drugset
Drugs / Tritanrix-HepB
last change Jan 2014 re-read 9 days ago

Tritanrix-HepB

also known as TritanrixTM-HepB

Vaccine

Developed for
diphtheria · hepatitis B virus infection · tetanus · haemophilus infectious disease · pertussis
Investigated by
GlaxoSmithKline · Merck Sharp & Dohme LLC

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence 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Withdrawn EU (EMA) Tritanrix HepB — 2014-01-01 europa.eu ↗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 4

today
EU approved 1996
NCT01003431 · Ph 3 NCT00317109 · Ph 3 NCT00197275 · Ph 3 NCT00158756 · Ph 3
19961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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Phase 3 NCT01003431 Dec 2009 → Aug 2010 Rotavirus infection, diphtheria, pertussis, tetanus Merck Sharp & Dohme LLC Withdrawn No outcome recorded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
Comparator or background therapy7 trials
Phase 2 NCT01061541 Comparator Aug 2003 → Jan 2004 haemophilus infectious disease GlaxoSmithKline Completed No outcome recorded
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

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 11 sources stand behind the page.

FieldValueCited 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 ↗
10

NCT00197275 ↗

NCT00317187 ↗

NCT00344318 ↗

NCT00291343 ↗

NCT01061541 ↗

NCT00317135 ↗

NCT00158756 ↗

NCT00814710 ↗

NCT00547248 ↗

NCT00317109 ↗
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 ↗