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This study is performed to evaluate the persistence of anti-hepatitis B surface antigen (HBs) antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine, Engerix-Bâ„¢. No new subjects will be recruited in this long-term follow-up study.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
The primary study was to evaluate the immunogenicity and protective efficacy of hepatitis B vaccine administered according to a 0, 1, 2, 12 month schedule in newborns of anti-hepatitis B envelope antigen positive (HBeAg+) and anti-hepatitis B surface antigen positive (HBsAg+) mothers. Results from the primary study have shown that the vaccine was immunogenic and protected neonates of HBeAg positive mothers against hepatitis B chronic carriage. The present study is carried out to evaluate the anti-HBs persistence and the prevalence and incidence of other hepatitis B markers (HBsAg, anti-hepatitis B core antigen {anti-HBc}, HBeAg, Alanine aminotransferase/Aspartate aminotransferase {ALT/AST}), and the clinical significance of the HBsAg and anti-HBc positive cases observed during the long-term from year 16-20. No vaccine will be administered during the long term follow up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBsAg(+) & HBeAg(-) 4-dose Group | Experimental | Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen negative [HBeAg(-)] mothers, who received 4 doses of Engerixâ„¢ in the primary study. |
|
| HBsAg(+) & HBeAg(+) 4-dose Group | Experimental | Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 4 doses of Engerixâ„¢ in the primary study. |
|
| HBsAg(+) & HBeAg(+) 5-dose Group | Experimental | Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerixâ„¢ in the primary study. |
|
| HBsAg(-) & HBeAg(-) 4-dose Group | Experimental | Newborns of anti-hepatitis B surface antigen negative [HBsAg(-)] and hepatitis B envelope antigen negative [HBeAg(-)] mothers, who received 4 doses of Engerixâ„¢ in the primary study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Procedure | A blood sample will be taken yearly at each long-term follow-up time point (i.e. Year 16 through Year 20) after the first dose of Engerix-Bâ„¢ vaccine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies | Seropositive subjects are subjects with anti-HBs antibody concentration ≥ 3.3 mIU/mL. | At Years 16, 17, 18, 19 and 20 after primary vaccination |
| Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | Tested markers were hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen (anti-HBc), hepatitis B envelope antigen (HBeAg) and antibody to hepatitis B envelope antigen (anti-HBe). | At Years 16, 17, 18,19 and 20 after primary vaccination |
| Number of Subjects With Chronic and With Clinical HBV Infection |
| From year 16 through to year 20 |
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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 | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19473096 | Background | Poovorawan Y, Chongsrisawat V, Theamboonlers A, Srinivasa K, Hutagalung Y, Bock HL, Hoet B. Long-term benefit of hepatitis B vaccination among children in Thailand with transient hepatitis B virus infection who were born to hepatitis B surface antigen-positive mothers. J Infect Dis. 2009 Jul 1;200(1):33-8. doi: 10.1086/599331. | |
| Background | Poovorawan Y et al. Persistence of anti-HBs antibodies and immune memory 20-years after hepatitis B vaccination among children in Thailand. Abstract presented at the 9th International Congress of Tropical Pediatrics (ICTP). Bangkok, Thailand. 18-20 October 2011. | ||
| 23732904 |
| 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 |
|---|---|---|---|
| 100449 | Individual Participant Data Set | 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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Participant Flow and Baseline measures are given for the year 20 time point in order to account for all subjects participating in this long-term follow-up study.
Note that not all subjects returned and participated in each of the intermediate follow-up time points.
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| ID | Title | Description |
|---|---|---|
| FG000 | HBsAg(+) & HBeAg(+) 5-dose Group | Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerixâ„¢ in the primary study. |
| FG001 | HBsAg(+) & HBeAg(-) 4-dose Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Derived |
| Poovorawan Y, Chongsrisawat V, Theamboonlers A, Crasta PD, Messier M, Hardt K. Long-term anti-HBs antibody persistence following infant vaccination against hepatitis B and evaluation of anamnestic response: a 20-year follow-up study in Thailand. Hum Vaccin Immunother. 2013 Aug;9(8):1679-84. doi: 10.4161/hv.24844. Epub 2013 May 31. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 100449 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100449 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100449 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100449 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerixâ„¢ in the primary study. |
| FG002 | HBsAg(+) & HBeAg(+) 4-dose Group | Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerixâ„¢ in the primary study. |
| FG003 | HBsAg(-) & HBeAg(-) 4-dose Group | Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerixâ„¢ in the primary study. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | HBsAg(+) & HBeAg(+) 5-dose Group | Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerixâ„¢ in the primary study. |
| BG001 | HBsAg(+) & HBeAg(-) 4-dose Group | Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerixâ„¢ in the primary study. |
| BG002 | HBsAg(+) & HBeAg(+) 4-dose Group | Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerixâ„¢ in the primary study. |
| BG003 | HBsAg(-) & HBeAg(-) 4-dose Group | Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerixâ„¢ in the primary study. |
| BG004 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Gender | 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 Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies | Seropositive subjects are subjects with anti-HBs antibody concentration ≥ 3.3 mIU/mL. | The analyses were performed on the Long-Term According to protocol (ATP) cohort for immunogenicity. Due to subjects being lost to follow up or eliminated from the ATP cohort for immunogenicity, no data from subjects in HBsAg(+) & HBeAg(-) 4-dose Group and HBsAg(-) & HBeAg(-) 4-dose Group were analyzed. | Posted | Number | subjects | At Years 16, 17, 18, 19 and 20 after primary vaccination |
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| Primary | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | Tested markers were hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen (anti-HBc), hepatitis B envelope antigen (HBeAg) and antibody to hepatitis B envelope antigen (anti-HBe). | The analyses were performed on the ATP cohort for immunogenicity. Only subjects positive for HBsAg or anti-HBc markers were tested for HBeAg and anti-HBe markers for Year 17 to Year 20. | Posted | Number | subjects | At Years 16, 17, 18,19 and 20 after primary vaccination |
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Chronic and With Clinical HBV Infection |
| Posted | Number | subjects | From year 16 through to year 20 |
|
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No Adverse Event information was collected during this study
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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 | HBsAg(+) & HBeAg(+) 5-dose Group | Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerixâ„¢ in the primary study. | 0 | 0 | 0 | 0 | ||
| EG001 | HBsAg(+) & HBeAg(-) 4-dose Group | Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerixâ„¢ in the primary study. | 0 | 0 | 0 | 0 | ||
| EG002 | HBsAg(+) & HBeAg(+) 4-dose Group | Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerixâ„¢ in the primary study. | 0 | 0 | 0 | 0 | ||
| EG003 | HBsAg(-) & HBeAg(-) 4-dose Group | Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerixâ„¢ in the primary study. | 0 | 0 | 0 | 0 |
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No safety data were collected during this long-term follow-up study.
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 |
| 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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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Year 18 (n= 1, 22) |
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| Year 19 (n= 2, 22) |
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| Year 20 (n= 2, 25) |
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| OG003 |
| HBsAg(-) & HBeAg(-) 4-dose Group |
Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerixâ„¢ in the primary study. |
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