Hepatitis A, Hepatitis B
Conditions
Keywords
Hepatitis B, TWINRIX™ Adult, Hepatitis A, TWINRIX™ Junior
Brief summary
To evaluate the persistence of anti-hepatitis A virus (anti-HAV) and anti-hepatitis B surface antigen (anti-HBs) antibodies up to 6, 7, 8, 9 and 10 years after administration of the first dose of the study vaccine.
Detailed description
Open, randomized, long-term antibody persistence studies. Immune persistence was compared between subjects who received one of the two formulations of GlaxoSmithKline Biologicals' combined hepatitis A and hepatitis B vaccine according to a two-dose or three-dose schedule. These long-term follow-up studies involved taking blood samples at approximately 6, 7, 8, 9 and 10 years after the primary vaccination of combined hepatitis A and B vaccine, to assess antibody persistence and a retrospective safety follow-up. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALTwinrix™ Adult
Intramuscular administration in the deltoid region (2 doses).
BIOLOGICALTwinrix™ Junior
Intramuscular administration in the deltoid region (3 doses).
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female volunteers vaccinated in study HAB-084. * Written informed consent obtained from the subject before the blood sampling visit of each year.
Exclusion criteria
• none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value | Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination | Anti-HAV antibody concentration cut-off value assessed was ≥ 15 milli-International Units per milliliter (mIU/mL). |
| Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value | Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination | Anti-HBs antibody concentration cut-off value assessed was ≥ 3.3 mIU/mL. |
| Serious Adverse Events (SAE) Causally Related to Primary Vaccination or Related to Hepatitis A or B Infection or Related to Study Participation (Blood Sampling) | From Year 6 through to Year 10 | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. |
Countries
Belgium, Czechia
Participant flow
Recruitment details
At the time of initiation of the long-term follow-up study, the investigators contacted the subjects who had consented to participate in the long-term follow-up studies. At each subsequent visit, subjects who were present at the previous long-term blood sampling time points were contacted again.
Participants by arm
| Arm | Count |
|---|---|
| Group Twinrix Junior Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study. | 126 |
| Group Twinrix Adult Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study. | 118 |
| Total | 244 |
Baseline characteristics
| Characteristic | Group Twinrix Junior | Group Twinrix Adult | Total |
|---|---|---|---|
| Age, Continuous | 19.4 years STANDARD_DEVIATION 1.04 | 19.4 years STANDARD_DEVIATION 1.12 | 19.4 years STANDARD_DEVIATION 1.08 |
| Sex: Female, Male Female | 62 Participants | 61 Participants | 123 Participants |
| Sex: Female, Male Male | 64 Participants | 57 Participants | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 126 | 0 / 118 |
| serious Total, serious adverse events | 0 / 126 | 0 / 118 |
Outcome results
Primary
Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value
Anti-HAV antibody concentration cut-off value assessed was ≥ 15 milli-International Units per milliliter (mIU/mL).
Time frame: Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination
Population: Analysis was performed on the Long Term According To Protocol (ATP) cohort for immunogenicity, which included all subjects for whom serology results were available for a particular blood sampling visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group Twinrix Junior | Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value | Year 7 (n= 105, 92) | 105 subjects |
| Group Twinrix Junior | Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value | Year 9 (n= 103, 90) | 103 subjects |
| Group Twinrix Junior | Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value | Year 8 (n= 104, 93) | 104 subjects |
| Group Twinrix Junior | Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value | Year 10 (n= 100, 77) | 100 subjects |
| Group Twinrix Junior | Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value | Year 6 (n=113, 100) | 113 subjects |
| Group Twinrix Adult | Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value | Year 10 (n= 100, 77) | 77 subjects |
| Group Twinrix Adult | Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value | Year 6 (n=113, 100) | 100 subjects |
| Group Twinrix Adult | Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value | Year 7 (n= 105, 92) | 92 subjects |
| Group Twinrix Adult | Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value | Year 8 (n= 104, 93) | 93 subjects |
| Group Twinrix Adult | Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value | Year 9 (n= 103, 90) | 90 subjects |
Primary
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value
Anti-HBs antibody concentration cut-off value assessed was ≥ 3.3 mIU/mL.
Time frame: Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination
Population: Analysis was performed on the ATP cohort for immunogenicity, which included all subjects for whom serology results were available for a particular blood sampling visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group Twinrix Junior | Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value | Year 7 (n= 105, 92) | 98 subjects |
| Group Twinrix Junior | Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value | Year 9 (n= 103, 90) | 96 subjects |
| Group Twinrix Junior | Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value | Year 8 (n= 104, 93) | 96 subjects |
| Group Twinrix Junior | Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value | Year 10 (n= 101, 78) | 97 subjects |
| Group Twinrix Junior | Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value | Year 6 (n= 113, 100) | 100 subjects |
| Group Twinrix Adult | Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value | Year 10 (n= 101, 78) | 75 subjects |
| Group Twinrix Adult | Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value | Year 6 (n= 113, 100) | 93 subjects |
| Group Twinrix Adult | Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value | Year 7 (n= 105, 92) | 85 subjects |
| Group Twinrix Adult | Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value | Year 8 (n= 104, 93) | 84 subjects |
| Group Twinrix Adult | Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value | Year 9 (n= 103, 90) | 86 subjects |
Primary
Serious Adverse Events (SAE) Causally Related to Primary Vaccination or Related to Hepatitis A or B Infection or Related to Study Participation (Blood Sampling)
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time frame: From Year 6 through to Year 10
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group Twinrix Junior | Serious Adverse Events (SAE) Causally Related to Primary Vaccination or Related to Hepatitis A or B Infection or Related to Study Participation (Blood Sampling) | 0 subjects |
| Group Twinrix Adult | Serious Adverse Events (SAE) Causally Related to Primary Vaccination or Related to Hepatitis A or B Infection or Related to Study Participation (Blood Sampling) | 0 subjects |