Drugs / Vaqta
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03312699 | Sep 2017 → Dec 2023 | hepatitis A virus infection, influenza, typhoid fever | Stanford University | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT03893448 | Jun 2019 → May 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 3 | NCT00835380 | Mar → Oct 2008 | hepatitis A virus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 42 trials · 1 met primary | ||||||
| Phase 4 | NCT00603252 | Jan → Jun 2008 | hepatitis A virus infection, hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00289913 | Apr 2006 → Jun 2010 | hepatitis A virus infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase not applicable1 trial · 1 met primary | ||||||
| — | NCT00139139 | Sep 2003 → May 2005 | hepatitis A virus infection | Centers for Disease Control and Prevention | Completed | Met primary |
| Comparator or background therapy7 trials | ||||||
| Phase 3 | NCT06824181 Background | Feb 2025 → Sep 2027 expected | — | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06824194 Background | Feb 2025 → Oct 2027 expected | — | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT00785967 Background | Jan 2009 → Aug 2011 | HIV infectious disease | McGill University Health Centre/Research Institute of the McGill University Health Centre | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00684671 Comparator | May → Nov 2008 | hepatitis A virus infection, hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00326183 Comparator | Mar 2007 → Jan 2008 | chickenpox, hepatitis A virus infection, measles, mumps infectious disease +1 | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT00312858 Comparator | Apr 2006 → Mar 2008 | hepatitis A virus infection | Merck Sharp & Dohme LLC | 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 |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2019-06-27 | Merck Sharp & Dohme LLC | Regulatory CDC Advisory Committee on Immunization Practices (ACIP) Unanimously Votes to Provisionally Update Recommendations for Hepatitis A Vaccination merck.com ↗
ACIP unanimously voted to recommend that all children and adolescents aged 2 through 18 years who have not previously received hepatitis A vaccine be vaccinated routinely at any age (i.e., children and adolescents are recommended for catch-up vaccination). |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2019-06-27 | Merck Sharp & Dohme LLC | CDC Advisory Committee on Immunization Practices (ACIP) Unanimously Votes to Provisionally Update Recommendations for Hepatitis A Vaccination merck.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vaqta | “Open-label, multicenter, randomized study (NCT00289913) evaluated
immunogenicity, safety, and tolerability of Vaqta (hepatitis A vaccine)
administered with PedvaxHIB” PMID 26308112 ↗ 201614“Within an exposed group, subjects will be randomized to receive either hepatitis A vaccine, VAQTA™, or immune globulin (IG) intramuscular (IM).” NCT00139139 ↗ “and Vaqta™ (50 IU) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.” NCT00289731 ↗ “VAQTA: 1.0ml IM at weeks 24 \& 48” NCT00785967 ↗ |
| Known as | HAV | “This open-label, multicenter, randomized, comparative study evaluated immunogenicity, safety and tolerability of concomitant (Group 1; n=330) vs. non-concomitant (Group 2;...” PMID 23744509 ↗ Jun 2013 |
| Modality | Vaccine | “Hepatitis A Vaccine, Inactivated” NCT00289913 ↗ |
| Route | Intramuscular | “Two intramuscular 0.5-mL doses of VAQTA™ were administered” NCT00289913 ↗ |