Skip to main content
OpenTrials
Completed

NCT Number: NCT01047839

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Encephalitis Brain Diseases Central Nervous System Diseases Nervous System Diseases Neuroinflammatory Diseases

Age range

2 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dr. Deb - The Travel Doctor, Brisbane, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IC51

Biological

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

Primary outcomes

  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 outcomes

  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 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.

  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 at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups

    Time frame: at Day 56 and Month 7

  8. GMTs at Day 56 and Month 7 Stratified According to Age Groups

    Time frame: at Day 56 and Month 7

Sponsors and collaborators

Lead sponsor

Valneva Austria GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 13, 2010
Registry last updated
Jun 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.