Drugs / Infanrix™ penta
last change May 2013 re-read 3 minutes ago

Infanrix™ penta

Vaccine

Developed for
diphtheria · hepatitis B virus infection · poliomyelitis · tetanus
Investigated by
GlaxoSmithKline

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Withdrawn EU (EMA) Infanrix Penta — 2013-05-30 europa.eu ↗
Approved EU (EMA) Infanrix Penta — 2000-10-23 europa.eu ↗

Trials 2

200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 32 trials
Phase 3 NCT00463437 Apr 2007 → Jan 2008 diphtheria, hepatitis B virus infection, pneumococcal infection, poliomyelitis +1 GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT00327184 Apr → Nov 2006 haemophilus infectious disease, meningococcal infection GlaxoSmithKline Completed No outcome recorded
Comparator or background therapy6 trials
Phase 2 NCT00134719 Background Apr 2005 → Jul 2006 haemophilus infectious disease, meningococcal infection GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT00129116 Background Mar → Dec 2003 haemophilus infectious disease, meningococcal infection GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT00127855 Background Mar 2003 → Feb 2004 haemophilus infectious disease, meningococcal infection GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT00586612 Background Dec 2007 → Dec 2008 haemophilus infectious disease, meningococcal infection GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT00322335 Background May → Jul 2006 haemophilus infectious disease, meningococcal infection GlaxoSmithKline Completed No outcome recorded

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 8 sources stand behind the page.

FieldValueCited text
Known as Infanrix penta “Subjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of Hib-MenC + Infanrix™ penta vaccines.” NCT00327184 ↗
8

NCT00327184 ↗

NCT00322335 ↗

NCT00129116 ↗

NCT00127855 ↗

NCT00134719 ↗

NCT00586612 ↗

NCT00463437 ↗

NCT00611559 ↗

Modality Vaccine “DTPa-HBV-IPV vaccine” NCT00127855 ↗
Route Intramuscular “Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.” NCT00127855 ↗