Drugs / Pediarix
Pediarix
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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| Withdrawn | EU (EMA) | Infanrix Penta | — | 2013-05-30 | europa.eu ↗ |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 6 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT00505063 | Jul 2007 → Jun 2025 | childhood malignant neoplasm | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00133445 | Dec 2005 → Aug 2006 | diphtheria, hepatitis B virus infection, pertussis, poliomyelitis +1 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT01000974 | Jun 2010 → Nov 2011 | haemophilus infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| 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 |
| Phase 3 | NCT00879827 | Sep 2000 → May 2001 | diphtheria, hepatitis B virus infection, poliomyelitis, tetanus | GlaxoSmithKline | Completed | No outcome recorded |
Also used as a comparator or background therapy in 14 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 24 trials | ||||||
| Phase 2 | NCT00134719 Background | Apr 2005 → Jul 2006 | haemophilus infectious disease, meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00129129 Background | Aug 2004 → Sep 2005 | 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 2 | NCT00129116 Background | Mar → Dec 2003 | haemophilus infectious disease, meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 39 trials | ||||||
| Phase 3 | NCT07160244 Background | Aug 2025 → Nov 2028 expected | — | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT03621670 Background | Jul 2018 → Dec 2024 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT03207750 Background | Sep 2017 → Oct 2018 | Rotavirus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02096263 Comparator | Apr 2014 → Feb 2015 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01978093 Background | Feb 2014 → Mar 2016 | haemophilus infectious disease, meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00614614 Background | Feb 2008 → Jul 2009 | 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 |
| Phase 3 | NCT00289783 Background | Feb 2006 → Aug 2007 | haemophilus infectious disease, meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00611559 Comparator | Feb → Jun 2008 | diphtheria, hepatitis B virus infection, poliomyelitis, tetanus | GlaxoSmithKline | Completed | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pediarix | “With the recent licensure in the US of a pentavalent combination vaccine (DTaP-Hep B-IPV; Pediarix™) researchers propose to evaluate a new immunization schedule that includes a...” NCT00133445 ↗ |
| Known as | DTaP-HepB-IPV | “DTaP-HepB-IPV (Pediarix™) vaccine” NCT00133445 ↗ |
| Known as | DTPa-HBV-IPV | “Pediarix (DTPa-HBV-IPV) was administered intramuscularly on Day 1, Day 61, and Day 121.” NCT03621670 ↗ |
| 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 ↗9“Pediarix TM, Infanrix penta TM” NCT00879827 ↗ |
| 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 ↗ |