Drugs / HBVAXPRO
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | HBVaxPro | — | 2001-04-27 | europa.eu ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02186977 | Mar → Dec 2016 | hepatitis B virus infection | Novosanis NV | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT04490499 | Sep → Dec 2020 | hepatitis B virus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02012998 | Jan 2014 → Feb 2015 | hepatitis B virus infection | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT01251276 | Nov 2010 → Apr 2011 | hepatitis B virus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00693186 | Oct 2008 → Dec 2009 | hepatitis B virus infection | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT01821547 | Mar 2013 → Apr 2014 | hepatitis B virus infection | University of Oxford | Completed | No outcome recorded |
| Phase 4 | NCT00603252 | Jan → Jun 2008 | hepatitis A virus infection, hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00230061 | Apr 2004 → May 2008 | HIV infectious disease, hepatitis B virus infection | Erasmus Medical Center | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT03459521 | Sep 2017 → Aug 2021 | hepatitis B virus infection | Corporacion Parc Tauli | Completed | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 1 | NCT02540538 Comparator | Sep 2015 → Jul 2016 | hepatitis B virus infection | Maastricht University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT03415672 Comparator | Oct 2017 → Jan 2019 | hepatitis B virus infection | Maastricht University Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT00291980 Comparator | Mar 2006 → Oct 2007 | hepatitis B virus infection | Henogen | Completed | No outcome recorded |
| Phase 3 | NCT00291954 Comparator | Mar 2006 → Oct 2007 | hepatitis B virus infection | Henogen | Completed | No outcome recorded |
| Phase 4 | NCT00684671 Comparator | May → Nov 2008 | hepatitis A virus infection, hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00289731 Comparator | Nov 2003 → Dec 2004 | hepatitis A virus infection, hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HBVaxPro | “Children received a single intramuscular challenge dose of either hepatitis B vaccine, HBVaxPro (Hexavac, n=34; Infanrix-Hexa, n=28) or Engerix-B (Hexavac, n=167; Infanrix-Hexa, n=181).” PMID 22789511 ↗ Jul 201216“who received separate administrations of HB VAX PRO™ (10 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule” NCT00289731 ↗ “Immunisation with HepB vaccine (HBvaxPRO, 10μg/ml, Sanofi Pastuer) via intramuscular injection into the non-dominant deltoid (part 1 only).” NCT01821547 ↗ “The safety profile of this challenge dose of HBvaxPRO® was consistent with the well-established safety profile of the vaccine HBvaxPRO®.” PMID 25996838 ↗ 2015 |
| Known as | HBvaxPRO, 10μg/ml, Sanofi Pastuer | “HBvaxPRO, 10μg/ml, Sanofi Pastuer” NCT01821547 ↗ |
| Modality | Vaccine | “Hepatitis B (Recombinant) vaccine” NCT00230061 ↗ |
| Route | Intramuscular | “Children received a single intramuscular challenge dose of either hepatitis B vaccine, HBVaxPro (Hexavac, n=34; Infanrix-Hexa, n=28) or Engerix-B (Hexavac, n=167; Infanrix-Hexa, n=181).” PMID 22789511 ↗ Jul 2012 |