Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries

Study Description

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Brief Summary:

The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic

Condition or disease	Intervention/treatment	Phase
Encephalitis	Biological: IC51	Phase 3

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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 ]
2. 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 ]
3. 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 ]
4. Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination [ Time Frame: up to Day 56 and up to Month 7 ]
5. 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 ]
6. GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7 [ Time Frame: at Day 56 and Month 7 ]
7. SCRs and GMTs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups [ Time Frame: at Day 56 and Month 7 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	2 Months to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Valneva Austria GmbH

Investigators

Study Chair:	Andrea Ayad, Dr.	Valneva Austria GmbH

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Valneva Austria GmbH
ClinicalTrials.gov Identifier:	NCT01047839 History of Changes
Other Study ID Numbers:	IC51-322
First Posted:	January 13, 2010
Results First Posted:	December 19, 2014
Last Update Posted:	December 19, 2014
Last Verified:	September 2014

Keywords provided by Valneva Austria GmbH:

Pediatric; Japanese Encephalitis Vaccine; non-endemic countries; to assess immunogenicity of purified inactivated Japanese Encephalitis (JE) vaccine IC51

Additional relevant MeSH terms:

Encephalitis; Encephalitis, Japanese; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Encephalitis, Arbovirus; Arbovirus Infections; Virus Diseases; Encephalitis, Viral	Central Nervous System Viral Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Infectious Encephalitis; Central Nervous System Infections; Vaccines; Immunologic Factors; Physiological Effects of Drugs