Drugs / Vaxelis
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 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT04016714 | Aug 2019 → Oct 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT05289271 | Mar → Aug 2022 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| 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 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 |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2018-12-24 | Merck Sharp & Dohme LLC | FDA Approves VAXELIS™, Merck and Sanofi’s Pediatric Hexavalent Combination Vaccine merck.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vaxelis | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04016714 ↗ |
| Known as | DTaP5-HBV-IPV-Hib | “DTaP5-HBV-IPV-Hib (Vaxelis®) is a hexavalent combination vaccine (HV)” PMID 38327239 ↗ Feb 2024 |
| Modality | Vaccine | “other pediatric vaccines, including Vaxelis™” NCT04016714 ↗ |
| Route | Intramuscular | “for intramuscular administration” NCT05289271 ↗ |