Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT01246479
First received: October 6, 2010
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

The study investigates long-term immunity and safety of IC51 (IXIARO®, JESPECT®) in a pediatric population vaccinated in the parent study IC51-322.


Condition Intervention Phase
Japanese Encephalitis
Procedure: Blood draw
Biological: IC51 has given in the parent study IC51-322
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Long Term Immunity and Safety Following Vaccination With the Japanese Encephalitis Vaccine IC51(IXIARO®, JESPECT®) In a Pediatric Population in Non Endemic Countries. Uncontrolled, Phase 3 Follow-up Study

Resource links provided by NLM:


Further study details as provided by Valneva Austria GmbH:

Primary Outcome Measures:
  • Rate of subjects with PRNT50 titers of ≥ 1:10 at Month 12 after the first IC51 vaccination (in study IC51-322) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Rate of subjects with PRNT50 titers of ≥ 1:10 at Month 12 after the first IC51 vaccination (in study IC51-322)


Secondary Outcome Measures:
  • GMT for JEV neutralizing antibodies measured using the PRNT at Month 12 after the first IC51 vaccination (in study IC51-322) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    GMT for JEV neutralizing antibodies measured using the PRNT at Month 12 after the first IC51 vaccination (in study IC51-322)

  • GMTs and rate of subjects with PRNT50 titers of ≥ 1:10 at Months 24 and 36 after the first IC51 vaccination (in study IC51-322) [ Time Frame: Month 24, 36 ] [ Designated as safety issue: No ]
    GMTs and rate of subjects with PRNT50 titers of ≥ 1:10 at Months 24 and 36 after the first IC51 vaccination (in study IC51-322)

  • Rate of subjects with SAEs following immunization up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322) [ Time Frame: Months 12, 24 and 36 ] [ Designated as safety issue: Yes ]
    Rate of subjects with SAEs following immunization up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322)

  • Rate of subjects with AEs and medically attended AEs up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322). Severity, duration and relationship to vaccinations. [ Time Frame: Months 12, 24 and 36 ] [ Designated as safety issue: Yes ]
    Rate of subjects with AEs and medically attended AEs up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322). Severity, duration and relationship to vaccinations.


Enrollment: 23
Study Start Date: October 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No treatment
subjects will be followed up on immunity (analysis of blood samples) and safety
Procedure: Blood draw
blood draw at Month 12, Month 24 and Month 36.
Biological: IC51 has given in the parent study IC51-322
No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.

  Eligibility

Ages Eligible for Study:   9 Months to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who have received two vaccinations in study IC51 322. (2) Subjects who were enrolled as part of the immunogenicity subgroup of study IC51‐322.
  • Male or female healthy subjects aged ≥ 9 months to < 21 years at the time of enrolment into this study.
  • Written informed consent by the subject, the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable.

Exclusion Criteria:

  • History of or clinical manifestation of any Flavivirus disease during study IC51‐322.
  • Vaccination against JE virus (JEV) (except with IC51) at any time prior or planned during this study.
  • Participation in another study with an investigational product during study IC51‐322 or IC51‐324.
  • History of or development of any immunodeficiency including post‐organtransplantation after inclusion into study IC51‐322.
  • History of or development of an autoimmune disease during study IC51‐322.
  • Administration of chronic (defined as more than 14 days) immunosuppressants or other immune‐modifying medications started during study IC51‐322 up to first visit of study IC51‐324. (For corticosteroids this means prednisone or equivalent at >= 0.05 mg/kg/day. Topical or inhaled steroids are allowed).
  • Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
  • Illicit drug use and/or a history of drug or alcohol addiction and/or current drug or alcohol addiction.
  • Inability or unwillingness by the legal representative(s) and/or the subject (where applicable) to provide informed consent/assent and to abide by the requirements of the study.
  • Persons who are committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246479

Locations
United States, Florida
Tampa, Florida, United States
Australia
Bisbane, Australia
Melbourne, Australia
Germany
Berlin, Germany
Hamburg, Germany
Sponsors and Collaborators
Valneva Austria GmbH
Investigators
Study Chair: Andrea Ayad, Dr. Valneva Austria GmbH
  More Information

No publications provided

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT01246479     History of Changes
Other Study ID Numbers: IC51-324
Study First Received: October 6, 2010
Last Updated: December 5, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 23, 2014