix Group	HAVRIX™	Healthy and non-healthy male or female subjects, aged 41 years or older, who received separate administrations of Engerix™-B (20 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule and Havrix™ (1440 EL.U) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.
HB VAX PRO+Vaqta Group	Vaqta™	Healthy and non-healthy male or female subjects, aged 41 years or older, who received separate administrations of HB VAX PRO™ (10 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule and Vaqta™ (50 IU) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value	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	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	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 Outcome Measures

Name	Time	Method
Anti-HAV and Anti-HBs Antibody Concentrations	At Month 12 (M12), Month 24 (M24) and Month 36 (M36)	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).
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender	At Month 7	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).
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age	At Month 7	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.
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI)	At Month 7	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.
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status	At Month 7	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).
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption	At Month 7	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.
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication	At Month 7	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).
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition	At Month 7	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.
Number of Seroprotected Subjects Against HBs Antigen, by Gender	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. The seroprotection rates were stratified by gender (females and males).
Number of Seroprotected Subjects Against HBs Antigen, by Age	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. The seroprotection rates were stratified by age as follows: ≤ 50 years of age (YOA), 51-60 YOA and ≥ 61 YOA.
Number of Seroprotected Subjects Against HBs Antigen, by BMI	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. The seroprotection rates were stratified by BMI as follows: healthy, overweight and obese.
Number of Seroprotected Subjects Against HBs Antigen, by Smoking Status	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. The seroprotection rates were stratified by smoking status (smokers and non-smokers).
Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication	At Month 7	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).
Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition	At Month 7	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.
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)	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).
Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen	At Month 12 (M12), Month 24 (M24) and Month 36 (M36)	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).
Number of Subjects With Serious Adverse Events (SAEs)	From Day 0 up to Month 7	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.
Number of Seroprotected Subjects Against HBs Antigen, by Alcohol Consumption	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. The seroprotection rates were stratified by alcohol consumption as follows: none or mild, moderate and heavy.
Number of Seroprotected Subjects Against HBs Antigen, by Concomitant Medication	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. The seroprotection rates were stratified by concomitant medication (concomitant medication and no concomitant medication).
Number of Seroprotected Subjects Against HBs Antigen, by Medical Condition	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. The seroprotection rates were stratified by medical condition as follows: no medical condition, past medical condition and current medical condition.
Anti-HAV and Anti-HBs Antibody Concentrations, by Gender	At Month 7	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).
Anti-HAV and Anti-HBs Antibody Concentrations, by Age	At Month 7	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.
Anti-HAV and Anti-HBs Antibody Concentrations, by BMI	At Month 7	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.
Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status	At Month 7	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).
Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption	At Month 7	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.
Number of Subjects With SAEs	At Month 12 (M12), Month 24 (M24) and Month 36 (M36)	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Elmshorn, Schleswig-Holstein, Germany