Drugs / Havrix
Havrix
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01360970 | Sep 2009 → May 2011 | — | Lars Rombo | Completed | No outcome recorded |
| Phase 310 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT02082639 | Feb → Aug 2015 | human papilloma virus infection | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 3 | NCT01352793 | Nov 2012 → Sep 2014 | meningococcal meningitis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01379937 | Jul 2011 → Aug 2012 | influenza | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00839254 | Feb 2009 → Jan 2012 | pneumococcal infection | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00466947 | Jun 2007 → Aug 2010 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00197236 | Nov 2003 → Dec 2007 | hepatitis A virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00197015 | Oct 2003 → Jun 2009 | hepatitis A virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00197002 | Sep 2003 → Jan 2006 | hepatitis A virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00190242 | Jun 2003 → Oct 2006 | HIV infectious disease | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 3 | NCT00057330 | Jan 2003 → Aug 2009 | herpes simplex infectious disease | GlaxoSmithKline | Completed | Missed primary |
| Phase 48 trials | ||||||
| Phase 4 | NCT06277882 | Feb 2024 → Mar 2025 | cirrhosis of liver, hepatitis A virus infection | Mahidol University | Unknown | No outcome recorded |
| Phase 4 | NCT03183492 | May 2018 → Jan 2019 | hepatitis A virus infection | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 4 | NCT01252680 | Apr 2010 → Feb 2011 | hepatitis A virus infection | Sinovac Biotech Co., Ltd | Completed | No outcome recorded |
| Phase 4 | NCT01037114 | Jan 2010 → Feb 2014 | hepatitis A virus infection, hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT01000324 | Nov 2009 → Jul 2014 | hepatitis A virus infection, hepatitis B virus infection | GlaxoSmithKline | 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 | NCT00289757 | Jan 2004 → Mar 2013 | hepatitis A virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00291876 | Jan 2004 → Mar 2013 | hepatitis A virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Comparator or background therapy26 trials | ||||||
| Phase 2 | NCT03917654 Comparator | Apr 2019 → Jul 2021 | malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT02212457 Background | Aug 2014 → May 2015 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01282216 Comparator | Apr 2011 → Jan 2016 | cancer-related condition | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00861744 Background | Jun 2009 → Jul 2010 | measles, mumps infectious disease, rubella | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00578175 Background | Nov 2007 → Feb 2009 | chickenpox, measles, mumps infectious disease, rubella | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00513409 Background | Aug 2007 → Feb 2008 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| 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 | NCT05012787 Comparator | Nov 2021 → Mar 2022 | COVID-19 | Clover Biopharmaceuticals AUS Pty | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01978093 Background | Feb 2014 → Mar 2016 | haemophilus infectious disease, meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01830855 Comparator | Apr 2013 → Apr 2015 | meningococcal infection | Pfizer | Completed | Met primary |
| Phase 3 | NCT01702428 Background | Nov 2012 → Nov 2014 | measles, mumps infectious disease, rubella | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01681992 Background | Oct 2012 → Feb 2015 | measles, mumps infectious disease, rubella | GlaxoSmithKline | Completed | Mixed |
| Phase 3 | NCT01218308 Comparator | Dec 2010 → Jan 2012 | influenza | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00861380 Comparator | May 2009 → Jan 2012 | pneumococcal infection | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00624819 Background | Mar → Jun 2008 | pneumococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00316706 Comparator | Oct 2005 → Jan 2009 | cervical intraepithelial neoplasia, human papilloma virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00596271 Comparator | Sep 2005 → Jul 2006 | Japanese encephalitis | Valneva Austria GmbH | Completed | No outcome recorded |
| Phase 3 | NCT00128661 Comparator | Jun 2004 → Dec 2010 | cervical cancer, precancerous condition | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00122681 Comparator | May 2004 → Nov 2006 | human papilloma virus infection | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00224484 Comparator | Apr 2004 → Jul 2007 | herpes simplex infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT02583412 Comparator | Sep 2015 → Sep 2016 | meningococcal infection | Canadian Immunization Research Network | Completed | No outcome recorded |
| Phase 4 | NCT01349829 Comparator | Mar 2010 → Apr 2011 | hepatitis A virus infection | Crucell Holland BV | 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 | NCT00534885 Comparator | Mar 2006 → Oct 2017 | hepatitis A virus infection | Sinovac Biotech Co., Ltd | 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 · 2
| Date | Issuer | Release |
|---|---|---|
| 2020-03-30 | Sinovac Biotech Co., Ltd | Results 儿童接种孩尔来福 ® 后11年随访研究显示：甲肝灭活疫苗能至少提供30年的有效保护 sinovac.com ↗
与贺福立适®组相比，孩尔来福®组在儿童接种11年之后免疫原性更优。 |
| 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 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-03-30 | Sinovac Biotech Co., Ltd | 儿童接种孩尔来福 ® 后11年随访研究显示：甲肝灭活疫苗能至少提供30年的有效保护 sinovac.com ↗ |
| 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 7 cited values
Every value below carries the sentence it was read from. 45 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Havrix | “Participants were randomly assigned (1:1) to receive an HPV vaccine (Cervarix, GlaxoSmithKline, Rixensart, Belgium) or a control hepatitis A vaccine (modified preparation of...” PMID 21865087 ↗ Aug 201148“GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix™) Co-administered With Merck & Company, Inc. Measles-Mumps-Rubella Vaccine (M-M-RII) & Merck & Co Varicella Vaccine...” NCT00197015 ↗ “and Havrix™ (1440 EL.U) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.” NCT00289731 ↗ “Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.” NCT00197236 ↗ “The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2.” NCT01352793 ↗ “Havrix at 1440IU was administrated à weeks S0, S4 and S24” NCT00190242 ↗ “hepatitis A vaccine ( HAVRIX or EPAXAL)” NCT01360970 ↗ |
| Known as | GSK-208109 | “GSK Biologicals' Hepatitis A Vaccine (Havrix®) (GSK-208109)” NCT02082639 ↗ |
| Known as | HAV | “HAVRIX (Hepatitis A Vaccine; HAV) is produced by GSK and is a sterile suspension of inactivated virus for IM administration.” NCT03917654 ↗2“Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination” NCT00839254 ↗ “Biological: Havrix (HAV)” NCT01830855 ↗ |
| Known as | Havrix TM | “GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)” NCT00861380 ↗ |
| Known as | Hepatitis A vaccine | “Havrix™, GlaxoSmithKline (GSK) Biologicals' licensed Hepatitis A vaccine” NCT00057330 ↗ |
| Modality | Vaccine | “licensed Hepatitis A vaccine” NCT00057330 ↗ |
| Route | Intramuscular | “the vaccine was administered intramuscularly in the non-dominant deltoid” NCT00057330 ↗ |