Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Engerix-B 20µg · 1 trial · 1 indication
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.
| Arm | Type | Description |
|---|---|---|
| 2-Dose Engerix | EXPERIMENTAL | subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month. |
| 3-Dose Engerix | ACTIVE_COMPARATOR | subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively. |
| Name | Type | Description |
|---|---|---|
| Engerix™-B (thiomersal-free) 20µg | BIOLOGICAL | In the primary study: 2 deep intramuscular injections (Months 0, \& 6) |
| 10 μg Engerix™-B (preservative-free) | BIOLOGICAL | In the primary study: 3 deep intramuscular injections (months 0, 1 \& 6) |
| placebo | BIOLOGICAL | In the primary study: 1 deep intramuscular injection (month 1) |
Inclusion Criteria: * Subjects have participated in primary study HBV-280 * Written informed consent will be obtained from each subject and/ or parent or guardian of the subject before the blood-sampling visit of each year
Engerix-B 20µg is a vaccine used for the prevention of Hepatitis B. It is being developed by GSK plc for this infectious disease indication. The vaccine is currently in Phase 3 clinical development, meaning it is investigational and not yet approved for widespread use.
Engerix-B 20µg is developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in preventing Hepatitis B.
Engerix-B 20µg is in Phase 3 clinical development. This phase involves larger studies to confirm the vaccine's efficacy and monitor adverse reactions. As of now, it is still investigational and has not been approved by regulatory authorities.
Engerix-B 20µg has one completed Phase 3 trial with the identifier NCT00343915. This study evaluated the immuno and safety profile of the vaccine in subjects aged 11-15 years. The trial enrolled 267 participants across Australia, Belgium, and Ukraine.
Engerix-B 20µg is being studied as a thio or preservative-free hepatitis B vaccine. The clinical trial NCT00343915 specifically assessed this formulation in adolescents. The vaccine is designed to prevent Hepatitis B infection.