Drugs / IC51
IC51
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Ixiaro | — | 2009-03-31 | europa.eu ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01559831 | Jun → Dec 2012 | Japanese encephalitis | Valneva Austria GmbH | Withdrawn | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT05568953 | Sep 2022 → Oct 2025 | Japanese encephalitis, yellow fever | Singapore General Hospital | Unknown | Met primary |
| Phase 2 | NCT01943825 | Nov 2013 → Nov 2015 | Dengue hemorrhagic fever | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 2 | NCT01943305 | Oct 2013 → Jun 2015 | Japanese encephalitis, yellow fever | Singapore General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00694460 | Aug 2002 → Aug 2004 | Japanese encephalitis, rabies | Novartis | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT01041573 | Mar 2010 → Feb 2011 | encephalitis | Valneva Austria GmbH | Completed | No outcome recorded |
| Phase 3 | NCT01047839 | Jan 2010 → Aug 2013 | encephalitis | Valneva Austria GmbH | Completed | No outcome recorded |
| Phase 3 | NCT00595270 | Oct 2005 → Sep 2007 | Japanese encephalitis | Valneva Austria GmbH | Completed | No outcome recorded |
| Phase 3 | NCT00605085 | Oct 2005 → Nov 2006 | Japanese encephalitis | Valneva Austria GmbH | Completed | No outcome recorded |
| Phase 3 | NCT00604708 | Sep 2005 → Sep 2006 | Japanese encephalitis | Valneva Austria GmbH | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT06825312 | Nov 2023 → Dec 2030 expected | Japanese encephalitis | Liaoning Chengda Biotechnology CO., LTD | Active not recruiting | No outcome recorded |
| Phase 4 | NCT01398540 | Nov 2010 → Oct 2012 | — | Medical University of Vienna | Completed | No outcome recorded |
| Phase 4 | NCT01158599 | Jun 2010 → Jun 2011 | Japanese encephalitis | Valneva Austria GmbH | Completed | No outcome recorded |
| Comparator or background therapy14 trials | ||||||
| Phase 1 | NCT02963909 Background | Nov 2016 → Oct 2018 | Zika virus infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/2 | NCT06680128 Comparator | Feb 2025 → Jul 2026 | Japanese encephalitis | SK Bioscience Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01466387 Comparator | Nov 2011 → Apr 2012 | Japanese encephalitis, meningococcal meningitis, rabies, typhoid fever +1 | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT01296360 Comparator | Dec 2010 → Nov 2011 | Japanese encephalitis | Valneva Austria GmbH | Completed | No outcome recorded |
| Phase 3 | NCT01246479 Background | Oct 2010 → Oct 2012 | Japanese encephalitis | Valneva Austria GmbH | Completed | No outcome recorded |
| Phase 3 | NCT01214850 Comparator | Sep 2010 → Jan 2012 | meningococcal infection | Novartis Vaccines | Completed | Missed primary |
| Phase 3 | NCT00776230 Comparator | Sep 2008 → Jun 2010 | Japanese encephalitis | Valneva Austria GmbH | Completed | No outcome recorded |
| Phase 3 | NCT01386827 Comparator | Jan 2008 → Apr 2011 | Japanese encephalitis | Helsinki University Central Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00595309 Comparator | Dec 2007 → Oct 2009 | Japanese encephalitis | Valneva Austria GmbH | Completed | No outcome recorded |
| Phase 3 | NCT00595465 Comparator | Dec 2007 → Feb 2008 | Japanese encephalitis | Valneva Austria GmbH | Completed | No outcome recorded |
| Phase 3 | NCT00594958 Comparator | Sep 2006 → Apr 2007 | Japanese encephalitis | Valneva Austria GmbH | Completed | No outcome recorded |
| Phase 3 | NCT00595790 Comparator | Sep 2005 → Feb 2006 | Japanese encephalitis | Valneva Austria GmbH | Completed | No outcome recorded |
| Phase 3 | NCT00596271 Comparator | Sep 2005 → Jul 2006 | Japanese encephalitis | Valneva Austria GmbH | Completed | No outcome recorded |
| Phase 4 | NCT03971058 Comparator | Mar 2019 → Dec 2020 | Japanese encephalitis | Medical University of Vienna | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2020-03-08 | Valneva Austria GmbH | Regulatory Valneva Announces FDA Approval of IXIARO® Shelf Life Extension to 36 Months; New US Military RFP Issued valneva.com ↗
Valneva SE (“Valneva” or “the Company”), today announced that the Food and Drug Administration (FDA) has approved the extension of the shelf life of its Japanese encephalitis vaccine IXIARO® from 24 months to 36 months. |
| 2019-11-28 | Valneva Austria GmbH | Regulatory Valneva Announces EMA Approval of IXIARO® Shelf Life Extension to 36 Months valneva.com ↗
Valneva SE (“Valneva” or “the Company”), today announced that the European Medicines Agency (EMA) has approved the extension of the shelf life of its Japanese encephalitis vaccine IXIARO® from 24 months to 36 months. |
| 2018-10-05 | Valneva Austria GmbH | Regulatory Valneva Announces FDA Approval of Accelerated IXIARO® Vaccination Schedule valneva.com ↗
Valneva SE (“Valneva” or “the Company”), a commercial stage biotech company focused on developing innovative lifesaving vaccin es, announced today that the U.S. Food and Drug Administration (FDA) has approved an alternate IXIARO® immunization schedule of two doses administered seven days apart for adult travelers aged 18-65 years old. |
| 2016-01-11 | Valneva Austria GmbH | Regulatory Valneva Announces Approval of its Japanese Encephalitis Vaccine through Commercial Partner Adimmune in Taiwan valneva.com ↗ |
| 2013-10-18 | Valneva Austria GmbH | Regulatory Valneva Wins FDA Market Exclusivity for the Pediatric Indication of IXIARO® in the United States valneva.com ↗
Valneva SE (Valneva) today announced that the U.S. FDA’s Office of Orphan Drug Development (OOPD) granted a 7 years orphan drug market exclusivity period for IXIARO® for prevention of disease caused by Japanese encephalitis virus in children 2 months to less than 17 years of age. |
| 2013-06-21 | Valneva Austria GmbH | Regulatory ACIP Unanimously Votes to Extend the Recommendations for Use of IXIARO®Vaccine valneva.com ↗
Valneva SE today announced that the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) approved by unanimous vote on June 19, 2013 to extend the current JE vaccination recommendations for use of IXIARO ® to include travelling individuals aged 2 months and above. |
| 2013-05-21 | Valneva Austria GmbH | Regulatory Intercell Announces Pediatric Approval of its Japanese Encephalitis Vaccine in the U.S. valneva.com ↗
Intercell AG (VSE; “ICLL”) announced today that the pediatric indication for IXIARO®, a vaccine to protect against Japanese Encephalitis (JE), was approved by the U.S. Food and Drug Administration (FDA). |
| 2013-02-12 | Valneva Austria GmbH | Regulatory Intercell announces pediatric approval of its Japanese Encephalitis vaccine in Europe valneva.com ↗ |
All press releases naming this drug 23 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 29 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IC51 | “Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51” NCT00595465 ↗13“Japanese Encephalitis (JE) Vaccine Ixiaro® (IC51)” NCT01158599 ↗ “Japanese Encephalitis Vaccine IC51 (IXIARO®)” NCT01296360 ↗ |
| Known as | IXIARO | “Participants will receive 2 doses of one of the active comparators (IXIARO®, 6 Antigen Unit, corresponding to a potency of ≤ 460 ng ED) at 4-week intervals, respectively in...” NCT06680128 ↗15“INTRODUCTION: IXIARO (IC51), a recently approved inactivated Japanese Encephalitis vaccine, is immunogenic and safe in a 0/28 days primary immunization schedule.” PMID 21288804 ↗ Feb 2011 “The study investigates long-term immunity and safety of IC51 (IXIARO®, JESPECT®) in a pediatric population vaccinated in the parent study IC51-322.” NCT01246479 ↗ “Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries” NCT01047839 ↗ “IXIARO, inactivated, adsorbed vaccine. Two doses (0.5 ml each) of IXIARO one month apart” NCT01943305 ↗ “Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population” NCT01041573 ↗ “two-dose regimen of IXIARO® (Valneva) 28 days apart” NCT02963909 ↗ |
| Known as | Japanese Encephalitis purified inactivated vaccine | “Japanese Encephalitis purified inactivated vaccine (IC51)” NCT00605085 ↗ |
| Known as | Japanese Encephalitis Vaccine | “Vaccination with Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL only subcutaneously on Day 0 and Day 7 (a total of 2 doses)” NCT00694460 ↗ |
| Known as | Japanese Encephalitis Vaccine, Live | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06825312 ↗ |
| Known as | JE-PIV | “IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28” NCT00605085 ↗2“IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28” NCT00604708 ↗ “Japanese Encephalitis vaccine IC51 (JE-PIV)” NCT00596271 ↗ |
| Known as | JE-VC | “Vero cell-derived vaccine (JE-VC; Ixiaro) has replaced traditional mouse brain-derived vaccines (JE-MB) associated with safety concerns.” PMID 22696017 ↗ Jun 2012 |
| Known as | JESPECT | “The study investigates long-term immunity and safety of IC51 (IXIARO®, JESPECT®) in a pediatric population vaccinated in the parent study IC51-322.” NCT01246479 ↗1“Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries” NCT01047839 ↗ |
| Modality | Vaccine | “Japanese Encephalitis Vaccine IC51” NCT00594958 ↗ |
| Route | Intramuscular | “6 mcg, intramuscularly” NCT00594958 ↗ |