| ID | Type | Description | Link |
|---|---|---|---|
| 208127/133 (EXT Y3) | Other Identifier | GSK | |
| 208127/134 (EXT Y4) | Other Identifier | GSK | |
| 208127/137 (EXT Y5) | Other Identifier | GSK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of the study vaccine.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Open, randomised, self-contained, multicentric, multinational, long-term antibody persistence studies. Immune persistence was compared between subjects who received either two dose or three doses of GSK Biologicals combined hepatitis A and hepatitis B vaccine. The long-term follow-up studies involved taking blood samples at approximately 2, 3, 4 and 5 years after the primary vaccination of combined hepatitis A and B vaccine to assess antibody persistence. No additional subjects will be recruited during the long term follow-up period.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Twinrix Junior | Experimental | Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation). |
|
| Twinrix Adult | Active Comparator | Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Twinrix™ Adult | Biological | Intramuscular injection in the left deltoid, 2 doses, Adult formulation in primary study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-hepatitis A (HAV) Antibody Concentrations | Geometric mean concentration for anti-HAV antibodies expressed as Milli-International Units per milliliter (mIU/mL) | Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60) |
| Anti-hepatitis B (HBs) Antibody Concentrations | Geometric mean concentration for anti-HBs antibodies expressed as Milli-International Units per milliliter (mIU/mL). | Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60) |
| Anti-HAV Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose. | Any subjects becoming seronegative for anti-HAV antibodies (i.e. titres < 15 mIU/ml) at any long term time point, were to receive an additional vaccine dose administered between 6 to 12 months after Year 5 time point. | Before and one month after additional vaccination |
| Anti-HBs Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose. | Subjects losing seroprotective anti-HBs antibody titres (i.e. titres < 10 mIU/ml) at any long term time point, received an Engerix challenge dose. The table presents the geometric mean concentrations for anti-HBs antibodies, expressed as Milli-International Units per milliliter (mIU/mL). | Before and One month after additional vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Serious Adverse Events (SAEs) Determined by the Investigator to Have a Causal Relationship to Primary Vaccination or Due to Lack of Vaccine Efficacy. | A serious adverse event (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. |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | North Adelaide | South Australia | 5006 | Australia | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20434544 | Background | Marshall H, Nolan T, Diez Domingo J, Rombo L, Sokal EM, Mares J, Casanovas JM, Kuriyakose S, Leyssen M, Jacquet JM. Long-term (5-year) antibody persistence following two- and three-dose regimens of a combined hepatitis A and B vaccine in children aged 1-11 years. Vaccine. 2010 Jun 17;28(27):4411-5. doi: 10.1016/j.vaccine.2010.04.040. Epub 2010 Apr 29. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 208127/132 (EXT Y2) | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Twinrix Adult | Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation). |
| FG001 | Twinrix Junior | Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Twinrix™ Junior | Biological | Intramuscular injection in the left deltoid, 3 doses, junior formulation in primary study. |
|
|
| From last study visit of the primary study up to Year 5 long term follow-up |
| Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling at the vaccine injection site. Any= regardless of intensity grade; Grade 3 Pain= spontaneously painful | during the 4-day follow-up period after additional vaccination |
| Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited General Symptoms. | Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache. Any= regardless of intensity grade or relationship to vaccination; grade 3= prevented normal activity; Related= considered by the investigator to be causally related to the vaccination | During the 4-day follow-up period after additional vaccination |
| Number of Subjects Receiving an Additional Vaccine Dose and Reporting Unsolicited Adverse Events (AEs). | An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | During the 30-day follow-up period after additional vaccination. |
| Number of Subjects Receiving an Additional Vaccine Dose and Reporting Any Serious Adverse Events | A serious adverse event (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. | At least one month after additional vaccination |
| Carlton |
| Victoria |
| 3053 |
| Australia |
| GSK Investigational Site | Brussels | 1200 | Belgium |
| GSK Investigational Site | Barcelona | 08042 | Spain |
| GSK Investigational Site | Blanes (Girona) | 17300 | Spain |
| GSK Investigational Site | Cerdanyola Del Vallés / Barcelona | 08290 | Spain |
| GSK Investigational Site | Valencia | 46024 | Spain |
For additional information about this study please refer to the GSK Clinical Study Register |
| 208127/132 (EXT Y2) | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 208127/132 (EXT Y2) | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 208127/132 (EXT Y2) | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 208127/132 (EXT Y2) | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 208127/132 (EXT Y2) | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 208127/132 are summarised with studies 208122/133, 208127/134 and 208127/137 on the GSK Clinical Study Register. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Twinrix Adult | Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation). |
| BG001 | Twinrix Junior | Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 (HAV) Antibody Concentrations | Geometric mean concentration for anti-HAV antibodies expressed as Milli-International Units per milliliter (mIU/mL) | Analysis was performed on the Long Term According to Protocol cohort for analysis of immunogenicity (LT ATP immunogenicity cohort) which included all subjects that complied with the protocol and for whom data concerning immunogenicity endpoint measures were available for the particular time point measured. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60) |
|
|
| ||||||||||||||||||||||||||||
| Primary | Anti-hepatitis B (HBs) Antibody Concentrations | Geometric mean concentration for anti-HBs antibodies expressed as Milli-International Units per milliliter (mIU/mL). | Analysis was performed on the Long Term According to Protocol cohort for analysis of immunogenicity (LT ATP immunogenicity cohort) which included all subjects that complied with the protocol and for whom data concerning immunogenicity endpoint measures were available for the particular time point measured. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60) |
|
| |||||||||||||||||||||||||||||
| Primary | Anti-HAV Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose. | Any subjects becoming seronegative for anti-HAV antibodies (i.e. titres < 15 mIU/ml) at any long term time point, were to receive an additional vaccine dose administered between 6 to 12 months after Year 5 time point. | None of the subjects became seronegative for anti-HAV antibodies during the Year 2 to Year 5 long term follow-up. Hence none of the subjects received an additional Havrix dose. | Posted | Before and one month after additional vaccination |
|
| ||||||||||||||||||||||||||||||||
| Primary | Anti-HBs Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose. | Subjects losing seroprotective anti-HBs antibody titres (i.e. titres < 10 mIU/ml) at any long term time point, received an Engerix challenge dose. The table presents the geometric mean concentrations for anti-HBs antibodies, expressed as Milli-International Units per milliliter (mIU/mL). | Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Before and One month after additional vaccination |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) Determined by the Investigator to Have a Causal Relationship to Primary Vaccination or Due to Lack of Vaccine Efficacy. | A serious adverse event (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. | The analysis was performed on the Long term Total vaccinated cohort wich included all subjects who returned at a specified follow-up study | Posted | Count of Participants | Participants | From last study visit of the primary study up to Year 5 long term follow-up |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling at the vaccine injection site. Any= regardless of intensity grade; Grade 3 Pain= spontaneously painful | Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5. | Posted | Count of Participants | Participants | during the 4-day follow-up period after additional vaccination |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited General Symptoms. | Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache. Any= regardless of intensity grade or relationship to vaccination; grade 3= prevented normal activity; Related= considered by the investigator to be causally related to the vaccination | Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5. | Posted | Count of Participants | Participants | During the 4-day follow-up period after additional vaccination |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Receiving an Additional Vaccine Dose and Reporting Unsolicited Adverse Events (AEs). | An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5. | Posted | Count of Participants | Participants | During the 30-day follow-up period after additional vaccination. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Receiving an Additional Vaccine Dose and Reporting Any Serious Adverse Events | A serious adverse event (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. | Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5. | Posted | Count of Participants | Participants | At least one month after additional vaccination |
|
|
Solicited symtoms: During the 4-day (Day 0-3) follow-up period after the additional vaccination. Unsolicited AEs: During the 31-day (Day 0-30) period after the additional vaccination; SAEs: During the entire study period
Solicited and unsolicited symptoms were collected on the Total vaccinated cohort for the challenge dose for subjects who received the additional vaccine dose after the Year 5; SAEs were collected on the Long term Total vaccinated cohort throughout the study period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Twinrix Adult | Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation). | 0 | 139 | 7 | 11 | ||
| EG001 | Twinrix Junior | Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation). | 0 | 137 | 0 | 5 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Syncope vasovagal | Nervous system disorders | Non-systematic Assessment |
| ||
| Balanitis | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Redness at the injection site | General disorders | Systematic Assessment |
| ||
| Pain at the injection site | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Gastrointestinal disorder | General disorders | Systematic Assessment |
| ||
| Headache | General disorders | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D006506 | Hepatitis A |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| 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 |
Not provided
Not provided
| Male |
|
| At year 3 |
|
|
| At year 4 |
|
|
| At year 5 |
|
|
|
|
|
|
|
|
|
|