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

NCT01047839 | Completed Phase 3 Results DMC

• 1 other identifier: IC51-322
• Study Type: interventional
• Target: 100
• Locations: 5 countries
• Sites: 10

Brief Summary

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

Conditions

Encephalitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination

  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

  7 days

• 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

• Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination

  up to Month 7

• 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

Study Arms (3)

>=2 months to <3 years

EXPERIMENTAL

IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and 28

Biological: IC51

>=3 to <12 years

EXPERIMENTAL

IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28

Biological: IC51

>=12 to <18 years

EXPERIMENTAL

IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28

Biological: IC51

Interventions

IC51 BIOLOGICAL

0.25 ml, 2 i.m. vaccinations at Day 0 and 28

>=2 months to <3 years

Eligibility Criteria

• Age: 2 Months - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Valneva Austria GmbH: lead

Study Sites (10)

Tampa Clinical Research Inc.

Tampa, Florida, 33624, United States

Location

Passport Health

Baltimore, Maryland, 21230, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Bronx Lebanon Hospital Center

New York, New York, 10457, United States

Location

Dr. Deb - The Travel Doctor

Brisbane, Queensland, 4001, Australia

Location

Travel Doctor - TMVC Australia

Melbourne, Victoria, 3000, Australia

Location

Danske Laegers Forsknings Center

Søborg, 2860, Denmark

Location

Berliner Zentrum für Reise- und Tropenmedizin

Berlin, 10117, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

City Akuten Wasa Vaccination

Stockholm, 11136, Sweden

Location

MeSH Terms

Conditions

Encephalitis

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Results Point of Contact

• Title: Senior Scientist Clinical Research
• Organization: Valneva Austria GmbH

katrin.dubischar-kastner@valneva.com

+43 1 206 20

Study Officials

• Andrea Ayad, Dr.

  Valneva Austria GmbH

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 13, 2010
• Study Start: January 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 30, 2020
• Results First Posted: December 19, 2014

Record last verified: 2020-06

Locations

AU (2); US (4); DE (2); DK (1); SE (1)