Hepatitis B, Hepatitis A
Conditions
Keywords
Combined hepatitis A and hepatitis B vaccine, Hepatitis B, Hepatitis A, Monovalent hepatitis A and hepatitis B vaccines
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.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
41 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| Anti-HAV and Anti-HBs Antibody Concentrations | 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. |
| 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. |
| 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 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. |
| 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. |
| 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. |
Countries
Belgium, Czechia, Germany
Participant flow
Pre-assignment details
A total of 596 subjects (199 in Twinrix Group, 200 in Engerix-B+Havrix Group and 197 in HB VAX PRO+Vaqta Group) were enrolled and vaccinated in the study.
Participants by arm
| Arm | Count |
|---|---|
| Twinrix Group 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. | 199 |
| Engerix-B+Havrix Group 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. | 200 |
| HB VAX PRO+Vaqta Group 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. | 197 |
| Total | 596 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 | 2 |
| Overall Study | Other | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
|---|---|---|---|---|
| Age, Continuous | 55.17 Years STANDARD_DEVIATION 9.59 | 55.2 Years STANDARD_DEVIATION 9.24 | 55.3 Years STANDARD_DEVIATION 9.91 | 55.0 Years STANDARD_DEVIATION 9.64 |
| Race/Ethnicity, Customized Black | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 595 Participants | 199 Participants | 200 Participants | 196 Participants |
| Sex: Female, Male Female | 298 Participants | 97 Participants | 100 Participants | 101 Participants |
| Sex: Female, Male Male | 298 Participants | 102 Participants | 100 Participants | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 199 | 2 / 200 | 2 / 197 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 11 / 199 | 14 / 200 | 16 / 197 |
Outcome results
Primary
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
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Twinrix Group | Antibody Concentrations for Anti-hepatitis A Virus (Anti-HAV) and Anti-hepatitis B Surface (Anti-HBs) Antigens | Anti-HAV | 2746.5 mIU/mL |
| Twinrix Group | Antibody Concentrations for Anti-hepatitis A Virus (Anti-HAV) and Anti-hepatitis B Surface (Anti-HBs) Antigens | Anti-HBs | 1153.9 mIU/mL |
Primary
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
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Twinrix Group | Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen | 166 Participants |
| Engerix-B+Havrix Group | Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen | 145 Participants |
| HB VAX PRO+Vaqta Group | Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen | 125 Participants |
Comparison: Difference in seroprotection rates against hepatitis B surface (HBs) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines Engerix-B at Months 0, 1 and 6 and Havrix at Months 0 and 6 (Engerix-B+Havrix Group), in terms of anti-HBs seroprotection rates, at Month 7.95% CI: [4.97, 19.35]
Comparison: Difference in seropositivity rates against hepatitis B surface (HBs) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines HB VAX PRO at Months 0, 1 and 6 and Vaqta at Months 0 and 6 (HB VAX PRO+Vaqta Group), in terms of anti-HBs seroprotection rates, at Month 7.95% CI: [12.92, 28.62]
Primary
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
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HAV | 176 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HBs | 168 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HAV | 180 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HBs | 152 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HAV | 174 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HBs | 137 Participants |
Comparison: Difference in seropositivity rates against hepatitis A virus (HAV) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines Engerix-B at Months 0, 1 and 6 and Havrix at Months 0 and 6 (Engerix-B+Havrix Group), in terms of anti-HAV seropositivity rates, at Month 7.95% CI: [-5.34, 1.48]
Comparison: Difference in seropositivity rates against hepatitis A virus (HAV) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines HB VAX PRO at Months 0, 1 and 6 and Vaqta at Months 0 and 6 (HB VAX PRO+Vaqta Group), in terms of anti-HAV seropositivity rates, at Month 7.95% CI: [-5.31, 1.6]
Secondary
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
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HAV | 1394.3 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HBs | 491.2 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HAV | 3707.2 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HBs | 179.1 mIU/mL |
Secondary
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)
Population: The analysis was performed on the LT ATP cohort for immunogenicity, which included all subjects who were included in the ATP cohort for immunogenicity in the primary study and who came within the blood sampling time interval at Months 12, 24 and 36.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HAV, M12 | 891.0 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HBs, M24 AUSAB | 113.2 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HAV, M36 | 216.9 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HBs, M12 AUSAB | 339.2 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HBs, M36 in-house | 72.1 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HBs, M24 in-house | 99.3 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HAV, M24 | 271.6 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HAV, M36 | 185.4 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HBs, M24 AUSAB | 46.5 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HAV, M12 | 530.6 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HAV, M24 | 209.9 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HBs, M12 AUSAB | 149.4 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HBs, M24 in-house | 40.8 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HBs, M36 in-house | 34.1 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HBs, M24 AUSAB | 21.3 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HAV, M12 | 1200.5 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HBs, M36 in-house | 18.9 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HBs, M24 in-house | 22.3 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HAV, M36 | 278.5 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HBs, M12 AUSAB | 53.1 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HAV, M24 | 362.0 mIU/mL |
Secondary
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
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Age | Anti-HBs, 51-60 YOA | 986.4 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Age | Anti-HBs, ≥ 61 YOA | 814.6 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Age | Anti-HAV, ≥ 61 YOA | 2019.4 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Age | Anti-HAV, ≤ 50 YOA | 4034.0 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Age | Anti-HBs, ≤ 50 YOA | 1839.9 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Age | Anti-HAV, 51-60 YOA | 2521.6 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Age | Anti-HAV, ≤ 50 YOA | 1769.8 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Age | Anti-HBs, 51-60 YOA | 324.1 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Age | Anti-HAV, 51-60 YOA | 1714.8 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Age | Anti-HAV, ≥ 61 YOA | 873.8 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Age | Anti-HBs, ≥ 61 YOA | 522.6 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Age | Anti-HBs, ≤ 50 YOA | 753.7 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Age | Anti-HBs, ≥ 61 YOA | 75.3 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Age | Anti-HAV, ≤ 50 YOA | 5166.9 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Age | Anti-HAV, 51-60 YOA | 3822.8 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Age | Anti-HAV, ≥ 61 YOA | 2566.2 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Age | Anti-HBs, ≤ 50 YOA | 217.2 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Age | Anti-HBs, 51-60 YOA | 286.6 mIU/mL |
Secondary
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
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption | Anti-HAV, Moderate | 3174.6 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption | Anti-HAV, None or Mild | 2505.1 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption | Anti-HBs, Moderate | 1136.7 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption | Anti-HAV, Heavy | 3195.3 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption | Anti-HBs, None or Mild | 1043.1 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption | Anti-HBs, Heavy | 3246.9 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption | Anti-HBs, None or Mild | 534.9 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption | Anti-HBs, Moderate | 467.3 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption | Anti-HBs, Heavy | 223.4 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption | Anti-HAV, Moderate | 1453.8 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption | Anti-HAV, Heavy | 899.8 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption | Anti-HAV, None or Mild | 1403.6 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption | Anti-HBs, Heavy | 96.6 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption | Anti-HAV, None or Mild | 3731.1 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption | Anti-HAV, Moderate | 3754.3 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption | Anti-HAV, Heavy | 3292.6 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption | Anti-HBs, None or Mild | 230.7 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption | Anti-HBs, Moderate | 132.7 mIU/mL |
Secondary
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
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by BMI | Anti-HBs, Overweight | 1540.8 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by BMI | Anti-HAV, Obese | 1984.0 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by BMI | Anti-HAV, Overweight | 2846.6 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by BMI | Anti-HBs, Obese | 443.5 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by BMI | Anti-HBs, Healthy | 2140.5 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by BMI | Anti-HAV, Healthy | 3565.4 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by BMI | Anti-HBs, Healthy | 505.4 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by BMI | Anti-HBs, Overweight | 609.4 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by BMI | Anti-HAV, Healthy | 1569.2 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by BMI | Anti-HAV, Overweight | 1663.9 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by BMI | Anti-HAV, Obese | 1004.8 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by BMI | Anti-HBs, Obese | 368.3 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by BMI | Anti-HBs, Obese | 68.1 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by BMI | Anti-HAV, Obese | 2716.2 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by BMI | Anti-HBs, Overweight | 165.9 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by BMI | Anti-HBs, Healthy | 475.2 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by BMI | Anti-HAV, Overweight | 3943.9 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by BMI | Anti-HAV, Healthy | 4756.2 mIU/mL |
Secondary
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
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication | Anti-HAV, concomitant medication | 2680.3 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication | Anti-HAV, no concomitant medication | 3505.5 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication | Anti-HBs, concomitant medication | 1138.0 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication | Anti-HBs, no concomitant medication | 1329.9 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication | Anti-HBs, no concomitant medication | 170.8 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication | Anti-HAV, concomitant medication | 1398.4 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication | Anti-HBs, concomitant medication | 533.4 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication | Anti-HAV, no concomitant medication | 1343.0 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication | Anti-HBs, no concomitant medication | 255.8 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication | Anti-HAV, no concomitant medication | 3225.1 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication | Anti-HBs, concomitant medication | 174.1 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication | Anti-HAV, concomitant medication | 3752.7 mIU/mL |
Secondary
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
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Gender | Anti-HAV, Females | 2968.1 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Gender | Anti-HBs, Males | 697.1 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Gender | Anti-HAV, Males | 2550.3 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Gender | Anti-HBs, Females | 1957.5 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Gender | Anti-HAV, Females | 2089.2 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Gender | Anti-HBs, Females | 474.2 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Gender | Anti-HBs, Males | 509.4 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Gender | Anti-HAV, Males | 947.0 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Gender | Anti-HBs, Males | 102.2 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Gender | Anti-HAV, Males | 2546.4 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Gender | Anti-HBs, Females | 273.8 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Gender | Anti-HAV, Females | 5307.0 mIU/mL |
Secondary
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
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition | Anti-HAV,current medical condition | 2445.3 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition | Anti-HAV,no medical condition | 4765.5 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition | Anti-HAV,past medical condition | 3438.3 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition | Anti-HBs,no medical condition | 2743.4 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition | Anti-HBs,past medical condition | 1537.3 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition | Anti-HBs,current medical condition | 964.6 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition | Anti-HAV,past medical condition | 1882.2 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition | Anti-HBs,no medical condition | 435.2 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition | Anti-HBs,current medical condition | 464.4 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition | Anti-HAV,current medical condition | 1245.2 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition | Anti-HBs,past medical condition | 799.5 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition | Anti-HAV,no medical condition | 2187.5 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition | Anti-HAV,no medical condition | 5531.9 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition | Anti-HAV,past medical condition | 4073.9 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition | Anti-HAV,current medical condition | 3464.3 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition | Anti-HBs,current medical condition | 152.2 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition | Anti-HBs,past medical condition | 349.4 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition | Anti-HBs,no medical condition | 345.1 mIU/mL |
Secondary
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
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status | Anti-HAV, Smokers | 1844.6 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status | Anti-HAV, Non-Smokers | 3216.5 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status | Anti-HBs, Smokers | 654.4 mIU/mL |
| Twinrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status | Anti-HBs, Non-smokers | 1438.3 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status | Anti-HBs, Non-smokers | 525.5 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status | Anti-HAV, Smokers | 1433.2 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status | Anti-HBs, Smokers | 416.4 mIU/mL |
| Engerix-B+Havrix Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status | Anti-HAV, Non-Smokers | 1379.2 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status | Anti-HBs, Non-smokers | 198.3 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status | Anti-HAV, Non-Smokers | 3766.3 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status | Anti-HBs, Smokers | 108.1 mIU/mL |
| HB VAX PRO+Vaqta Group | Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status | Anti-HAV, Smokers | 3456.0 mIU/mL |
Secondary
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
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Twinrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Age | 51-60 YOA | 63 Participants |
| Twinrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Age | ≤ 50 YOA | 57 Participants |
| Twinrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Age | ≥ 61 YOA | 46 Participants |
| Engerix-B+Havrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Age | 51-60 YOA | 55 Participants |
| Engerix-B+Havrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Age | ≤ 50 YOA | 48 Participants |
| Engerix-B+Havrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Age | ≥ 61 YOA | 42 Participants |
| HB VAX PRO+Vaqta Group | Number of Seroprotected Subjects Against HBs Antigen, by Age | ≤ 50 YOA | 52 Participants |
| HB VAX PRO+Vaqta Group | Number of Seroprotected Subjects Against HBs Antigen, by Age | ≥ 61 YOA | 30 Participants |
| HB VAX PRO+Vaqta Group | Number of Seroprotected Subjects Against HBs Antigen, by Age | 51-60 YOA | 43 Participants |
Secondary
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
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Twinrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Alcohol Consumption | None or Mild | 105 Participants |
| Twinrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Alcohol Consumption | Moderate | 50 Participants |
| Twinrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Alcohol Consumption | Heavy | 11 Participants |
| Engerix-B+Havrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Alcohol Consumption | None or Mild | 87 Participants |
| Engerix-B+Havrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Alcohol Consumption | Moderate | 52 Participants |
| Engerix-B+Havrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Alcohol Consumption | Heavy | 6 Participants |
| HB VAX PRO+Vaqta Group | Number of Seroprotected Subjects Against HBs Antigen, by Alcohol Consumption | None or Mild | 76 Participants |
| HB VAX PRO+Vaqta Group | Number of Seroprotected Subjects Against HBs Antigen, by Alcohol Consumption | Moderate | 41 Participants |
| HB VAX PRO+Vaqta Group | Number of Seroprotected Subjects Against HBs Antigen, by Alcohol Consumption | Heavy | 8 Participants |
Secondary
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
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Twinrix Group | Number of Seroprotected Subjects Against HBs Antigen, by BMI | Healthy | 52 Participants |
| Twinrix Group | Number of Seroprotected Subjects Against HBs Antigen, by BMI | Obese | 52 Participants |
| Twinrix Group | Number of Seroprotected Subjects Against HBs Antigen, by BMI | Overweight | 62 Participants |
| Engerix-B+Havrix Group | Number of Seroprotected Subjects Against HBs Antigen, by BMI | Healthy | 51 Participants |
| Engerix-B+Havrix Group | Number of Seroprotected Subjects Against HBs Antigen, by BMI | Obese | 43 Participants |
| Engerix-B+Havrix Group | Number of Seroprotected Subjects Against HBs Antigen, by BMI | Overweight | 51 Participants |
| HB VAX PRO+Vaqta Group | Number of Seroprotected Subjects Against HBs Antigen, by BMI | Obese | 39 Participants |
| HB VAX PRO+Vaqta Group | Number of Seroprotected Subjects Against HBs Antigen, by BMI | Overweight | 40 Participants |
| HB VAX PRO+Vaqta Group | Number of Seroprotected Subjects Against HBs Antigen, by BMI | Healthy | 46 Participants |
Secondary
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
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Twinrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Concomitant Medication | Concomitant medication | 151 Participants |
| Twinrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Concomitant Medication | No concomitant medication | 15 Participants |
| Engerix-B+Havrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Concomitant Medication | Concomitant medication | 135 Participants |
| Engerix-B+Havrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Concomitant Medication | No concomitant medication | 10 Participants |
| HB VAX PRO+Vaqta Group | Number of Seroprotected Subjects Against HBs Antigen, by Concomitant Medication | Concomitant medication | 117 Participants |
| HB VAX PRO+Vaqta Group | Number of Seroprotected Subjects Against HBs Antigen, by Concomitant Medication | No concomitant medication | 8 Participants |
Secondary
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
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Twinrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Gender | Females | 82 Participants |
| Twinrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Gender | Males | 84 Participants |
| Engerix-B+Havrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Gender | Females | 73 Participants |
| Engerix-B+Havrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Gender | Males | 72 Participants |
| HB VAX PRO+Vaqta Group | Number of Seroprotected Subjects Against HBs Antigen, by Gender | Females | 75 Participants |
| HB VAX PRO+Vaqta Group | Number of Seroprotected Subjects Against HBs Antigen, by Gender | Males | 50 Participants |
Secondary
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
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Twinrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Medical Condition | Current medical condition | 130 Participants |
| Twinrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Medical Condition | Past medical condition | 13 Participants |
| Twinrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Medical Condition | No medical condition | 23 Participants |
| Engerix-B+Havrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Medical Condition | Current medical condition | 109 Participants |
| Engerix-B+Havrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Medical Condition | No medical condition | 18 Participants |
| Engerix-B+Havrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Medical Condition | Past medical condition | 18 Participants |
| HB VAX PRO+Vaqta Group | Number of Seroprotected Subjects Against HBs Antigen, by Medical Condition | Past medical condition | 12 Participants |
| HB VAX PRO+Vaqta Group | Number of Seroprotected Subjects Against HBs Antigen, by Medical Condition | No medical condition | 13 Participants |
| HB VAX PRO+Vaqta Group | Number of Seroprotected Subjects Against HBs Antigen, by Medical Condition | Current medical condition | 100 Participants |
Secondary
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
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Twinrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Smoking Status | Smokers | 47 Participants |
| Twinrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Smoking Status | Non-smokers | 119 Participants |
| Engerix-B+Havrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Smoking Status | Smokers | 42 Participants |
| Engerix-B+Havrix Group | Number of Seroprotected Subjects Against HBs Antigen, by Smoking Status | Non-smokers | 103 Participants |
| HB VAX PRO+Vaqta Group | Number of Seroprotected Subjects Against HBs Antigen, by Smoking Status | Smokers | 22 Participants |
| HB VAX PRO+Vaqta Group | Number of Seroprotected Subjects Against HBs Antigen, by Smoking Status | Non-smokers | 103 Participants |
Secondary
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)
Population: The analysis was performed on the LT ATP cohort for immunogenicity, which included all subjects who were included in the ATP cohort for immunogenicity in the primary study and who came within the blood sampling time interval at Months 12, 24 and 36.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Twinrix Group | Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen | Anti-HBs, M36 in-house | 104 Participants |
| Twinrix Group | Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen | Anti-HBs, M24 in-house | 125 Participants |
| Twinrix Group | Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen | Anti-HBs, M24 AUSAB | 127 Participants |
| Twinrix Group | Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen | Anti-HBs, M12 AUSAB | 147 Participants |
| Engerix-B+Havrix Group | Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen | Anti-HBs, M12 AUSAB | 124 Participants |
| Engerix-B+Havrix Group | Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen | Anti-HBs, M24 AUSAB | 88 Participants |
| Engerix-B+Havrix Group | Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen | Anti-HBs, M24 in-house | 99 Participants |
| Engerix-B+Havrix Group | Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen | Anti-HBs, M36 in-house | 75 Participants |
| HB VAX PRO+Vaqta Group | Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen | Anti-HBs, M24 in-house | 56 Participants |
| HB VAX PRO+Vaqta Group | Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen | Anti-HBs, M12 AUSAB | 93 Participants |
| HB VAX PRO+Vaqta Group | Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen | Anti-HBs, M24 AUSAB | 50 Participants |
| HB VAX PRO+Vaqta Group | Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen | Anti-HBs, M36 in-house | 45 Participants |
Secondary
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)
Population: The analysis was performed Long Term According-To-Protocol (LT ATP) cohort for immunogenicity, which included all subjects who were included in the ATP cohort for immunogenicity in the primary study and who came within the blood sampling time interval at Months 12, 24 and 36.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HAV, M24 | 164 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HBs, M36 in-house | 124 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HAV, M36 | 158 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HBs, M24 AUSAB | 136 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HAV, M12 | 162 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HBs, M24 in-house | 137 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HBs, M12 AUSAB | 153 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HBs, M36 in-house | 105 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HAV, M12 | 165 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HAV, M24 | 170 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HAV, M36 | 159 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HBs, M12 AUSAB | 134 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HBs, M24 AUSAB | 123 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HBs, M24 in-house | 129 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HBs, M24 AUSAB | 74 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HBs, M12 AUSAB | 109 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HBs, M36 in-house | 67 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HAV, M24 | 163 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HBs, M24 in-house | 76 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HAV, M36 | 148 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HAV, M12 | 164 Participants |
Secondary
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
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age | Anti-HAV, ≤ 50 YOA | 58 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age | Anti-HAV, 51-60 YOA | 63 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age | Anti-HAV, ≥ 61 YOA | 55 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age | Anti-HBs, ≤ 50 YOA | 57 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age | Anti-HBs, 51-60 YOA | 63 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age | Anti-HBs, ≥ 61 YOA | 48 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age | Anti-HBs, ≥ 61 YOA | 44 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age | Anti-HAV, ≤ 50 YOA | 59 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age | Anti-HBs, ≤ 50 YOA | 50 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age | Anti-HBs, 51-60 YOA | 58 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age | Anti-HAV, 51-60 YOA | 63 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age | Anti-HAV, ≥ 61 YOA | 58 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age | Anti-HAV, 51-60 YOA | 57 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age | Anti-HAV, ≥ 61 YOA | 58 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age | Anti-HBs, ≥ 61 YOA | 37 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age | Anti-HBs, ≤ 50 YOA | 54 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age | Anti-HAV, ≤ 50 YOA | 59 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age | Anti-HBs, 51-60 YOA | 46 Participants |
Secondary
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
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption | Anti-HAV, Heavy | 13 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption | Anti-HBs, Heavy | 11 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption | Anti-HBs, Moderate | 52 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption | Anti-HAV, Moderate | 55 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption | Anti-HAV, None or Mild | 108 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption | Anti-HBs, None or Mild | 105 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption | Anti-HBs, Moderate | 57 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption | Anti-HAV, Heavy | 8 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption | Anti-HBs, None or Mild | 89 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption | Anti-HAV, Moderate | 67 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption | Anti-HBs, Heavy | 6 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption | Anti-HAV, None or Mild | 105 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption | Anti-HAV, None or Mild | 100 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption | Anti-HBs, Heavy | 10 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption | Anti-HAV, Heavy | 12 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption | Anti-HAV, Moderate | 62 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption | Anti-HBs, Moderate | 47 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption | Anti-HBs, None or Mild | 80 Participants |
Secondary
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
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI) | Anti-HAV, Healthy | 57 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI) | Anti-HAV, Overweight | 66 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI) | Anti-HAV, Obese | 53 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI) | Anti-HBs, Healthy | 53 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI) | Anti-HBs, Overweight | 62 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI) | Anti-HBs, Obese | 53 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI) | Anti-HBs, Obese | 45 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI) | Anti-HAV, Healthy | 61 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI) | Anti-HBs, Healthy | 54 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI) | Anti-HBs, Overweight | 53 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI) | Anti-HAV, Overweight | 63 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI) | Anti-HAV, Obese | 56 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI) | Anti-HAV, Overweight | 58 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI) | Anti-HAV, Obese | 58 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI) | Anti-HBs, Obese | 45 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI) | Anti-HBs, Healthy | 48 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI) | Anti-HAV, Healthy | 58 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI) | Anti-HBs, Overweight | 44 Participants |
Secondary
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
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication | Anti-HAV, Concomitant medication | 160 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication | Anti-HAV, No concomitant medication | 16 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication | Anti-HBs, No concomitant medication | 15 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication | Anti-HBs, Concomitant medication | 153 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication | Anti-HBs, Concomitant medication | 141 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication | Anti-HAV, Concomitant medication | 167 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication | Anti-HBs, No concomitant medication | 11 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication | Anti-HAV, No concomitant medication | 13 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication | Anti-HAV, No concomitant medication | 14 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication | Anti-HBs, Concomitant medication | 127 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication | Anti-HBs, No concomitant medication | 10 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication | Anti-HAV, Concomitant medication | 160 Participants |
Secondary
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).
Time frame: At Month 7
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender | Anti-HAV, Females | 86 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender | Anti-HAV, Males | 90 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender | Anti-HBs, Females | 82 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender | Anti-HBs, Males | 86 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender | Anti-HBs, Males | 75 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender | Anti-HAV, Females | 88 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender | Anti-HBs, Females | 77 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender | Anti-HAV, Males | 92 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender | Anti-HBs, Males | 59 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender | Anti-HAV, Males | 85 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender | Anti-HBs, Females | 78 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender | Anti-HAV, Females | 89 Participants |
Secondary
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
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition | Anti-HAV,No Medical condition | 24 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition | Anti-HAV,Current Medical condition | 139 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition | Anti-HBs,Current Medical condition | 132 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition | Anti-HAV,Past Medical condition | 13 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition | Anti-HBs,No Medical condition | 23 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition | Anti-HBs,Past Medical condition | 13 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition | Anti-HAV,Past Medical condition | 22 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition | Anti-HAV,No Medical condition | 20 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition | Anti-HAV,Current Medical condition | 138 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition | Anti-HBs,Current Medical condition | 115 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition | Anti-HBs,Past Medical condition | 18 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition | Anti-HBs,No Medical condition | 19 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition | Anti-HBs,Past Medical condition | 12 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition | Anti-HBs,Current Medical condition | 110 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition | Anti-HAV,No Medical condition | 20 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition | Anti-HAV,Past Medical condition | 15 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition | Anti-HAV,Current Medical condition | 139 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition | Anti-HBs,No Medical condition | 15 Participants |
Secondary
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
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status | Anti-HAV, Smokers | 50 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status | Anti-HAV, Non-smokers | 126 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status | Anti-HBs, Smokers | 47 Participants |
| Twinrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status | Anti-HBs, Non-smokers | 121 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status | Anti-HBs, Non-smokers | 108 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status | Anti-HAV, Smokers | 51 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status | Anti-HBs, Smokers | 44 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status | Anti-HAV, Non-smokers | 129 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status | Anti-HBs, Non-smokers | 114 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status | Anti-HAV, Non-smokers | 142 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status | Anti-HBs, Smokers | 23 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status | Anti-HAV, Smokers | 32 Participants |
Secondary
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)
Population: The analysis was performed on the Long Term Total Vaccinated Cohort, which included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the current blood sample time point at one, two and three years (Month 12, 24, 36) after first vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Twinrix Group | Number of Subjects With SAEs | Any SAE(s), M36 | 0 Participants |
| Twinrix Group | Number of Subjects With SAEs | Any SAE(s), M12 | 0 Participants |
| Twinrix Group | Number of Subjects With SAEs | Any SAE(s), M24 | 0 Participants |
| Engerix-B+Havrix Group | Number of Subjects With SAEs | Any SAE(s), M24 | 0 Participants |
| Engerix-B+Havrix Group | Number of Subjects With SAEs | Any SAE(s), M36 | 0 Participants |
| Engerix-B+Havrix Group | Number of Subjects With SAEs | Any SAE(s), M12 | 0 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With SAEs | Any SAE(s), M12 | 0 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With SAEs | Any SAE(s), M36 | 0 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With SAEs | Any SAE(s), M24 | 0 Participants |
Secondary
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
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Twinrix Group | Number of Subjects With Serious Adverse Events (SAEs) | 11 Participants |
| Engerix-B+Havrix Group | Number of Subjects With Serious Adverse Events (SAEs) | 14 Participants |
| HB VAX PRO+Vaqta Group | Number of Subjects With Serious Adverse Events (SAEs) | 16 Participants |