Drugs / Pentacel
Pentacel
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 34 trials | ||||||
| Phase 3 | NCT03893448 | Jun 2019 → May 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 3 | NCT01340937 | May 2011 → Dec 2012 | bacterial infectious disease, viral infectious disease | Merck Sharp & Dohme LLC | Completed | Mixed |
| 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 |
| Comparator or background therapy9 trials | ||||||
| Phase 2 | NCT00551915 Comparator | May 2001 → Jan 2003 | — | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 2 | NCT00729001 Background | Nov 2000 → Sep 2002 | Rotavirus infection | GlaxoSmithKline | Completed | 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 | Mixed |
| 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 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 |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2024-06-27 | Merck Sharp & Dohme LLC | Regulatory CDC’s ACIP Unanimously Votes to Add Merck and Sanofi’s Pediatric Hexavalent Combination Vaccine to its Preferential Recommendation to Help Prevent Invasive Hib Disease in American Indian and Alaska Native Infants merck.com ↗ |
| 2018-12-24 | Merck Sharp & Dohme LLC | Regulatory FDA Approves VAXELIS™, Merck and Sanofi’s Pediatric Hexavalent Combination Vaccine merck.com ↗
The U.S. Food and Drug Administration has approved VAXELIS™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine) for use in children from 6 weeks through 4 years of age (prior to the 5th birthday). |
| 2014-10-20 | Merck Sharp & Dohme LLC | Results US FDA Accepts for Review a Biologics License Application for Merck and Sanofi Pasteur’s Investigational Pediatric Hexavalent Vaccine merck.com ↗
For 18 of these 19 comparisons (all but one pertussis comparison), the antibodies in the Group 1 infants were non-inferior to those in the Group 2 infants. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-06-27 | Merck Sharp & Dohme LLC | CDC’s ACIP Unanimously Votes to Add Merck and Sanofi’s Pediatric Hexavalent Combination Vaccine to its Preferential Recommendation to Help Prevent Invasive Hib Disease in American Indian and Alaska Native Infants merck.com ↗ |
| 2018-12-24 | Merck Sharp & Dohme LLC | FDA Approves VAXELIS™, Merck and Sanofi’s Pediatric Hexavalent Combination Vaccine merck.com ↗ |
| 2014-10-20 | Merck Sharp & Dohme LLC | US FDA Accepts for Review a Biologics License Application for Merck and Sanofi Pasteur’s Investigational Pediatric Hexavalent Vaccine merck.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 15 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 ↗ |
| 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 ↗ |