Drugs / V419
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT01553279 | Mar 2012 → Sep 2013 | meningococcal infection, viral infectious disease | MCM Vaccines B.V. | Completed | No outcome recorded |
| Phase 3 | NCT01341639 | May 2011 → Mar 2013 | bacterial infectious disease, viral infectious disease | MCM Vaccines B.V. | Completed | Met primary |
| Phase 3 | NCT01340937 | May 2011 → Dec 2012 | bacterial infectious disease, viral infectious disease | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 3 | NCT01337167 | Apr 2011 → May 2013 | bacterial infectious disease, viral infectious disease | Merck Sharp & Dohme LLC | Completed | Mixed |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2014-10-20 | Merck Sharp & Dohme LLC | Regulatory US FDA Accepts for Review a Biologics License Application for Merck and Sanofi Pasteur’s Investigational Pediatric Hexavalent Vaccine merck.com ↗ |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 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 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | V419 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01341639 ↗ |
| Known as | PR5I | “V419 (PR5I)” NCT01340937 ↗1“V419 (PR5I)” NCT01337167 ↗ |
| Modality | Vaccine | “V419 (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate \[Meningococcal Outer Membrane Protein Complex\], and...” NCT01337167 ↗ |
| Route | Intramuscular | “0.5 mL intramuscular injection” NCT01337167 ↗ |