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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00289731
Collaborator
(none)
596
9
3
12.9
66.2
5.1

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
  • Biological: TWINRIX™
  • Biological: Engerix™-B
  • Biological: HAVRIX™
  • Biological: HB VAX PRO™
  • Biological: Vaqta™
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

Study Type:
Interventional
Actual Enrollment :
596 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Evaluate the Effect of Several Risk Factors That Are Likely to Influence the Immunogenicity of GSK Biologicals' Combined Hepatitis A & B Vaccine, vs Separately Administered Monovalent Hepatitis A and Hepatitis B Vaccines
Actual Study Start Date :
Nov 24, 2003
Actual Primary Completion Date :
Dec 21, 2004
Actual Study Completion Date :
Dec 21, 2004

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

  1. 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.

  2. 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.

  3. 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

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. 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).

  8. 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.

  9. 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).

  10. 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.

  11. 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.

  12. 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).

  13. 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.

  14. 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).

  15. 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.

  16. 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).

  17. 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.

  18. 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.

  19. 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).

  20. 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.

  21. 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).

  22. 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.

  23. 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).

  24. 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).

  25. 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).

  26. 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.

  27. 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

Ages Eligible for Study:
41 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion criteria:
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.

  • Healthy and non-healthy male or female aged 41 years or older at the time of the first vaccination.

  • Written informed consent obtained from the subject.

  • No serological signs of hepatitis A or B infection at screening.

  • If the subject is female, she must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion criteria:
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.

  • History of any hepatitis A or hepatitis B vaccination or infection, since the primary vaccination study 100382.

  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

  • Acute disease at the time of enrolment. .

  • Pregnant or lactating female.

  • Female planning to become pregnant or planning to discontinue contraceptive precautions during the primary vaccination period.

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

Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00289731
Other Study ID Numbers:
  • 100382
  • 100383
  • 100384
  • 100385
First Posted:
Feb 10, 2006
Last Update Posted:
Nov 15, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:

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

1. Primary Outcome
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
2. Primary Outcome
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
3. Primary Outcome
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
4. Secondary Outcome
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
5. Secondary Outcome
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%
6. Secondary Outcome
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%
7. Secondary Outcome
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%
8. Secondary Outcome
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%
9. Secondary Outcome
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%
10. Secondary Outcome
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%
11. Secondary Outcome
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%
12. Secondary Outcome
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%
13. Secondary Outcome
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%
14. Secondary Outcome
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%
15. Secondary Outcome
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%
16. Secondary Outcome
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%
17. Secondary Outcome
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%
18. Secondary Outcome
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%
19. Secondary Outcome
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
20. Secondary Outcome
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
21. Secondary Outcome
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
22. Secondary Outcome
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
23. Secondary Outcome
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
24. Secondary Outcome
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
25. Secondary Outcome
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
26. Secondary Outcome
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%
27. Secondary Outcome
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%
28. Secondary Outcome
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
29. Secondary Outcome
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%
30. Secondary Outcome
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

[Not Specified]

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
Email
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00289731
Other Study ID Numbers:
  • 100382
  • 100383
  • 100384
  • 100385
First Posted:
Feb 10, 2006
Last Update Posted:
Nov 15, 2019
Last Verified:
Oct 1, 2019