| ID | Type | Description | Link |
|---|---|---|---|
| 101696 | Other Identifier | GSK | |
| 101697 | Other Identifier | GSK | |
| 101698 | Other Identifier | GSK | |
| 2015-001531-20 | EudraCT Number |
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To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months after the first dose of the hepatitis B primary vaccination course.
Subjects were aged 11 to 15 years at the time of the primary vaccination course.
At the time of enrollment in the present long-term follow-up study subjects were aged 13 to 18 years.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
All subjects who participated in the primary study, in which they received either 2 or 3 doses of GSK Biologicals hepatitis B vaccine, and who consented to participate in the long-term follow-up at Month 42 were contacted by the investigators.
No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2-Dose Engerix | Experimental | subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month. |
|
| 3-Dose Engerix | Active Comparator | subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engerix™-B (thiomersal-free) 20µg | Biological | In the primary study: 2 deep intramuscular injections (Months 0, & 6) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody. | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. | At Month 7 |
| Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody. | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. | At Month 30, Month 42, Month 54 and Month 66 |
| Antibody Titers Against Hepatitis-B Virus. | Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs. | At Month 30, Month 42, Month 54 and Month 66 |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Titers Against Hepatitis-B Virus. | Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs. | At Months 1, 2, 6 and 7 |
| Number of Subjects Seroprotected for Anti-HBs Antibody. |
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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 | Sydney | New South Wales | Australia | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17276552 | Background | Heron L, Selnikova O, Moiseieva A, Van Damme P, van der Wielen M, Levie K, Hoet B, Stoffel M. Immunogenicity, reactogenicity and safety of two-dose versus three-dose (standard care) hepatitis B immunisation of healthy adolescents aged 11-15 years: a randomised controlled trial. Vaccine. 2007 Apr 12;25(15):2817-22. doi: 10.1016/j.vaccine.2006.12.021. Epub 2006 Dec 29. | |
| 12297392 |
| 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 |
|---|---|---|---|
| 101695 Ext. Mth30 | Informed Consent Form | 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.
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All subjects who participated in the primary vaccination study, in which they received either 2 or 3 doses of GSK Biologicals hepatitis B vaccine, and who consented to participate in the long-term follow-up were contacted by the investigators. No additional subjects were recruited during this long-term follow-up study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 2-dose Engerix | subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month. |
| FG001 | 3-dose Engerix |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Primary Study |
|
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| 10 μg Engerix™-B (preservative-free) | Biological | In the primary study: 3 deep intramuscular injections (months 0, 1 & 6) |
|
| placebo | Biological | In the primary study: 1 deep intramuscular injection (month 1) |
|
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
| At Months 1, 2 and 6 |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. | During the 4-day (Day 0-3) follow-up period after each vaccination and overall |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, and fever. Any was defined as incidence of the specified symptoms regardless of intensity or relationship to study vaccine. Gastrointestinal symptoms included nausea, vomiting, diarrhea and abdominal pain. Grade 3 fever was defined as fever (axillary temperature) > 38.5°C. Grade 3 symptoms were defined as symptoms which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination. | During the 4-day (Day 0-3) follow-up period after each vaccination and overall |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE). | An unsolicited AE covers 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 31-day (Day 0-30) follow-up period after each vaccination and overall |
| Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. | During the entire study period (Month 0 to Month 66) |
| Number of Subjects With Serious Adverse Events (SAEs). | erious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. | At Month 30, Month 42, Month 54 & Month 66 |
| Brussels |
| 1200 |
| Belgium |
| GSK Investigational Site | Wilrijk | 2610 | Belgium |
| GSK Investigational Site | Kyiv | 03038 | Ukraine |
| Background |
| Heron LG, Chant KG, Jalaludin BB. A novel hepatitis B vaccination regimen for adolescents: two doses 12 months apart. Vaccine. 2002 Oct 4;20(29-30):3472-6. doi: 10.1016/s0264-410x(02)00346-8. |
| 21171982 | Background | Van Damme P, Moiseeva A, Marichev I, Kervyn AD, Booy R, Kuriyakose S, Brockway A, Ng SP, Leyssen M, Jacquet JM. Five years follow-up following two or three doses of a hepatitis B vaccine in adolescents aged 11-15 years: a randomised controlled study. BMC Infect Dis. 2010 Dec 20;10:357. doi: 10.1186/1471-2334-10-357. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 101695 Ext. Mth30 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 101695 Ext. Mth30 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 101695 Ext. Mth30 | 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 101695 (Ext HBV-280 M30) are summarised with studies 103860/280 (HBV-280), 101696 (Ext HBV-280 M42), 101697 (Ext HBV-280 M54) and 101698 |
| 101695 Ext. Mth30 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
| COMPLETED |
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| NOT COMPLETED |
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| Month 30 Follow-up |
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| Month 42 Follow-up |
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| Month 54 Follow-up |
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| Month 66 Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | 2-dose Engerix | subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month. |
| BG001 | 3-dose Engerix | subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively. |
| 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 |
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| 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 | Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody. | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. | The ATP cohort for immunogenicity included all evaluable subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw. | Posted | Number | Subjects | At Month 7 |
|
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| |||||||||||||||||||||||||||||
| Primary | Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody. | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. | Long Term According-to-Protocol cohort for immunogenicity, including all subjects who returned at the considered follow-up time point and who complied with the protocol. | Posted | Number | Subjects | At Month 30, Month 42, Month 54 and Month 66 |
|
| ||||||||||||||||||||||||||||||
| Primary | Antibody Titers Against Hepatitis-B Virus. | Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs. | Long Term According-to-Protocol cohort for immunogenicity, including all subjects who returned at the considered follow-up time point and who complied with the protocol. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Month 30, Month 42, Month 54 and Month 66 |
|
| |||||||||||||||||||||||||||||
| Secondary | Antibody Titers Against Hepatitis-B Virus. | Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs. | The ATP cohort for immunogenicity included all evaluable subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Months 1, 2, 6 and 7 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Subjects Seroprotected for Anti-HBs Antibody. | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. | The ATP cohort for immunogenicity included all evaluable subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw. | Posted | Number | Subjects | At Months 1, 2 and 6 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. | The ATP cohort for safety included all evaluable subjects, who received at least one dose of study vaccine according to their random assignment, with sufficient data to perform safety analysis, who did not receive a vaccine not specified or forbidden in the protocol. | Posted | Number | Subjects | During the 4-day (Day 0-3) follow-up period after each vaccination and overall |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, and fever. Any was defined as incidence of the specified symptoms regardless of intensity or relationship to study vaccine. Gastrointestinal symptoms included nausea, vomiting, diarrhea and abdominal pain. Grade 3 fever was defined as fever (axillary temperature) > 38.5°C. Grade 3 symptoms were defined as symptoms which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination. | The ATP cohort for safety included all evaluable subjects, who received at least one dose of study vaccine according to their random assignment, with sufficient data to perform safety analysis, who did not receive a vaccine not specified or forbidden in the protocol. | Posted | Number | Subjects | During the 4-day (Day 0-3) follow-up period after each vaccination and overall |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE). | An unsolicited AE covers 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. | Total Cohort included all enrolled (i.e. randomized or vaccinated) subjects who received at least one vaccine dose and for whom data were available. No information regarding AEs was available for 1 subject in each group | Posted | Number | Subjects | During the 31-day (Day 0-30) follow-up period after each vaccination and overall |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. | Total Cohort included all enrolled (i.e. randomized or vaccinated) subjects who received at least one vaccine dose and for whom data were available. No information regarding AEs was available for 1 subject in each group. | Posted | Number | Subjects | During the entire study period (Month 0 to Month 66) |
|
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs). | erious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. | LT total cohort included all subjects who were included in the total cohort in the primary study and returned at the considered follow-up time point. | Posted | Number | Participants | At Month 30, Month 42, Month 54 & Month 66 |
|
|
Serious adverse events: during the entire study period (Month 0-66), Solicited local and general symptoms: During the 4-day (Days 0-3) post vaccination period and unsolicited adverse events: up to Month 7.Non-serious adverse events were not assessed during the long term follow-up period (Month 30-66). The total number of participants at risk is the number of participants with at least one documented dose.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
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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 | 2-dose Engerix | subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month. | 0 | 257 | 4 | 257 | 155 | 257 |
| EG001 | 3-dose Engerix | subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively. | 0 | 125 | 1 | 125 | 74 | 125 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injury | Injury, poisoning and procedural complications | WHO | Non-systematic Assessment |
| |
| Arthritis | Infections and infestations | WHO | Non-systematic Assessment |
| |
| Ileitis | Gastrointestinal disorders | WHO | Non-systematic Assessment |
| |
| Infection bacterial | Infections and infestations | WHO | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain; Dose 1 | General disorders | WHO | Systematic Assessment |
| |
| Redness; Dose 1 | General disorders | WHO | Systematic Assessment |
| |
| Swelling; Dose 1 | General disorders | WHO | Systematic Assessment |
| |
| Pain; Dose 2 | General disorders | WHO | Systematic Assessment |
| |
| Redness; Dose 2 | General disorders | WHO | Systematic Assessment |
| |
| Pain; Dose 3 | General disorders | WHO | Systematic Assessment |
| |
| Redness; Dose 3 | General disorders | WHO | Systematic Assessment |
| |
| Swelling; Dose 3 | General disorders | WHO | Systematic Assessment |
| |
| Pain; Across Doses | General disorders | WHO | Systematic Assessment |
| |
| Redness; Across Doses | General disorders | WHO | Systematic Assessment |
| |
| Swelling; Across Doses | General disorders | WHO | Systematic Assessment |
| |
| Fatigue; Dose 1 | General disorders | WHO | Systematic Assessment |
| |
| Gastrointestinal symptoms; Dose 1 | Gastrointestinal disorders | WHO | Systematic Assessment |
| |
| Headache; Dose 1 | Nervous system disorders | WHO | Systematic Assessment |
| |
| Fatigue; Dose 2 | General disorders | WHO | Systematic Assessment |
| |
| Gastrointestinal symptoms; Dose 2 | Gastrointestinal disorders | WHO | Systematic Assessment |
| |
| Headache; Dose 2 | Nervous system disorders | WHO | Systematic Assessment |
| |
| Fatigue; Dose 3 | General disorders | WHO | Systematic Assessment |
| |
| Gastrointestinal symptoms; Dose 3 | Gastrointestinal disorders | WHO | Systematic Assessment |
| |
| Fever; Dose 3 | General disorders | WHO | Systematic Assessment |
| |
| Fatigue; Across Doses | General disorders | WHO | Systematic Assessment |
| |
| Gastrointestinal symptoms; Across Doses | Gastrointestinal disorders | WHO | Systematic Assessment |
| |
| Headache; Across Doses | Nervous system disorders | WHO | Systematic Assessment |
| |
| Fever; Across Doses | General disorders | WHO | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | WHO | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | WHO | Non-systematic Assessment |
| |
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | WHO | Non-systematic Assessment |
| |
| Headache; Dose 3 | Nervous system disorders | WHO | 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 centres of a multi-centre 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 |
| 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 |
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| Male |
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| Units | Counts |
|---|---|
| Participants |
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