A Phase 4 interventional study of Engerix-B in Hepatitis B Vaccine, sponsored by GlaxoSmithKline. Completed at 4 sites in 2 countries. Open to participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-02.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Prevention
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
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 106 is close to the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Acute disease and/or fever at the time of enrolment.
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).
Biological: Engerix-B
Intramuscular administration of single challenge dose of Engerix-B vaccine in the deltoid region of the non-dominant arm.
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.
Time frame: 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.
Time frame: 30 days after the challenge dose (Day 30)
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.
Time frame: 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)
Anti-HBs Antibody Concentrations
Anti-HBs antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During the entire study period (Day 0 to Day 30)
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).
| Milestone | HBV Group |
|---|---|
| Started | 103 |
| Completed | 103 |
| Not completed | 0 |
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.
| Percentage of subjects | HBV Group |
|---|---|
| < 6.2 mIU/mL | 66.7 (22.3 to 95.7) |
| ≥ 6.2 mIU/mL | 85.3 (76.5 to 91.7) |
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.
| Percentage of subjects | HBV Group |
|---|---|
| < 6.2 mIU/mL | 100 (54.1 to 100) |
| ≥ 6.2 mIU/mL | 100 (96.2 to 100) |
Percentage of subjects with anti-HBs antibody concentrations ≥ 6.2 mIU/mL, ≥ 10 mIU/mL and ≥ 100 mIU/mL.
| Percentage of subjects | HBV Group |
|---|---|
| ≥ 6.2 mIU/mL [Day 0] | 94.1 (87.5 to 97.8) |
| ≥ 10 mIU/mL [Day 0] | 90.1 (82.5 to 95.1) |
| ≥ 100 mIU/mL [Day 0] | 61.4 (51.2 to 70.9) |
| ≥ 6.2 mIU/mL [Day 7] | 98.0 (93.0 to 99.8) |
| ≥ 10 mIU/mL [Day 7] | 97.0 (91.6 to 99.4) |
| ≥ 100 mIU/mL [Day 7] | 92.1 (85.0 to 96.5) |
| ≥ 6.2 mIU/mL [Day 30] | 100 (96.4 to 100) |
| ≥ 10 mIU/mL [Day 30] | 100 (96.4 to 100) |
| ≥ 100 mIU/mL [Day 30] | 98.0 (93.0 to 99.8) |
Anti-HBs antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.
| mIU/mL | HBV Group |
|---|---|
| At Day 0 | 184.6 (121.5 to 280.3) |
| At Day 7 | 3840.0 (2330.0 to 6328.6) |
| At Day 30 | 48999.1 (33572.7 to 71513.7) |
Assessed solicited local symptoms were injection site pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.
| Participants | HBV Group |
|---|---|
| Any Pain | 40 |
| Any Redness (mm) | 4 |
| Any Swelling (mm) | 3 |
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.
| Participants | HBV Group |
|---|---|
| Any Fatigue | 27 |
| Any Gastrointestinal symptoms | 10 |
| Any Headache | 20 |
| Any Fever | 0 |
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.
| Participants | HBV Group |
|---|---|
| Number of Subjects With Any Unsolicited AEs | 41 |
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.
| Participants | HBV Group |
|---|---|
| Number of Subjects With Any Serious Adverse Events (SAEs) | 0 |
Collected over 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).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HBV Group | 0/103 (0%) | 0/103 (0%) | 75/103 (72.8%) |
| Event | HBV Group |
|---|---|
| Injection site painGeneral disorders | 40/103 |
| FatigueGeneral disorders | 29/103 |
| HeadacheNervous system disorders | 25/103 |
| Gastrointestinal disorderGastrointestinal disorders | 10/103 |
| NasopharyngitisInfections and infestations | 6/103 |
| Back painMusculoskeletal and connective tissue disorders | 4/103 |
| Injection site erythemaGeneral disorders | 4/103 |
| CoughRespiratory, thoracic and mediastinal disorders | 3/103 |
| Injection site swellingGeneral disorders | 3/103 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 3/103 |
| Age, Continuous(Years) | HBV Group |
|---|---|
| Mean | 48.6 ± 5.9 |
| Sex: Female, Male(Participants) | HBV Group |
|---|---|
| Female | 87 |
| Male | 16 |
| Race/Ethnicity, Customized(Participants) | HBV Group |
|---|---|
| White - Caucasian / European Heritage | 103 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Sap, Icf, Csr
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