Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Detailed Description
The study will also evaluate the persistence of hepatitis A and hepatitis B antibodies at months 12, 24 and 36 after the first dose of primary vaccination course.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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. |
Biological: TWINRIX™
Intramuscular injection, 3 doses
|
Active Comparator: 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. |
Biological: Engerix™-B
Intramuscular injection, 3 doses
Biological: HAVRIX™
Intramuscular injection, 2 doses
|
Active Comparator: 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. |
Biological: HB VAX PRO™
Intramuscular injection, 3 doses
Biological: Vaqta™
Intramuscular injection, 2 doses
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
Secondary Outcome Measures
- 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.
- 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).
- 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.
- 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).
- 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 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | GSK Investigational Site | Wilrijk | Belgium | 2610 | |
2 | GSK Investigational Site | Hradec Kralove | Czechia | 500 01 | |
3 | GSK Investigational Site | Finsterwalde | Brandenburg | Germany | 03238 |
4 | GSK Investigational Site | Dresden | Sachsen | Germany | 01129 |
5 | GSK Investigational Site | Geringswalde | Sachsen | Germany | 09326 |
6 | GSK Investigational Site | Pirna | Sachsen | Germany | 01796 |
7 | GSK Investigational Site | Bad Bramstedt | Schleswig-Holstein | Germany | 24576 |
8 | GSK Investigational Site | Bad Segeberg | Schleswig-Holstein | Germany | 23795 |
9 | GSK Investigational Site | Elmshorn | Schleswig-Holstein | Germany | 25335 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 100382
- 100383
- 100384
- 100385
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | 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. |
Arm/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Period Title: Overall Study | |||
STARTED | 199 | 200 | 197 |
COMPLETED | 197 | 198 | 195 |
NOT COMPLETED | 2 | 2 | 2 |
Baseline Characteristics
Arm/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group | Total |
---|---|---|---|---|
Arm/Group Description | 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. | 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. | 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. | Total of all reporting groups |
Overall Participants | 199 | 200 | 197 | 596 |
Age (Years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [Years] |
55.2
(9.24)
|
55.3
(9.91)
|
55.0
(9.64)
|
55.17
(9.59)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
97
48.7%
|
100
50%
|
101
51.3%
|
298
50%
|
Male |
102
51.3%
|
100
50%
|
96
48.7%
|
298
50%
|
Race/Ethnicity, Customized (Count of Participants) | ||||
Caucasian |
199
100%
|
200
100%
|
196
99.5%
|
595
99.8%
|
Black |
0
0%
|
0
0%
|
1
0.5%
|
1
0.2%
|
Outcome Measures
Title | Antibody Concentrations for Anti-hepatitis A Virus (Anti-HAV) and Anti-hepatitis B Surface (Anti-HBs) Antigens |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group |
---|---|
Arm/Group Description | 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. |
Measure Participants | 181 |
Anti-HAV |
2746.5
|
Anti-HBs |
1153.9
|
Title | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 181 | 182 | 176 |
Anti-HAV |
176
88.4%
|
180
90%
|
174
88.3%
|
Anti-HBs |
168
84.4%
|
152
76%
|
137
69.5%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Twinrix Group, Engerix-B+Havrix Group |
---|---|---|
Comments | 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. | |
Type of Statistical Test | Non-Inferiority | |
Comments | Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus Engerix-B+Havrix Group), in terms of seropositivity rates for anti-HAV antibody, being - 10%. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in seropositivity rate |
Estimated Value | -1.66 | |
Confidence Interval |
(2-Sided) 95% -5.34 to 1.48 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Twinrix Group, HB VAX PRO+Vaqta Group |
---|---|---|
Comments | 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. | |
Type of Statistical Test | Non-Inferiority | |
Comments | Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus HB VAX PRO+Vaqta Group), in terms of seropositivity rates for anti-HAV antibody, being - 10%. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in seropositivity rate |
Estimated Value | -1.63 | |
Confidence Interval |
(2-Sided) 95% -5.31 to 1.60 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 181 | 182 | 176 |
Count of Participants [Participants] |
166
83.4%
|
145
72.5%
|
125
63.5%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Twinrix Group, Engerix-B+Havrix Group |
---|---|---|
Comments | 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. | |
Type of Statistical Test | Non-Inferiority | |
Comments | Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus Engerix-B+Havrix Group), in terms of seroprotection rates for anti-HBs antibody, being - 10%. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in seroprotection rate |
Estimated Value | 12.04 | |
Confidence Interval |
(2-Sided) 95% 4.97 to 19.35 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Twinrix Group, HB VAX PRO+Vaqta Group |
---|---|---|
Comments | 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. | |
Type of Statistical Test | Non-Inferiority | |
Comments | Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus HB VAX PRO+Vaqta Group), in terms of seroprotection rates for anti-HBs antibody, being - 15%. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in seroprotection rates |
Estimated Value | 20.69 | |
Confidence Interval |
(2-Sided) 95% 12.92 to 28.62 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Anti-HAV and Anti-HBs Antibody Concentrations |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 168 | 165 |
Anti-HAV |
1394.3
|
3707.2
|
Anti-HBs |
491.2
|
179.1
|
Title | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 181 | 182 | 176 |
Anti-HAV, Females |
86
43.2%
|
88
44%
|
89
45.2%
|
Anti-HAV, Males |
90
45.2%
|
92
46%
|
85
43.1%
|
Anti-HBs, Females |
82
41.2%
|
77
38.5%
|
78
39.6%
|
Anti-HBs, Males |
86
43.2%
|
75
37.5%
|
59
29.9%
|
Title | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 181 | 182 | 176 |
Anti-HAV, ≤ 50 YOA |
58
29.1%
|
59
29.5%
|
59
29.9%
|
Anti-HAV, 51-60 YOA |
63
31.7%
|
63
31.5%
|
57
28.9%
|
Anti-HAV, ≥ 61 YOA |
55
27.6%
|
58
29%
|
58
29.4%
|
Anti-HBs, ≤ 50 YOA |
57
28.6%
|
50
25%
|
54
27.4%
|
Anti-HBs, 51-60 YOA |
63
31.7%
|
58
29%
|
46
23.4%
|
Anti-HBs, ≥ 61 YOA |
48
24.1%
|
44
22%
|
37
18.8%
|
Title | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI) |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 181 | 182 | 176 |
Anti-HAV, Healthy |
57
28.6%
|
61
30.5%
|
58
29.4%
|
Anti-HAV, Overweight |
66
33.2%
|
63
31.5%
|
58
29.4%
|
Anti-HAV, Obese |
53
26.6%
|
56
28%
|
58
29.4%
|
Anti-HBs, Healthy |
53
26.6%
|
54
27%
|
48
24.4%
|
Anti-HBs, Overweight |
62
31.2%
|
53
26.5%
|
44
22.3%
|
Anti-HBs, Obese |
53
26.6%
|
45
22.5%
|
45
22.8%
|
Title | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 181 | 182 | 176 |
Anti-HAV, Smokers |
50
25.1%
|
51
25.5%
|
32
16.2%
|
Anti-HAV, Non-smokers |
126
63.3%
|
129
64.5%
|
142
72.1%
|
Anti-HBs, Smokers |
47
23.6%
|
44
22%
|
23
11.7%
|
Anti-HBs, Non-smokers |
121
60.8%
|
108
54%
|
114
57.9%
|
Title | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 181 | 182 | 176 |
Anti-HAV, None or Mild |
108
54.3%
|
105
52.5%
|
100
50.8%
|
Anti-HAV, Moderate |
55
27.6%
|
67
33.5%
|
62
31.5%
|
Anti-HAV, Heavy |
13
6.5%
|
8
4%
|
12
6.1%
|
Anti-HBs, None or Mild |
105
52.8%
|
89
44.5%
|
80
40.6%
|
Anti-HBs, Moderate |
52
26.1%
|
57
28.5%
|
47
23.9%
|
Anti-HBs, Heavy |
11
5.5%
|
6
3%
|
10
5.1%
|
Title | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 181 | 182 | 176 |
Anti-HAV, Concomitant medication |
160
80.4%
|
167
83.5%
|
160
81.2%
|
Anti-HAV, No concomitant medication |
16
8%
|
13
6.5%
|
14
7.1%
|
Anti-HBs, Concomitant medication |
153
76.9%
|
141
70.5%
|
127
64.5%
|
Anti-HBs, No concomitant medication |
15
7.5%
|
11
5.5%
|
10
5.1%
|
Title | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 181 | 182 | 176 |
Anti-HAV,No Medical condition |
24
12.1%
|
20
10%
|
20
10.2%
|
Anti-HAV,Past Medical condition |
13
6.5%
|
22
11%
|
15
7.6%
|
Anti-HAV,Current Medical condition |
139
69.8%
|
138
69%
|
139
70.6%
|
Anti-HBs,No Medical condition |
23
11.6%
|
19
9.5%
|
15
7.6%
|
Anti-HBs,Past Medical condition |
13
6.5%
|
18
9%
|
12
6.1%
|
Anti-HBs,Current Medical condition |
132
66.3%
|
115
57.5%
|
110
55.8%
|
Title | Number of Seroprotected Subjects Against HBs Antigen, by Gender |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 181 | 182 | 176 |
Females |
82
41.2%
|
73
36.5%
|
75
38.1%
|
Males |
84
42.2%
|
72
36%
|
50
25.4%
|
Title | Number of Seroprotected Subjects Against HBs Antigen, by Age |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 181 | 182 | 176 |
≤ 50 YOA |
57
28.6%
|
48
24%
|
52
26.4%
|
51-60 YOA |
63
31.7%
|
55
27.5%
|
43
21.8%
|
≥ 61 YOA |
46
23.1%
|
42
21%
|
30
15.2%
|
Title | Number of Seroprotected Subjects Against HBs Antigen, by BMI |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 181 | 182 | 176 |
Healthy |
52
26.1%
|
51
25.5%
|
46
23.4%
|
Overweight |
62
31.2%
|
51
25.5%
|
40
20.3%
|
Obese |
52
26.1%
|
43
21.5%
|
39
19.8%
|
Title | Number of Seroprotected Subjects Against HBs Antigen, by Smoking Status |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 181 | 182 | 176 |
Smokers |
47
23.6%
|
42
21%
|
22
11.2%
|
Non-smokers |
119
59.8%
|
103
51.5%
|
103
52.3%
|
Title | Number of Seroprotected Subjects Against HBs Antigen, by Alcohol Consumption |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 181 | 182 | 176 |
None or Mild |
105
52.8%
|
87
43.5%
|
76
38.6%
|
Moderate |
50
25.1%
|
52
26%
|
41
20.8%
|
Heavy |
11
5.5%
|
6
3%
|
8
4.1%
|
Title | Number of Seroprotected Subjects Against HBs Antigen, by Concomitant Medication |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 181 | 182 | 176 |
Concomitant medication |
151
75.9%
|
135
67.5%
|
117
59.4%
|
No concomitant medication |
15
7.5%
|
10
5%
|
8
4.1%
|
Title | Number of Seroprotected Subjects Against HBs Antigen, by Medical Condition |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 181 | 182 | 176 |
No medical condition |
23
11.6%
|
18
9%
|
13
6.6%
|
Past medical condition |
13
6.5%
|
18
9%
|
12
6.1%
|
Current medical condition |
130
65.3%
|
109
54.5%
|
100
50.8%
|
Title | Anti-HAV and Anti-HBs Antibody Concentrations, by Gender |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 181 | 182 | 176 |
Anti-HAV, Females |
2968.1
|
2089.2
|
5307.0
|
Anti-HAV, Males |
2550.3
|
947.0
|
2546.4
|
Anti-HBs, Females |
1957.5
|
474.2
|
273.8
|
Anti-HBs, Males |
697.1
|
509.4
|
102.2
|
Title | Anti-HAV and Anti-HBs Antibody Concentrations, by Age |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 181 | 182 | 176 |
Anti-HAV, ≤ 50 YOA |
4034.0
|
1769.8
|
5166.9
|
Anti-HAV, 51-60 YOA |
2521.6
|
1714.8
|
3822.8
|
Anti-HAV, ≥ 61 YOA |
2019.4
|
873.8
|
2566.2
|
Anti-HBs, ≤ 50 YOA |
1839.9
|
753.7
|
217.2
|
Anti-HBs, 51-60 YOA |
986.4
|
324.1
|
286.6
|
Anti-HBs, ≥ 61 YOA |
814.6
|
522.6
|
75.3
|
Title | Anti-HAV and Anti-HBs Antibody Concentrations, by BMI |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 181 | 182 | 176 |
Anti-HAV, Healthy |
3565.4
|
1569.2
|
4756.2
|
Anti-HAV, Overweight |
2846.6
|
1663.9
|
3943.9
|
Anti-HAV, Obese |
1984.0
|
1004.8
|
2716.2
|
Anti-HBs, Healthy |
2140.5
|
505.4
|
475.2
|
Anti-HBs, Overweight |
1540.8
|
609.4
|
165.9
|
Anti-HBs, Obese |
443.5
|
368.3
|
68.1
|
Title | Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 181 | 182 | 176 |
Anti-HAV, Smokers |
1844.6
|
1433.2
|
3456.0
|
Anti-HAV, Non-Smokers |
3216.5
|
1379.2
|
3766.3
|
Anti-HBs, Smokers |
654.4
|
416.4
|
108.1
|
Anti-HBs, Non-smokers |
1438.3
|
525.5
|
198.3
|
Title | Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 181 | 182 | 176 |
Anti-HAV, None or Mild |
2505.1
|
1403.6
|
3731.1
|
Anti-HAV, Moderate |
3174.6
|
1453.8
|
3754.3
|
Anti-HAV, Heavy |
3195.3
|
899.8
|
3292.6
|
Anti-HBs, None or Mild |
1043.1
|
534.9
|
230.7
|
Anti-HBs, Moderate |
1136.7
|
467.3
|
132.7
|
Anti-HBs, Heavy |
3246.9
|
223.4
|
96.6
|
Title | Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 165 | 169 | 162 |
Anti-HAV, concomitant medication |
2680.3
|
1398.4
|
3752.7
|
Anti-HAV, no concomitant medication |
3505.5
|
1343.0
|
3225.1
|
Anti-HBs, concomitant medication |
1138.0
|
533.4
|
174.1
|
Anti-HBs, no concomitant medication |
1329.9
|
170.8
|
255.8
|
Title | Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 181 | 182 | 176 |
Anti-HAV,no medical condition |
4765.5
|
2187.5
|
5531.9
|
Anti-HAV,past medical condition |
3438.3
|
1882.2
|
4073.9
|
Anti-HAV,current medical condition |
2445.3
|
1245.2
|
3464.3
|
Anti-HBs,no medical condition |
2743.4
|
435.2
|
345.1
|
Anti-HBs,past medical condition |
1537.3
|
799.5
|
349.4
|
Anti-HBs,current medical condition |
964.6
|
464.4
|
152.2
|
Title | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value |
---|---|
Description | 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) |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 171 | 176 | 167 |
Anti-HAV, M12 |
162
81.4%
|
165
82.5%
|
164
83.2%
|
Anti-HAV, M24 |
164
82.4%
|
170
85%
|
163
82.7%
|
Anti-HAV, M36 |
158
79.4%
|
159
79.5%
|
148
75.1%
|
Anti-HBs, M12 AUSAB |
153
76.9%
|
134
67%
|
109
55.3%
|
Anti-HBs, M24 AUSAB |
136
68.3%
|
123
61.5%
|
74
37.6%
|
Anti-HBs, M24 in-house |
137
68.8%
|
129
64.5%
|
76
38.6%
|
Anti-HBs, M36 in-house |
124
62.3%
|
105
52.5%
|
67
34%
|
Title | Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen |
---|---|
Description | 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) |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 171 | 176 | 167 |
Anti-HBs, M12 AUSAB |
147
73.9%
|
124
62%
|
93
47.2%
|
Anti-HBs, M24 AUSAB |
127
63.8%
|
88
44%
|
50
25.4%
|
Anti-HBs, M24 in-house |
125
62.8%
|
99
49.5%
|
56
28.4%
|
Anti-HBs, M36 in-house |
104
52.3%
|
75
37.5%
|
45
22.8%
|
Title | Anti-HAV and Anti-HBs Antibody Concentrations |
---|---|
Description | 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) |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 171 | 176 | 167 |
Anti-HAV, M12 |
891.0
|
530.6
|
1200.5
|
Anti-HAV, M24 |
271.6
|
209.9
|
362.0
|
Anti-HAV, M36 |
216.9
|
185.4
|
278.5
|
Anti-HBs, M12 AUSAB |
339.2
|
149.4
|
53.1
|
Anti-HBs, M24 AUSAB |
113.2
|
46.5
|
21.3
|
Anti-HBs, M24 in-house |
99.3
|
40.8
|
22.3
|
Anti-HBs, M36 in-house |
72.1
|
34.1
|
18.9
|
Title | Number of Subjects With Serious Adverse Events (SAEs) |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. |
Arm/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 199 | 200 | 197 |
Count of Participants [Participants] |
11
5.5%
|
14
7%
|
16
8.1%
|
Title | Number of Subjects With SAEs |
---|---|
Description | 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) |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 197 | 198 | 194 |
Any SAE(s), M12 |
0
0%
|
0
0%
|
0
0%
|
Any SAE(s), M24 |
0
0%
|
0
0%
|
0
0%
|
Any SAE(s), M36 |
0
0%
|
0
0%
|
0
0%
|
Adverse Events
Time Frame | SAEs: from Day 0 up to Month 36. | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | Only SAEs were collected during this study. Per Study Protocol, Other (non-serious) Adverse Events were not planned to be collected in this study. | |||||
Arm/Group Title | Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group | |||
Arm/Group Description | 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. | 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. | 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. | |||
All Cause Mortality |
||||||
Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/199 (0.5%) | 2/200 (1%) | 2/197 (1%) | |||
Serious Adverse Events |
||||||
Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 11/199 (5.5%) | 14/200 (7%) | 16/197 (8.1%) | |||
Blood and lymphatic system disorders | ||||||
Anaemia | 1/199 (0.5%) | 0/200 (0%) | 0/197 (0%) | |||
Gastroduodenal ulcer | 1/199 (0.5%) | 0/200 (0%) | 0/197 (0%) | |||
Cardiac disorders | ||||||
Adams-Stokes syndrome | 1/199 (0.5%) | 0/200 (0%) | 0/197 (0%) | |||
Angina pectoris | 0/199 (0%) | 0/200 (0%) | 1/197 (0.5%) | |||
Atrial fibrillation | 1/199 (0.5%) | 0/200 (0%) | 0/197 (0%) | |||
Cardiac arrest | 0/199 (0%) | 1/200 (0.5%) | 0/197 (0%) | |||
Coronary artery occlusion | 0/199 (0%) | 1/200 (0.5%) | 0/197 (0%) | |||
Eye disorders | ||||||
Angle closure glaucoma | 0/199 (0%) | 0/200 (0%) | 1/197 (0.5%) | |||
Blepharochalasis | 0/199 (0%) | 0/200 (0%) | 1/197 (0.5%) | |||
Cataract | 1/199 (0.5%) | 0/200 (0%) | 0/197 (0%) | |||
Glaucoma | 0/199 (0%) | 0/200 (0%) | 1/197 (0.5%) | |||
Gastrointestinal disorders | ||||||
Gastric ulcer haemorrhage | 1/199 (0.5%) | 0/200 (0%) | 0/197 (0%) | |||
Ileus | 1/199 (0.5%) | 0/200 (0%) | 0/197 (0%) | |||
Inguinal hernia | 1/199 (0.5%) | 1/200 (0.5%) | 0/197 (0%) | |||
Hepatobiliary disorders | ||||||
Cholecystitis | 0/199 (0%) | 0/200 (0%) | 1/197 (0.5%) | |||
Cholelithiasis | 0/199 (0%) | 1/200 (0.5%) | 1/197 (0.5%) | |||
Hepatic cirrhosis | 0/199 (0%) | 1/200 (0.5%) | 0/197 (0%) | |||
Hepatic neoplasm malignant | 0/199 (0%) | 1/200 (0.5%) | 0/197 (0%) | |||
Infections and infestations | ||||||
Pneumonia | 0/199 (0%) | 0/200 (0%) | 2/197 (1%) | |||
Cystitis | 0/199 (0%) | 1/200 (0.5%) | 0/197 (0%) | |||
Meningitis | 1/199 (0.5%) | 0/200 (0%) | 0/197 (0%) | |||
Pyelonephritis | 0/199 (0%) | 1/200 (0.5%) | 0/197 (0%) | |||
Viral infection | 0/199 (0%) | 1/200 (0.5%) | 0/197 (0%) | |||
Injury, poisoning and procedural complications | ||||||
Hand fracture | 0/199 (0%) | 1/200 (0.5%) | 0/197 (0%) | |||
Lower limb fracture | 1/199 (0.5%) | 1/200 (0.5%) | 0/197 (0%) | |||
Meniscus lesion | 0/199 (0%) | 1/200 (0.5%) | 0/197 (0%) | |||
Tibia fracture | 0/199 (0%) | 0/200 (0%) | 1/197 (0.5%) | |||
Investigations | ||||||
Weight decreased | 0/199 (0%) | 1/200 (0.5%) | 0/197 (0%) | |||
Musculoskeletal and connective tissue disorders | ||||||
Osteoarthritis | 0/199 (0%) | 0/200 (0%) | 1/197 (0.5%) | |||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
Breast cancer female | 0/199 (0%) | 0/200 (0%) | 1/197 (0.5%) | |||
Lung neoplasm malignant | 0/199 (0%) | 0/200 (0%) | 1/197 (0.5%) | |||
Nervous system disorders | ||||||
Carotid artery stenosis | 0/199 (0%) | 0/200 (0%) | 1/197 (0.5%) | |||
Dizziness | 0/199 (0%) | 1/200 (0.5%) | 1/197 (0.5%) | |||
Epilepsy | 1/199 (0.5%) | 0/200 (0%) | 0/197 (0%) | |||
Myasthenia gravis | 1/199 (0.5%) | 0/200 (0%) | 0/197 (0%) | |||
Paraesthesia | 0/199 (0%) | 0/200 (0%) | 1/197 (0.5%) | |||
Subdural haematoma | 1/199 (0.5%) | 0/200 (0%) | 0/197 (0%) | |||
Transient ischaemic attack | 0/199 (0%) | 1/200 (0.5%) | 0/197 (0%) | |||
Renal and urinary disorders | ||||||
Renal colic | 1/199 (0.5%) | 0/200 (0%) | 0/197 (0%) | |||
Stress incontinence | 0/199 (0%) | 0/200 (0%) | 1/197 (0.5%) | |||
Respiratory, thoracic and mediastinal disorders | ||||||
Nasal cyst | 0/199 (0%) | 0/200 (0%) | 1/197 (0.5%) | |||
Pulmonary embolism | 0/199 (0%) | 1/200 (0.5%) | 0/197 (0%) | |||
Skin and subcutaneous tissue disorders | ||||||
Dermatitis allergic | 0/199 (0%) | 1/200 (0.5%) | 0/197 (0%) | |||
Vascular disorders | ||||||
Varicose vein | 0/199 (0%) | 0/200 (0%) | 1/197 (0.5%) | |||
Other (Not Including Serious) Adverse Events |
||||||
Twinrix Group | Engerix-B+Havrix Group | HB VAX PRO+Vaqta Group | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title | GSK Response Center |
---|---|
Organization | GlaxoSmithKline |
Phone | 866-435-7343 |
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