Drugs / Tritanrix-HepB
Tritanrix-HepB
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Tritanrix HepB | — | 2014-01-01 | europa.eu ↗ |
| Approved | EU (EMA) | Tritanrix HepB | — | 1996-07-19 | europa.eu ↗ |
Trials 5 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00291967 | Nov 2002 → ? | diphtheria, haemophilus infectious disease, hepatitis B virus infection, meningococcal infection +2 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT01003431 | Dec 2009 → Aug 2010 | Rotavirus infection, diphtheria, pertussis, tetanus | Merck Sharp & Dohme LLC | Withdrawn | No outcome recorded |
| Phase 3 | NCT00317109 | Apr 2006 → May 2007 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00197275 | Feb → Nov 2006 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, tetanus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00158756 | Sep 2005 → Nov 2006 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
Also used as a comparator or background therapy in 7 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01061541 Comparator | Aug 2003 → Jan 2004 | haemophilus infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT00814710 Comparator | Mar → Nov 2009 | pneumococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00547248 Background | Oct 2007 → May 2008 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00344318 Background | Aug 2006 → Apr 2007 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00291343 Background | Feb 2006 → Mar 2007 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00317187 Background | Jun 2004 → Jan 2005 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, tetanus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00317135 Comparator | Dec 2003 → Oct 2004 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, tetanus | GlaxoSmithKline | Completed | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tritanrix- HepB | “[Intervention name: RotaTeq™ administered concomitantly with Tritanrix™ HepB (DTwP)] Three 2.0 mL oral doses of RotaTeq™ and three 0.5 mL intramuscular injections of Tritanrix™ HepB” NCT01003431 ↗ |
| Known as | DTPw-HBV | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00291967 ↗ |
| Known as | TritanrixTM-HepB | “Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)” NCT00814710 ↗ |
| Modality | Vaccine | “GSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine.” NCT00158756 ↗ |
| Route | Intramuscular | “intramuscularly into the right anterolateral thigh” NCT00158756 ↗ |