Drugs / Pentacel
Pentacel
also known as
Vaxelis · DTaP5-HBV-IPV-Hib · PR5I · DPTaP+Hib · DTaP(5)-IPV-Hib · DTaP-IPV/Hib · Vaxelis vaccine
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Vaxelis | — | 2016-02-15 | europa.eu ↗ |
Trials 8 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 37 trials | ||||||
| Phase 3 | NCT04016714 | Aug 2019 → Oct 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03893448 | Jun 2019 → May 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01839188 | May 2013 → Mar 2014 | meningococcal infection, viral infectious disease | MCM Vaccines B.V. | Completed | No outcome recorded |
| Phase 3 | NCT01480258 | Nov 2011 → Oct 2013 | bacterial infectious disease, viral infectious disease | MCM Vaccines B.V. | Completed | No outcome recorded |
| Phase 3 | NCT01340937 | May 2011 → Dec 2012 | bacterial infectious disease, viral infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00255047 | Nov 2005 → Jul 2008 | diphtheria, pertussis, poliomyelitis | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT00772928 | Oct 2003 → May 2006 | diphtheria, haemophilus infectious disease, pertussis, poliomyelitis +1 | Sanofi | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05289271 | Mar → Aug 2022 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
Also used as a comparator or background therapy in 15 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT00551915 Comparator | May 2001 → Jan 2003 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00729001 Background | Nov 2000 → Sep 2002 | Rotavirus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT06824181 Background | Feb 2025 → Sep 2027 expected | — | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06824194 Background | Feb 2025 → Oct 2027 expected | — | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06736041 Background | Dec 2024 → May 2027 expected | — | Sanofi Pasteur, a Sanofi Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03620162 Background | Oct 2018 → Dec 2020 | pneumococcal infection | Merck Sharp & Dohme LLC | 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 | NCT01337167 Comparator | Apr 2011 → May 2013 | bacterial infectious disease, viral infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01000974 Comparator | Jun 2010 → Nov 2011 | haemophilus infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00662870 Comparator | May 2001 → Jan 2004 | diphtheria, haemophilus infectious disease, pertussis, poliomyelitis +1 | Sanofi | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT05856396 Comparator | Sep 2023 → Dec 2025 | pertussis | Centre Hospitalier Universitaire Saint Pierre | Completed | No outcome recorded |
| Phase 4 | NCT04978818 Comparator | Jan 2022 → Oct 2023 | haemophilus infectious disease | Johns Hopkins Bloomberg School of Public Health | Completed | No outcome recorded |
| Phase 4 | NCT04535037 Comparator | May 2021 → Jul 2022 | diphtheria | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT01659996 Comparator | Jul 2012 → Nov 2014 | diphtheria, haemophilus meningitis, meningococcal infection, pertussis +1 | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 4 | NCT00390130 Comparator | Jul 2006 → Jun 2007 | — | The Hospital for Sick Children | Completed | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pentacel | “Healthy infants were randomized (2:2:2:1) to receive HV or Pentacel (Control)” PMID 27846058 ↗ Feb 2017 |
| Known as | DPTaP+Hib | “Pentacel (DPTaP+Hib) is a relatively painless vaccine to administer” NCT00390130 ↗ |
| Known as | DTaP(5)-IPV-Hib | “combination vaccine (DTaP(5)-IPV-Hib; Pentacel)” PMID 19117896 ↗ Jan 2009 |
| Known as | DTaP-IPV/Hib | “Pentacel: DTaP-IPV/Hib” NCT00662870 ↗ |
| Known as | DTaP5-HBV-IPV-Hib | “DTaP5-HBV-IPV-Hib (Vaxelis®) is a hexavalent combination vaccine (HV)” PMID 38327239 ↗ Feb 2024 |
| Known as | PR5I | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01480258 ↗ |
| Known as | Vaxelis | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05289271 ↗ |
| Known as | Vaxelis vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06824181 ↗ |
| Modality | Vaccine | “The subjects in this arm will be vaccinated with Pentacel” NCT00390130 ↗ |
| Route | Intramuscular | “0.5 ml each of PENTACEL™ + RECOMBIVAX HB™ via intramuscular injection” NCT00551915 ↗ |