Drugs / Hexaxim
Hexaxim
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Hexyon | — | 2013-04-17 | europa.eu ↗ |
| Refused (EMA) | EU (EMA) | Hexyon | — | 2013-02-22 | europa.eu ↗ |
Trials 3 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02817451 | Jul 2016 → Feb 2019 | HIV infectious disease, diphtheria, hepatitis B virus infection, pertussis +2 | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT02428491 | Apr 2015 → Jan 2017 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, pertussis +2 | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT01948193 | Feb → Dec 2014 | diphtheria, hepatitis B virus infection, pertussis, poliomyelitis +1 | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT06618196 Comparator | Oct 2024 → Jun 2025 overdue | diphtheria, haemophilus infectious disease, hepatitis B virus infection, pertussis +2 | LG Chem | Not yet recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06975878 Background | May 2025 → Aug 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 | NCT05794230 Background | Mar 2023 → Nov 2025 | meningococcal infection | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Hexaxim | “DTaP-HepB-IPV-Hib hexavalent vaccine LR20062 Versus Hexaxim Administered Intramuscularly in Healthy Infants” NCT06618196 ↗ |
| Known as | DTaP-IPV-Hib-HepB vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05794230 ↗ |
| Known as | Hexyon | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06975878 ↗ |
| Modality | Vaccine | “fully liquid combined hexavalent vaccine (Hexaxim®)” NCT02428491 ↗ |
| Route | Intramuscular | “0.5 mL, Intramuscular” NCT01948193 ↗ |