Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries
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ClinicalTrials.gov Identifier: NCT01047839 |
Recruitment Status :
Completed
First Posted : January 13, 2010
Results First Posted : December 19, 2014
Last Update Posted : June 30, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Encephalitis | Biological: IC51 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries. Uncontrolled, Open-label Phase 3 Study |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | August 2013 |
Actual Study Completion Date : | August 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: >=2 months to <3 years
IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and 28
|
Biological: IC51
0.25 ml, 2 i.m. vaccinations at Day 0 and 28 |
Experimental: >=3 to <12 years
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
Biological: IC51
0.5 ml, 2 i.m. vaccinations at Day 0 and 28 |
Experimental: >=12 to <18 years
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
|
Biological: IC51
0.5 ml, 2 i.m. vaccinations at Day 0 and 28 |
- Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination [ Time Frame: until Day 56 ]Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.
- Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination [ Time Frame: up to Month 7 ]
- Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination [ Time Frame: 7 days ]
- Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination [ Time Frame: up to Day 56 and upt to Month 7 ]
- Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination [ Time Frame: up to Month 7 ]Laboratory parameters were assessed at the Day 28, Day 56 and Month 7 visit. Endpoint reflects abnormal laboratory parameters assessed as clinically significant by the investigator.
- SCRs as Defined as Percentage of Subjects With JEV Neutralizing Antibody Titers of PRNT 50 >= 1:10 at Day 56 and Month 7, Measured Using a Validated Plaque Reduction Neutralization Test (PRNT) [ Time Frame: at Day 56 and Month 7 ]
- GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7 [ Time Frame: at Day 56 and Month 7 ]
- SCRs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups [ Time Frame: at Day 56 and Month 7 ]
- GMTs at Day 56 and Month 7 Stratified According to Age Groups [ Time Frame: at Day 56 and Month 7 ]

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Ages Eligible for Study: | 2 Months to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male or female healthy children and adolescents aged >=2 months to <18 years at the time of first vaccination
- Written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable
- Female subjects: either no childbearing potential or negative pregnancy test. For females after menarche willingness to practice a reliable method of contraception.
- The subject is planning to travel to an area where JE is endemic after completion of the vaccination schedule. Exposure to JE should be avoided until 1 week after the second IC51 dose and subjects should return from travel to JE endemic areas before the Month 7 visit. The planned travel to JE endemic areas should not interfere with the study visits and can take place between Visit 2 + 7 days to Month 7.
Exclusion Criteria:
- Clinical manifestation or history of any Flavivirus disease
- Vaccination against JE (except within this protocol), Yellow fever, West Nile virus and Dengue at any time prior or during the study
- History of immunodeficiency or immunosuppressive therapy
- Known HIV, HBV or HCV infection
- History of hypersensitivity reactions to other vaccines
- Acute febrile infection at each visit during which the subject receives a vaccination
- Active or passive immunization within 1 week before and 1 week after each IC51 vaccination.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01047839
United States, Florida | |
Tampa Clinical Research Inc. | |
Tampa, Florida, United States, 33624 | |
United States, Maryland | |
Passport Health | |
Baltimore, Maryland, United States, 21230 | |
United States, Massachusetts | |
Boston Medical Center | |
Boston, Massachusetts, United States, 02118 | |
United States, New York | |
Bronx Lebanon Hospital Center | |
New York, New York, United States, 10457 | |
Australia, Queensland | |
Dr. Deb - The Travel Doctor | |
Brisbane, Queensland, Australia, 4001 | |
Australia, Victoria | |
Travel Doctor - TMVC Australia | |
Melbourne, Victoria, Australia, 3000 | |
Denmark | |
Danske Laegers Forsknings Center | |
Soborg, Denmark, 2860 | |
Germany | |
Berliner Zentrum für Reise- und Tropenmedizin | |
Berlin, Germany, 10117 | |
Universitätsklinikum Hamburg-Eppendorf | |
Hamburg, Germany, 20246 | |
Sweden | |
City Akuten Wasa Vaccination | |
Stockholm, Sweden, 11136 |
Study Chair: | Andrea Ayad, Dr. | Valneva Austria GmbH |
Responsible Party: | Valneva Austria GmbH |
ClinicalTrials.gov Identifier: | NCT01047839 |
Other Study ID Numbers: |
IC51-322 |
First Posted: | January 13, 2010 Key Record Dates |
Results First Posted: | December 19, 2014 |
Last Update Posted: | June 30, 2020 |
Last Verified: | June 2020 |
Pediatric Japanese Encephalitis Vaccine non-endemic countries to assess immunogenicity of purified inactivated Japanese Encephalitis (JE) vaccine IC51 |
Encephalitis, Japanese Encephalitis Brain Diseases Central Nervous System Diseases Nervous System Diseases Encephalitis, Arbovirus Encephalitis, Viral Central Nervous System Viral Diseases Central Nervous System Infections |
Infections Infectious Encephalitis Arbovirus Infections Vector Borne Diseases Virus Diseases RNA Virus Infections Flavivirus Infections Flaviviridae Infections |