Drugs / TWINRIX™ ADULT
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Twinrix Adult | — | 1996-09-19 | europa.eu ↗ |
Trials 2 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT00289744 | Feb 2004 → Apr 2009 | hepatitis A virus infection, hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00197171 | Sep → Dec 2003 | hepatitis A virus infection, hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT00197119 Comparator | May → Jun 2004 | hepatitis A virus infection, hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00197184 Comparator | Nov 2003 → Mar 2004 | hepatitis A virus infection, hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Twinrix Adult | “Evaluate the Persistence of Immune Response of GSK Biologicals' TWINRIX™ ADULT, Administered According to 0,6 Month Schedule and 0,12 Month Schedule, in Volunteers Aged 12-15...” NCT00197171 ↗ |
| Modality | Vaccine | “2 Formulations of Combined Hepatitis A/B Vaccine Compared” NCT00197119 ↗ |
| Route | Intramuscular | “Intramuscular administration in the deltoid region (2 doses).” NCT00197119 ↗ |