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

Encephalitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047839
• Other study ID #: IC51-322
• Status: Completed
• Phase: Phase 3
• Start date: January 2010
• Est. completion date: August 2013

Study information

• Verified date: June 2020
• Source: Valneva Austria GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese

Intervention

Biological:
• IC51
0.25 ml, 2 i.m. vaccinations at Day 0 and 28
• IC51
0.5 ml, 2 i.m. vaccinations at Day 0 and 28
• IC51
0.5 ml, 2 i.m. vaccinations at Day 0 and 28

Locations

Country	Name	City	State
Australia	Dr. Deb - The Travel Doctor	Brisbane	Queensland
Australia	Travel Doctor - TMVC Australia	Melbourne	Victoria
Denmark	Danske Laegers Forsknings Center	Soborg
Germany	Berliner Zentrum für Reise- und Tropenmedizin	Berlin
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Sweden	City Akuten Wasa Vaccination	Stockholm
United States	Passport Health	Baltimore	Maryland
United States	Boston Medical Center	Boston	Massachusetts
United States	Bronx Lebanon Hospital Center	New York	New York
United States	Tampa Clinical Research Inc.	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Valneva Austria GmbH

Countries where clinical trial is conducted

United States,  Australia,  Denmark,  Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 Day 56 after the first vaccination.	until Day 56
Secondary	Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination		up to Month 7
Secondary	Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination		7 days
Secondary	Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination		up to Day 56 and upt to Month 7
Secondary	Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination	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.	up to Month 7
Secondary	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)		at Day 56 and Month 7
Secondary	GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7		at Day 56 and Month 7
Secondary	SCRs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups		at Day 56 and Month 7
Secondary	GMTs at Day 56 and Month 7 Stratified According to Age Groups		at Day 56 and Month 7