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
Top 6 of 8 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Gilead Sciences, Inc. | GILD | 3 | PHASE3 | Viread, Tenofovir alafenamide |
| Vir Biotechnology, Inc. | VIR | 6 | PHASE3 | Tobevibart, Elebsiran |
| Bausch Health Companies Inc. | BHC | 1 | PHASE3 | Larsucosterol |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Daplusiran/Tomligisiran, Bepirovirsen |
| Aligos Therapeutics, Inc. | ALGS | 1 | PHASE2 | ALG-000184 |
| Precision BioSciences, Inc. | DTIL | 2 | PHASE1 | PBGENE-HBV |
Engerix-B 20µg is a hepatitis B vaccine used to prevent hepatitis B infection. It is given as an active-controlled Phase 3 study product in subjects aged 11 to 15 years. The clinical program enrolled 267 healthy volunteers across Australia, Belgium, and Ukraine.
Engerix-B 20µg is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals conducted the clinical study of the thiomersal-free or preservative-free formulation of the hepatitis B vaccine.
Engerix-B 20µg has been studied in a Phase 3 clinical trial, and that trial is now completed. It is an investigational presentation evaluated in a single Phase 3 study of 267 healthy volunteers aged 11 to 15 years; no trials are currently active.
Engerix-B 20µg was evaluated in the Phase 3 trial NCT00343915, titled Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs. The completed study enrolled 267 healthy volunteers in Australia, Belgium, and Ukraine and used an active control.