Clinical Trial: Open-label, Randomized Study in a Pediatric Population in a JEV (Japanese Encephalitis Virus)-Endemic Country

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Long-Term Immunity and Safety With or Without a Booster Dose Following Primary Vaccination With the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Popula

Brief Summary: This is a randomized, open-label Phase 3 study including children aged >9 months to <17 years and 7 months who have been vaccinated with IXIARO in study IC51-323.

Detailed Summary: This is a randomized, open-label Phase 3 study including children aged >9 months to <17 years and 7 months who have been vaccinated with IXIARO in the previous study IC51-323.
Sponsor: Valneva Austria GmbH

Current Primary Outcome: SCRs (Seroconversion Rate) as Defined by Percentage of Subjects With Plaque Reduction Neutralization Test Titers of>1:10 at 1 Month After the Booster Dose [ Time Frame: 1 month post booster ]

Original Primary Outcome: SCRs as defined by percentage of subjects with plaque reduction neutralization test titers of>1:10 at 1 month after the booster dose [ Time Frame: 1 month ]

Current Secondary Outcome:

  • Rate of Subjects Achieving a >4-fold Increase in JEV (Japanese Encephalitis Virus) Neutralizing Antibody Titers at 1 Month After the Booster Dose [ Time Frame: 1 month ]
  • GMTs (Geometric Mean Titre) for JEV Neutralizing Antibodies Measured Using a Validated PRNT (Plaque Reduction Neutralization Test) at 1 Month After the Booster Dose [ Time Frame: 1 month ]
  • GMTs and Rate of Subjects With a PRNT Titer of >1:10 at Months 12, 24 and 36 After First IXIARO Vaccination in IC51-323 With and Without Booster Vaccination [ Time Frame: 36 months ]
  • Rate of Subjects With SAEs (Serious Adverse Events) Following Immunization and Medically Attended AEs (Adverse Events) up to Months 12, 24 and 36 After the First IXIARO Vaccination in IC51 323 With and Without Booster Vaccination. Severity, Duration and [ Time Frame: 36 months ]
  • Rate of Subjects With Unsolicited AEs (Adverse Events) up to Months 12, 24 and 36 After the First IXIARO Vaccination in IC51 323 With and Without Booster Vaccination. Severity, Duration and Relationship to Vaccinations. [ Time Frame: 36 months ]
  • Rate of Subjects With SAEs and Medically Attended AEs Within 1 Month Following the Booster Dose. Severity, Duration and Relationship to Vaccinations. [ Time Frame: 1 month ]
  • Rate of Subjects With Unsolicited AEs Within 1 Month Following the Booster Dose. Severity, Duration and Relationship to Vaccinations. [ Time Frame: 1 month ]
  • Rate of Subjects With Solicited AEs for up to 7 Days Following the Booster Dose. Severity and Duration. [ Time Frame: 7 days ]


Original Secondary Outcome:

  • Rate of subjects achieving a >4-fold increase in JEV neutralizing antibody titers at 1 month after the booster dose [ Time Frame: 1 month ]
  • GMTs for JEV neutralizing antibodies measured using a validated PRNT at 1 month after the booster dose [ Time Frame: 1 month ]
  • GMTs and reate of subjects with a PRNT titer of >1:10 at Months 12, 24 and 36 after first IXIARO vaccination in IC51-323 with and without booster vaccination [ Time Frame: 36 months ]
  • Rate of subjects with SAEs following immunization and medically attended AEs up to Months 12, 24 and 36 after the first IXIARO vaccination in IC51 323 with and without booster vaccination. Severity, duration and [ Time Frame: 36 months ]
  • Rate of subjects with unsolicited AEs up to Months 12, 24 and 36 after the first IXIARO vaccination in IC51 323 with and without booster vaccination. Severity, duration and relationship to vaccinations. [ Time Frame: 36 months ]
  • Rate of Subjects With SAEs and Medically Attended AEs Within 1 Month Following the Booster Dose. Severity, Duration and Relationship to Vaccinations. [ Time Frame: 1 month ]
  • Rate of Subjects With Unsolicited AEs Within 1 Month Following the Booster Dose. Severity, Duration and Relationship to Vaccinations. [ Time Frame: 1 month ]
  • Rate of Subjects With Solicited AEs for up to 7 Days Following the Booster Dose. Severity and Duration. [ Time Frame: 7 days ]


Information By: Valneva Austria GmbH

Dates:
Date Received: December 28, 2010
Date Started: December 2010
Date Completion:
Last Updated: December 10, 2014
Last Verified: December 2014