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 14 · a red edge is where a trial was stopped
| 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| Phase 1 | NCT01559831 | Jun → Dec 2012 | Japanese encephalitis | Valneva Austria GmbH | Withdrawn | No outcome recorded |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 | ||||||
| Phase 2 | NCT05568953 | Sep 2022 → Oct 2025 | Japanese encephalitis, yellow fever | Singapore General Hospital | Unknown | No outcome recorded |
| 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 | NCT00605085 | Oct 2005 → Nov 2006 | Japanese 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 | NCT00604708 | Sep 2005 → Sep 2006 | Japanese encephalitis | Valneva Austria GmbH | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT06825312 | Nov 2023 → Dec 2030 expected | Japanese encephalitis | Liaoning Chengda Biotechnology CO., LTD | Active not recruiting | No outcome recorded |
| Phase 4 | NCT02532569 | Aug 2015 → Oct 2016 | Japanese encephalitis | Boryung Pharmaceutical Co., Ltd | Completed | 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 |
Also used as a comparator or background therapy in 14 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| 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 1/21 trial | ||||||
| Phase 1/2 | NCT06680128 Comparator | Feb 2025 → Jun 2026 overdue | Japanese encephalitis | SK Bioscience Co., Ltd. | Recruiting | No outcome recorded |
| Phase 311 trials | ||||||
| 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 | No outcome recorded |
| 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 | NCT00595465 Comparator | Dec 2007 → Feb 2008 | Japanese encephalitis | Valneva Austria GmbH | Completed | No outcome recorded |
| Phase 3 | NCT00595309 Comparator | Dec 2007 → Oct 2009 | 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 41 trial | ||||||
| Phase 4 | NCT03971058 Comparator | Mar 2019 → Dec 2020 | Japanese encephalitis | Medical University of Vienna | Unknown | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 30 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 | Boryung Cell Culture Japanese Encephalitis Vaccine | “All subjects were subcutaneously vaccinated once for the booster immunization with Boryung Cell Culture Japanese Encephalitis Vaccine® (JE-VC).” PMID 29429815 ↗ Mar 2018 |
| 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 | “All subjects were subcutaneously vaccinated once for the booster immunization with Boryung Cell Culture Japanese Encephalitis Vaccine® (JE-VC).” PMID 29429815 ↗ Mar 20181“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 ↗ |