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| ID | Type | Description | Link |
|---|---|---|---|
| 100562 (Year 7) | Other Identifier | GSK | |
| 100563 (Year 8) | Other Identifier | GSK | |
| 100564 (Year 9) | Other Identifier | GSK | |
| 100565 (Year 10) | Other Identifier | GSK |
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The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 6, 7, 8, 9 and 10 after subjects received their first two doses primary vaccination schedule of combined hepatitis A/hepatitis B vaccine.
This protocol posting deals with objectives & outcome measures of the extension phase at year 6 through to 10.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
To evaluate the long-term antibody persistence, volunteers will be bled at Years 6, 7, 8, 9 and 10 after the first vaccine dose of the primary vaccination course to determine their anti-HAV and anti-HBs antibody concentrations.
If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Twinrix Group | Experimental | Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix in the primary study (208127/076) |
|
| Engerix-B Additional Dose (Adult) | Experimental | Subjects aged 16 years and above who received an additional dose of EngerixTM-B (adult dose). |
|
| Engerix-B Additional Dose (Pediatric) | Experimental | Subjects under the age of 16 years who received an additional dose of EngerixTM-B (pediatric dose). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TWINRIX™ ADULT | Biological | 2 doses IM injection in primary study |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration | Years 6, 7, 8, 9, and 10. | |
| Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration | At Year 6, 7, 8, 9 and 10 | |
| Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration | Before and 1 month after the additional dose administration | |
| Number of Subjects With Immune Response to the Additional Dose of Engerix™-B | Immune response was defined as:
| One month after the additional dose administration |
| Number of Subjects Reporting Serious Adverse Events (SAEs) Assessed by the Investigator as Causally Related to Primary Vaccination, Study Procedures or Lack of Vaccine Efficacy | Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | At Year 6, 7, 8, 9 and 10 |
| Number of Subjects Reporting Solicited Local and General Symptoms | Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache. | During the 4-day follow-up period after additional dose |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Wilrijk | 2610 | Belgium |
25 subjects lost seroprotective concentrations for anti-HBs antibodies at blood sampling time-points Years 6 to 10 and were offered an additional dose of Engerix™-B after Year 10 (additional dose phase). These subjects are presented in separate sub-groups for analysis purposes while as per study protocol, the single experimental group is Twinrix.
All subjects enrolled in the primary study (208127/076) were invited to come back for the long-term follow-up visits at Year 6 to 10. The enrollment in the protocol section reflects the amount of subjects who came back at year 6. At follow up timepoints less subjects came back.
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| ID | Title | Description |
|---|---|---|
| FG000 | Twinrix Group | Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076) |
| FG001 | Engerix-B Additional Dose (Adult) | Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose). |
| FG002 | Engerix-B Additional Dose (Pediatric) | Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Year 6 Long-term Follow-up |
| |||||||||||||
| Year 7 Long-term Follow-up |
| |||||||||||||
| Year 8 Long-term Follow-up |
| |||||||||||||
| Year 9 Long-term Follow-up |
| |||||||||||||
| Year 10 Long-term Follow-up |
| |||||||||||||
| Additional Dose Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Twinrix Group | Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration | The analysis was performed on the long-term (LT) according to protocol (ATP) cohort for immunogenicity. | Posted | Geometric Mean | 95% Confidence Interval | milli-international units per milliliter | Years 6, 7, 8, 9, and 10. |
|
|
SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Engerix-B Additional Dose (Adult) | Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D006506 | Hepatitis A |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| Engerix TM |
| Biological |
If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose. |
|
| Number of Subjects Reporting Unsolicited Adverse Events | Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | During the 30-day follow-up period after additional dose |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | During the 30-day follow-up period after additional dose |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration | The analysis was performed on the long-term (LT) according to protocol (ATP) cohort for immunogenicity. | Posted | Geometric Mean | 95% Confidence Interval | milli-international units per milliliter | At Year 6, 7, 8, 9 and 10 |
|
|
|
| Primary | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration | The analysis was performed on the total vaccinated cohort for the additional dose. | Posted | Geometric Mean | 95% Confidence Interval | milli-international units per milliliter | Before and 1 month after the additional dose administration |
|
|
|
| Primary | Number of Subjects With Immune Response to the Additional Dose of Engerix™-B | Immune response was defined as:
| The analysis was performed on the total vaccinated cohort for the additional dose. | Posted | Count of Participants | Participants | One month after the additional dose administration |
|
|
|
| Primary | Number of Subjects Reporting Serious Adverse Events (SAEs) Assessed by the Investigator as Causally Related to Primary Vaccination, Study Procedures or Lack of Vaccine Efficacy | Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | The analysis was performed on the long-term (LT) total vaccinated cohort. | Posted | Count of Participants | Participants | At Year 6, 7, 8, 9 and 10 |
|
|
|
| Primary | Number of Subjects Reporting Solicited Local and General Symptoms | Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache. | The analysis was performed on the total vaccinated cohort for the additional dose. | Posted | Count of Participants | Participants | During the 4-day follow-up period after additional dose |
|
|
|
| Primary | Number of Subjects Reporting Unsolicited Adverse Events | Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | The analysis was performed on the total vaccinated cohort for the additional dose. | Posted | Count of Participants | Participants | During the 30-day follow-up period after additional dose |
|
|
|
| Primary | Number of Subjects Reporting Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | The analysis was performed on the total vaccinated cohort for the additional dose. | Posted | Count of Participants | Participants | During the 30-day follow-up period after additional dose |
|
|
|
| 0 |
| 19 |
| 8 |
| 19 |
| EG001 | Twinrix Group | Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076) | 0 | 0 | 0 | 0 |
| EG002 | Engerix-B Additional Dose (Pediatric) | Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose). | 0 | 6 | 3 | 6 |
| Redness | General disorders | Systematic Assessment |
|
| Swelling | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Gastrointestinal symptoms | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
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.
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| Title | Measurements |
|---|---|
|
| Year 8 (n= 132) |
|
|
| Year 9 (n = 121) |
|
|
| Year 10 (n= 120) |
|
|
|
| Year 8 (n= 174) |
|
|
| Year 9 (n= 173) |
|
|
| Year 10 (n= 171) |
|
|
| Swelling |
|
| Fatigue |
|
| Fever |
|
| Gastrointestinal symptoms |
|
| Headache |
|