| Primary | Antibody Concentrations for Anti-hepatitis A Virus (Anti-HAV) and Anti-hepatitis B Surface (Anti-HBs) Antigens | Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Month 7 after Twinrix vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | | Title | Denominators | Categories |
|---|
| Anti-HAV | | | Title | Measurements |
|---|
| - OG0002746.5(2256.3 to 3343.2)
|
| | Anti-HBs | | | Title | Measurements |
|---|
| - OG0001153.9(829.8 to 1604.7)
|
|
| |
| Primary | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration ≥ 15mIU/mL; seropositivity for anti-HBs antibodies was defined as anti-HBs antibody concentration ≥ 3.3 mIU/mL. | 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. | Posted | | Count of Participants | | Participants | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | HB VAX PRO+Vaqta Group | |
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| Primary | Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen | A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. | 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. | Posted | | Count of Participants | | Participants | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender | Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. The seropositivity rates were stratified by gender (females and males). | 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. | Posted | | Count of Participants | | Participants | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 |
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| Secondary | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age | Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. The seropositivity rates were stratified by age as follows: ≤ 50 years of age (YOA), 51-60 YOA and ≥ 61 YOA. | 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. | Posted | | Count of Participants | | Participants | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 |
|
| Secondary | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI) | Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. The seropositivity rates were stratified by BMI as follows: healthy, overweight and obese. | 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. | Posted | | Count of Participants | | Participants | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 |
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| Secondary | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status | Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. The seropositivity rates were stratified by smoking status (smokers and non-smokers). | 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. | Posted | | Count of Participants | | Participants | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 |
|
| Secondary | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption | Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. The seropositivity rates were stratified by alcohol consumption as follows: None or Mild, Moderate and Heavy. | 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. | Posted | | Count of Participants | | Participants | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | |
|
| Secondary | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication | Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. The seropositivity rates were stratified by concomitant medication (concomitant medication and no concomitant medication). | 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. | Posted | | Count of Participants | | Participants | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | |
|
| Secondary | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition | Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. The seropositivity rates were stratified by medical condition as follows: no medical condition, past medical condition and current medical condition. | 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. | Posted | | Count of Participants | | Participants | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Seroprotected Subjects Against HBs Antigen, by Gender | A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. The seroprotection rates were stratified by gender (females and males). | 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. | Posted | | Count of Participants | | Participants | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | HB VAX PRO+Vaqta Group | |
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| Secondary | Number of Seroprotected Subjects Against HBs Antigen, by Age | A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. The seroprotection rates were stratified by age as follows: ≤ 50 years of age (YOA), 51-60 YOA and ≥ 61 YOA. | 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. | Posted | | Count of Participants | | Participants | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | HB VAX PRO+Vaqta Group |
|
| Secondary | Number of Seroprotected Subjects Against HBs Antigen, by BMI | A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. The seroprotection rates were stratified by BMI as follows: healthy, overweight and obese. | 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. | Posted | | Count of Participants | | Participants | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | HB VAX PRO+Vaqta Group | |
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| Secondary | Number of Seroprotected Subjects Against HBs Antigen, by Smoking Status | A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. The seroprotection rates were stratified by smoking status (smokers and non-smokers). | 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. | Posted | | Count of Participants | | Participants | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | HB VAX PRO+Vaqta Group |
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| Secondary | Number of Seroprotected Subjects Against HBs Antigen, by Alcohol Consumption | A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. The seroprotection rates were stratified by alcohol consumption as follows: none or mild, moderate and heavy. | 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. | Posted | | Count of Participants | | Participants | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | HB VAX PRO+Vaqta Group |
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| Secondary | Number of Seroprotected Subjects Against HBs Antigen, by Concomitant Medication | A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. The seroprotection rates were stratified by concomitant medication (concomitant medication and no concomitant medication). | 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. | Posted | | Count of Participants | | Participants | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | HB VAX PRO+Vaqta Group |
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| Secondary | Number of Seroprotected Subjects Against HBs Antigen, by Medical Condition | A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. The seroprotection rates were stratified by medical condition as follows: no medical condition, past medical condition and current medical condition. | 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. | Posted | | Count of Participants | | Participants | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | HB VAX PRO+Vaqta Group |
|
| Secondary | Anti-HAV and Anti-HBs Antibody Concentrations, by Gender | Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively. The antibody concentrations were stratified by gender (females and males). | 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. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | |
|
| Secondary | Anti-HAV and Anti-HBs Antibody Concentrations, by Age | Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively. The antibody concentrations were stratified by age as follows: ≤ 50 years of age (YOA), 51-60 YOA and ≥ 61 YOA. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Anti-HAV and Anti-HBs Antibody Concentrations, by BMI | Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively. The antibody concentrations were stratified by BMI as follows: healthy, overweight and obese. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status | Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively. The antibody concentrations were stratified by smoking status (smokers and non-smokers). | 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. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption | Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively. The antibody concentrations were stratified by alcohol consumption as follows: none or mild, moderate and heavy. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication | Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively. The antibody concentrations were stratified by concomitant medication (concomitant medication and no concomitant medication). | 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. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Month 7 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition | Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively. The antibody concentrations were stratified by medical condition as follows: no medical condition, past medical condition and current medical condition. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Month 7 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value | Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. Anti-HBs AUSAB = anti-HBs antibody concentrations were tested with AUSAB EIA /Abbott assay; Anti-HBs in-house = anti-HBs antibody concentrations were tested with in-house assay (bridging). | 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. | Posted | | Count of Participants | | Participants | | At Month 12 (M12), Month 24 (M24) and Month 36 (M36) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen | A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. Anti-HBs AUSAB = anti-HBs antibody concentrations were tested with AUSAB EIA /Abbott assay; Anti-HBs in-house = anti-HBs antibody concentrations were tested with in-house assay (bridging). | 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. | Posted | | Count of Participants | | Participants | | At Month 12 (M12), Month 24 (M24) and Month 36 (M36) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Anti-HAV and Anti-HBs Antibody Concentrations | Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively. Anti-HBs AUSAB = anti-HBs antibody concentrations were tested with AUSAB EIA /Abbott assay; Anti-HBs in-house = anti-HBs antibody concentrations were tested with in-house assay (bridging). | 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. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Month 12 (M12), Month 24 (M24) and Month 36 (M36) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: 3 subjects reported SAEs prior to administration of the first dose of vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Posted | | Count of Participants | | Participants | | From Day 0 up to Month 7 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | HB VAX PRO+Vaqta Group | |
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| Secondary | Number of Subjects With SAEs | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: 3 subjects reported SAEs prior to administration of the first dose of vaccination. | 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. | Posted | | Count of Participants | | Participants | | At Month 12 (M12), Month 24 (M24) and Month 36 (M36) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | |
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