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This study will evaluate the immune response of healthy subjects who received neonatal vaccination course with GSK Biologicals' Engerix™-B vaccine, approximately 20 years ago. The presence of immune memory against hepatitis B surface antigen (HBsAg) in these subjects will be investigated by the administration of a challenge dose of hepatitis B vaccine and the comparison of their antibody concentration before and one month after vaccination.
This protocol posting deals with objectives & outcome measures of the booster phase. No new subjects will be recruited during this booster phase of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig) | Experimental | Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. |
|
| Engerix(3-dose)+HBIg | Experimental | Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. |
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| Engerix(4-dose) | Experimental | Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. |
|
| Engerix(3-dose) | Experimental | Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EngerixTM-B | Biological | Intramuscular injection, one dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With an Anamnestic Response to a Challenge Dose of Hepatitis B Virus (HBV) Vaccine as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Anamnestic response to the challenge dose is defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge anti-HBsAg antibody concentrations in subjects seropositive at the last available follow-up time-point. -Post-challenge dose anti-HBsAg antibody concentrations >= 10 mIU/mL in subjects seronegative at the last available follow-up time-point. | One month after the hepatitis B vaccine challenge dose. |
| Number of Subjects With an Anamnestic Response to a Challenge Dose of Hepatitis B Virus (HBV) Vaccine as Measured by ChemiLuminescence ImmunoAssay (CLIA). | Anamnestic response to the challenge dose is defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge anti-HBsAg antibody concentrations in subjects seropositive at the last available follow-up time-point. -Post-challenge dose anti-HBsAg antibody concentrations >= 10 mIU/mL in subjects seronegative at the last available follow-up time-point. | One month after the hepatitis B vaccine challenge dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by ELISA. | Cut-off values assessed were as follows: ≥3.3 milli-international units/milliliter (mIU/mL), ≥10 mIU/mL, ≥100 mIU/mL | One month after the hepatitis B vaccine challenge dose. |
| Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by CLIA. |
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Inclusion Criteria:
Exclusion 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 |
|---|---|---|---|
| 22777097 | Derived | Poovorawan Y, Chongsrisawat V, Theamboonlers A, Leroux-Roels G, Crasta PD, Hardt K. Persistence and immune memory to hepatitis B vaccine 20 years after primary vaccination of Thai infants, born to HBsAg and HBeAg positive mothers. Hum Vaccin Immunother. 2012 Jul;8(7):896-904. doi: 10.4161/hv.19989. Epub 2012 Jul 1. |
| 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 |
|---|---|---|---|
| 110073 | Statistical Analysis Plan | 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 | Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig) | Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. |
| FG001 | Engerix(3-dose)+HBIg | Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. |
| FG002 | Engerix(4-dose) | Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. |
| FG003 | Engerix(3-dose) | Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig) | Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. |
| BG001 |
| 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 | Number of Subjects With an Anamnestic Response to a Challenge Dose of Hepatitis B Virus (HBV) Vaccine as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Anamnestic response to the challenge dose is defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge anti-HBsAg antibody concentrations in subjects seropositive at the last available follow-up time-point. -Post-challenge dose anti-HBsAg antibody concentrations >= 10 mIU/mL in subjects seronegative at the last available follow-up time-point. | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point. | Posted | Number | Subjects | One month after the hepatitis B vaccine challenge dose. |
|
Serious adverse events: During the entire study period i.e. from Day 0 to Month 1; Unsolicited adverse events: During the 31 days (Day 0 to Day 30) post challenge dose.
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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(4-dose)+HepatitisB(HB) Immunoglobulin (Ig) | Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | Non-systematic Assessment |
A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL).The table shows updated results following complete retesting and reanalysis
| 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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Cut-off values assessed were as follows: ≥6.2 milli-international units/milliliter (mIU/mL), ≥10 mIU/mL, ≥100 mIU/mL |
| One month after the hepatitis B vaccine challenge dose. |
| Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ELISA. | Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL). | One month after the hepatitis B vaccine challenge dose. |
| Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by CLIA. | Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL). | One month after the hepatitis B vaccine challenge dose. |
| Number of Subjects Experiencing Any, Grade 3 and Related to Vaccination Unsolicited Symptoms. | Unsolicited 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. Grade 3 symptom is any event that prevented normal activities. Related symptom is an event that was considered by investigator as causally related to the study vaccination. | During the 31-day follow-up period after the hepatitis B vaccine challenge dose. |
| Number of Subjects That Experienced Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are 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 entire study period after the challenge dose (1 month). |
For additional information about this study please refer to the GSK Clinical Study Register |
| 110073 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110073 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110073 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110073 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110073 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Engerix(3-dose)+HBIg |
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. |
| BG002 | Engerix(4-dose) | Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. |
| BG003 | Engerix(3-dose) | Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. |
| OG001 | Engerix(3-dose)+HBIg | Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. |
| OG002 | Engerix(4-dose) | Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. |
| OG003 | Engerix(3-dose) | Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. |
|
|
| Secondary | Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by ELISA. | Cut-off values assessed were as follows: ≥3.3 milli-international units/milliliter (mIU/mL), ≥10 mIU/mL, ≥100 mIU/mL | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point. | Posted | Number | Subjects | One month after the hepatitis B vaccine challenge dose. |
|
|
|
| Secondary | Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by CLIA. | Cut-off values assessed were as follows: ≥6.2 milli-international units/milliliter (mIU/mL), ≥10 mIU/mL, ≥100 mIU/mL | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point. | Posted | Number | Subjects | One month after the hepatitis B vaccine challenge dose. |
|
|
|
| Secondary | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ELISA. | Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL). | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | One month after the hepatitis B vaccine challenge dose. |
|
|
|
| Secondary | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by CLIA. | Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL). | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | One month after the hepatitis B vaccine challenge dose. |
|
|
|
| Primary | Number of Subjects With an Anamnestic Response to a Challenge Dose of Hepatitis B Virus (HBV) Vaccine as Measured by ChemiLuminescence ImmunoAssay (CLIA). | Anamnestic response to the challenge dose is defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge anti-HBsAg antibody concentrations in subjects seropositive at the last available follow-up time-point. -Post-challenge dose anti-HBsAg antibody concentrations >= 10 mIU/mL in subjects seronegative at the last available follow-up time-point. | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point. | Posted | Number | Subjects | One month after the hepatitis B vaccine challenge dose. |
|
|
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| Secondary | Number of Subjects Experiencing Any, Grade 3 and Related to Vaccination Unsolicited Symptoms. | Unsolicited 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. Grade 3 symptom is any event that prevented normal activities. Related symptom is an event that was considered by investigator as causally related to the study vaccination. | Posted | Number | Subjects | During the 31-day follow-up period after the hepatitis B vaccine challenge dose. |
|
|
|
| Secondary | Number of Subjects That Experienced Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are 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. | Posted | Number | Subjects | During the entire study period after the challenge dose (1 month). |
|
|
|
| 0 |
| 9 |
| 1 |
| 9 |
| EG001 | Engerix(3-dose)+HBIg | Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. | 0 | 16 | 0 | 16 |
| EG002 | Engerix(4-dose) | Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. | 0 | 8 | 0 | 8 |
| EG003 | Engerix(3-dose) | Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study. | 0 | 16 | 0 | 16 |
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 |
| ≥ 10 mIU/mL |
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| ≥ 100 mIU/mL |
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| ≥ 10 mIU/mL |
|
| ≥ 100 mIU/mL |
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| Subjects with grade 3 symptoms |
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| Subjects with related symptoms |
|