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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004099-31 | EudraCT Number |
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The purpose of this study is to assess the long-term protection against HBV infection in adult subjects, aged 18-40 years vaccinated with three or four doses of Engerix-B 20 to 30 years ago
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBV Group | Experimental | Subjects aged 40 to 60 years old who received 3 or 4 doses of Engerix-B (HBV vaccine) 20 to 30 years ago and were administered with a single challenge dose of HBV vaccine in this study at Day 0 (Visit 1). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engerix-B | Biological | Intramuscular administration of single challenge dose of Engerix-B vaccine in the deltoid region of the non-dominant arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With an Anamnestic Response to the HBV Challenge Dose, Based on the Last Available Time Point Before the Challenge Dose | Anamnestic response to the challenge dose was defined as: At least (i.e. greater than or equal to [≥]) 4-fold rise in one month post-vaccination anti-hepatitis B surface antigen (anti-HBs) antibody concentrations in previously seropositive subjects (Subjects with anti-HBs antibody concentration ≥ 6.2 milli International Unit/Milliliter (mIU/mL) at the pre-challenge dose time point); In previously seronegative subjects (Subjects with anti-HBs antibody concentration < 6.2 mIU/mL at the pre-challenge dose time point), anti-HBs antibody concentrations ≥10 mIU/mL at one month post-challenge dose time-point. | 7 days after the challenge dose (Day 7) |
| Percentage of Subjects With an Anamnestic Response to the HBV Challenge Dose, Based on the Last Available Time Point Before the Challenge Dose | Anamnestic response to the challenge dose was defined as: At least (i.e. ≥ 4-fold rise in one month post-vaccination anti-HBs antibody concentrations in previously seropositive subjects (Subjects with anti-HBs antibody concentration ≥ 6.2 mIU/mL at the pre-challenge dose time point); In previously seronegative subjects (Subjects with anti-HBs antibody concentration < 6.2 mIU/mL at the pre-challenge dose time point), anti-HBs antibody concentrations ≥10 mIU/mL at one month post-challenge dose time-point. | 30 days after the challenge dose (Day 30) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Cut-off Values | Percentage of subjects with anti-HBs antibody concentrations ≥ 6.2 mIU/mL, ≥ 10 mIU/mL and ≥ 100 mIU/mL. | At the pre-challenge dose time-point (Day 0), at 7 days post-challenge time-point (Day 7) and at 30 days post-challenge time-point (Day 30) |
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Inclusion Criteria:
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
A male or female between and including 40 and 60 years of age (from and including the 40th birthday up to, but excluding, the 61st birthday) at the time of the vaccination.
Written informed consent obtained from the subject.
Documented evidence of previous vaccination with three or four consecutive doses of Engerix-B administered in adulthood (i.e. at least 18 years of age) with
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
Administration of long-acting immune-modifying drugs at any time during the study period.
Previous hepatitis B booster vaccination since completion of the primary vaccination series with three or four doses of Engerix-B.
Planned administration of a vaccine not foreseen by the study protocol within 30 days preceding the dose of study vaccine, or planned administration during the study period, with the exception of seasonal influenza vaccine.
Any medical condition that in the judgment of the investigator places the subject at undue risk by participating in the study.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
History of hepatitis B disease or episode of jaundice with unknown etiology.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Major congenital defects or serious chronic illness (including insulin-dependent diabetes).
Acute disease and/or fever at the time of enrolment.
Administration of immunoglobulins and/or any blood products during the period starting 3 months before the dose of study vaccine, or planned administration during the study period.
Drug and/ or alcohol abuse within the last 5 years.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ghent | 9000 | Belgium | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31087382 | Background | Van Damme P, Dionne M, Leroux-Roels G, Van Der Meeren O, Di Paolo E, Salaun B, Surya Kiran P, Folschweiller N. Persistence of HBsAg-specific antibodies and immune memory two to three decades after hepatitis B vaccination in adults. J Viral Hepat. 2019 Sep;26(9):1066-1075. doi: 10.1111/jvh.13125. Epub 2019 Jun 2. |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
106 subjects were enrolled in the study but 3 subjects were withdrawn before vaccine administration. Therefore, the number of subjects started is 103.
Subjects aged between and including 40 to 60 years were enrolled in this study, in compliance with the inclusion criteria, which required the documented evidence of previous vaccination with three or four consecutive doses of Engerix-B administered in adulthood (i.e. at least 18 years of age).
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| ID | Title | Description |
|---|---|---|
| FG000 | HBV Group | Subjects aged 40 to 60 years old who received 3 or 4 doses of Engerix-B (HBV vaccine) 20 to 30 years ago and were administered with a single challenge dose of HBV vaccine in this study at Day 0 (Visit 1). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 2, 2016 | Apr 25, 2018 |
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| Anti-HBs Antibody Concentrations |
Anti-HBs antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. |
| At the pre-challenge dose time-point (Day 0), at 7 days post-challenge dose time-point (Day 7) and at 30 days post-challenge dose time-point (Day 30) |
| Number of Subjects With Any Solicited Local Adverse Events (AEs) | Assessed solicited local symptoms were injection site pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. | During the 4-day (Days 0-3) follow-up period after the challenge dose |
| Number of Subjects With Any Solicited General AEs | Assessed solicited general symptoms were fatigue, fever (defined as axillary temperature ≥ 37.5 degrees Celsius [°C]) , gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain) and headache. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. | During the 4-day (Days 0-3) follow-up period after the challenge dose |
| Number of Subjects With Any Unsolicited AEs | An 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. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. | During the 31-day (Days 0-30) follow-up period after the challenge dose |
| Number of Subjects With Any Serious Adverse Events (SAEs) | SAEs assessed included any untoward medical occurrences that resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. | During the entire study period (Day 0 to Day 30) |
| Wilrijk |
| 2610 |
| Belgium |
| GSK Investigational Site | Québec | Quebec | G1E 7G9 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1H 2G2 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | HBV Group | Subjects aged 40 to 60 years old who received 3 or 4 doses of HBV vaccine 20 to 30 years ago and were administered with a single challenge dose of HBV vaccine in this study at Day 0 (Visit 1). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 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 | Percentage of Subjects With an Anamnestic Response to the HBV Challenge Dose, Based on the Last Available Time Point Before the Challenge Dose | Anamnestic response to the challenge dose was defined as: At least (i.e. greater than or equal to [≥]) 4-fold rise in one month post-vaccination anti-hepatitis B surface antigen (anti-HBs) antibody concentrations in previously seropositive subjects (Subjects with anti-HBs antibody concentration ≥ 6.2 milli International Unit/Milliliter (mIU/mL) at the pre-challenge dose time point); In previously seronegative subjects (Subjects with anti-HBs antibody concentration < 6.2 mIU/mL at the pre-challenge dose time point), anti-HBs antibody concentrations ≥10 mIU/mL at one month post-challenge dose time-point. | Analysis was performed on the According-to-protocol (ATP) cohort for analysis of immunogenicity which included all evaluable subjects who had received the challenge dose of HRV vaccine and for whom data concerning immunogenicity outcome measures at pre-challenge (Day 0) and one month post-challenge (Day 30) were available. | Posted | Number | 95% Confidence Interval | Percentage of subjects | 7 days after the challenge dose (Day 7) |
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| Primary | Percentage of Subjects With an Anamnestic Response to the HBV Challenge Dose, Based on the Last Available Time Point Before the Challenge Dose | Anamnestic response to the challenge dose was defined as: At least (i.e. ≥ 4-fold rise in one month post-vaccination anti-HBs antibody concentrations in previously seropositive subjects (Subjects with anti-HBs antibody concentration ≥ 6.2 mIU/mL at the pre-challenge dose time point); In previously seronegative subjects (Subjects with anti-HBs antibody concentration < 6.2 mIU/mL at the pre-challenge dose time point), anti-HBs antibody concentrations ≥10 mIU/mL at one month post-challenge dose time-point. | Analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects who had received the challenge dose of HRV vaccine and for whom data concerning immunogenicity outcome measures at pre-challenge (Day 0) and one month post-challenge (Day 30) were available. | Posted | Number | 95% Confidence Interval | Percentage of subjects | 30 days after the challenge dose (Day 30) |
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| Secondary | Percentage of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Cut-off Values | Percentage of subjects with anti-HBs antibody concentrations ≥ 6.2 mIU/mL, ≥ 10 mIU/mL and ≥ 100 mIU/mL. | Analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects who had received the challenge dose of HRV vaccine and for whom data concerning immunogenicity outcome measures at pre-challenge (Day 0) and one month post-challenge (Day 30) were available. | Posted | Number | 95% Confidence Interval | Percentage of subjects | At the pre-challenge dose time-point (Day 0), at 7 days post-challenge time-point (Day 7) and at 30 days post-challenge time-point (Day 30) |
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| Secondary | Anti-HBs Antibody Concentrations | Anti-HBs antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. | Analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects who had received the challenge dose of HRV vaccine and for whom data concerning immunogenicity outcome measures at pre-challenge (Day 0) and one month post-challenge (Day 30) were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At the pre-challenge dose time-point (Day 0), at 7 days post-challenge dose time-point (Day 7) and at 30 days post-challenge dose time-point (Day 30) |
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| Secondary | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Assessed solicited local symptoms were injection site pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. | Analysis was performed on the Total Vaccinated cohort (TVC) which included all subjects who received the challenge dose. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) follow-up period after the challenge dose |
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| Secondary | Number of Subjects With Any Solicited General AEs | Assessed solicited general symptoms were fatigue, fever (defined as axillary temperature ≥ 37.5 degrees Celsius [°C]) , gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain) and headache. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. | Analysis was performed on the TVC which included all subjects who received the challenge dose. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) follow-up period after the challenge dose |
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| Secondary | Number of Subjects With Any Unsolicited AEs | An 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. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. | Analysis was performed on the TVC which included all subjects who received the challenge dose. | Posted | Count of Participants | Participants | During the 31-day (Days 0-30) follow-up period after the challenge dose |
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| Secondary | Number of Subjects With Any Serious Adverse Events (SAEs) | SAEs assessed included any untoward medical occurrences that resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. | Analysis was performed on the TVC which included all subjects who received the challenge dose. | Posted | Count of Participants | Participants | During the entire study period (Day 0 to Day 30) |
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Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
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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 | HBV Group | Subjects aged 40 to 60 years old who received 3 or 4 doses of HBV vaccine 20 to 30 years ago and were administered with a single challenge dose of HBV vaccine in this study at Day 0 (Visit 1). | 0 | 103 | 0 | 103 | 75 | 103 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Frequent bowel movements | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
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| Joint warmth | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Lip swelling | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Menopausal symptoms | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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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 | sk994601@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 12, 2017 | Apr 25, 2018 | SAP_001.pdf |
| 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 |
|---|---|
| C075654 | Engerix-B |
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