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The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen (anti-HBs) antibodies 16, 17, 18, 19 and 20 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.
The primary study was designed to evaluate the immunogenicity and protective efficacy of hepatitis B vaccine in newborns of HBeAg+ and HBsAg+ mothers in comparison with a historical control group.
The present study is carried out to evaluate the anti-HBs persistence 16-20 years after the first vaccine dose and to further investigate the prevalence and incidence of other hepatitis B markers and the clinical significance of these at all time points from Year 16-20.
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 |
|---|---|---|---|
| HBV-1 Group | Experimental | neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60) |
|
| HBV-2 Group | Experimental | neonates born to HBsAg+ and HBeAg+ mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12) |
|
| HBV-3 Group | Experimental | neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60) |
|
| HBV-4 Group | Experimental | neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12) |
|
| HBV-5 Group | Experimental | neonates born to HBsAg- and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engerixâ„¢-B | Biological | In the primary study, subjects received HBV (10 milligram) vaccine according to a 0, 1 and 2 month schedule with a booster dose at Month 12. Subjects in the 5-dose vaccination regimen received a booster dose of HBV vaccine at Month 60. |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations | During this follow-up study, it was planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Therefore, the table presents mean concentrations expressed in milli-international units/milliliter (mIU/mL) at years 17, 18, 19 and 20. | Years 17, 18, 19 and 20. |
| Prevalence of Serological Markers for Hepatitis B Infection | It was initially planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Only the subjects positive for HBsAg or anti Hepatitis B core antigen (anti-HBc) were tested for HBeAg & anti-HBe | Years 17, 18, 19 and 20. |
| Clinical Review for Hepatitis B Infection Status | Chronic hepatitis B (HB) carrier is defined as positive for anti-HBc AND HBsAg at two or more consecutive time points | Over the entire 4 year follow up period (17 - 20 years) |
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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 |
|---|---|---|---|
| 20384962 | Derived | Poovorawan Y, Chongsrisawat V, Theamboonlers A, Leroux-Roels G, Kuriyakose S, Leyssen M, Jacquet JM. Evidence of protection against clinical and chronic hepatitis B infection 20 years after infant vaccination in a high endemicity region. J Viral Hepat. 2011 May;18(5):369-75. doi: 10.1111/j.1365-2893.2010.01312.x. | |
| 19892043 | Derived |
| 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 |
|---|---|---|---|
| 100448 | Clinical Study Report | 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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| ID | Title | Description |
|---|---|---|
| FG000 | HBV 5 Group | neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60) |
| FG001 | HBV 2 Group | neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12) |
| FG002 | HBV 1 Group | neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60) |
| FG003 | HBV 4 Group | neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12) |
| FG004 | HBV 3 Group | neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60) |
| FG005 | HBV 6 Group | neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HBV 5 Group | neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60) |
| BG001 | HBV 2 Group |
| 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 B Surface Antigen (Anti-HBs) Antibody Concentrations | During this follow-up study, it was planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Therefore, the table presents mean concentrations expressed in milli-international units/milliliter (mIU/mL) at years 17, 18, 19 and 20. | Posted | Mean | 95% Confidence Interval | mIU/mL | Years 17, 18, 19 and 20. |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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|
| HBV-6 Group | Experimental | neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12) |
|
| Poovorawan Y, Chongsrisawat V, Theamboonlers A, Bock HL, Leyssen M, Jacquet JM. Persistence of antibodies and immune memory to hepatitis B vaccine 20 years after infant vaccination in Thailand. Vaccine. 2010 Jan 8;28(3):730-6. doi: 10.1016/j.vaccine.2009.10.074. Epub 2009 Nov 3. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 100448 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100448 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100448 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100448 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12) |
| BG002 | HBV 1 Group | neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60) |
| BG003 | HBV 4 Group | neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12) |
| BG004 | HBV 3 Group | neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60) |
| BG005 | HBV 6 Group | neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12) |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12) |
| OG002 | HBV 1 Group | neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60) |
| OG003 | HBV 4 Group | neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12) |
| OG004 | HBV 3 Group | neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60) |
| OG005 | HBV 6 Group | neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12) |
|
|
| Primary | Prevalence of Serological Markers for Hepatitis B Infection | It was initially planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Only the subjects positive for HBsAg or anti Hepatitis B core antigen (anti-HBc) were tested for HBeAg & anti-HBe | Posted | Number | Percentage of participants (%) | Years 17, 18, 19 and 20. |
|
|
|
| Primary | Clinical Review for Hepatitis B Infection Status | Chronic hepatitis B (HB) carrier is defined as positive for anti-HBc AND HBsAg at two or more consecutive time points | Posted | Number | participants | Over the entire 4 year follow up period (17 - 20 years) |
|
|
|
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 |
| Year 17, HBsAg Positive |
|
| Year 17, Anti HBc Negative |
|
| Year 17, Anti HBc Positive |
|
| Year 17, HBeAg Negative |
|
| Year 17, HBeAg Positive |
|
| Year 17, Anti HBeAg Negative |
|
| Year 17, Anti HBeAg Positive |
|
| Year 18, HBsAg Negative |
|
| Year 18, HBsAg Positive |
|
| Year 18, Anti HBc Negative |
|
| Year 18, Anti HBc Positive |
|
| Year 18, HBeAg Negative |
|
| Year 18, HBeAg Positive |
|
| Year 18, Anti HBeAg Negative |
|
| Year 18, Anti HBeAg Positive |
|
| Year 19, HBsAg Negative |
|
| Year 19, HBsAg Positive |
|
| Year 19, Anti HBc Negative |
|
| Year 19, Anti HBc Positive |
|
| Year 19, HBeAg Negative |
|
| Year 19, HBeAg Positive |
|
| Year 19, Anti HBeAg Negative |
|
| Year 19, Anti HBeAg Positive |
|
| Year 20, HBsAg Negative |
|
| Year 20, HBsAg Positive |
|
| Year 20, Anti HBc Negative |
|
| Year 20, Anti HBc Positive |
|
| Year 20, HBeAg Negative |
|
| Year 20, HBeAg Positive |
|
| Year 20, Anti HBeAg Negative |
|
| Year 20, Anti HBeAg Positive |
|
| Chronic HB carriers among primary study responders |
|