Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00343915 | Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs | PHASE3 | COMPLETED | 267 | — | — | Apr 21, 2004 | Jan 10, 2008 | Jun 10, 2019 | 4 | Australia, Belgium +1 |
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