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

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ClinicalTrials.gov Identifier: NCT01246479
Recruitment Status : Completed
First Posted : November 23, 2010
Results First Posted : April 29, 2015
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH

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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Study Start Date : October 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Rate of subjects with PRNT50 titers of ≥ 1:10 at Month 12 after the first IC51 vaccination (in study IC51-322)


Secondary Outcome Measures :
  1. GMT for JEV Neutralizing Antibodies Measured Using the PRNT at Month 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322) [ Time Frame: Month 12, 24 and 36 ]
    GMT for JEV neutralizing antibodies measured using the PRNT at Month 12, 24 and 36 after the first IC51 vaccination (in study IC51-322)

  2. 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 ]
    Rate of subjects with PRNT50 titers of ≥ 1:10 at Months 24 and 36 after the first IC51 vaccination (in study IC51-322)

  3. 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 ]
    Rate of subjects with SAEs following immunization up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322)

  4. 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). [ Time Frame: Months 12, 24 and 36 ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   9 Months to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01246479


Locations
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United States, Florida
Tampa, Florida, United States
Australia
Brisbane, Australia
Melbourne, Australia
Germany
Berlin, Germany
Hamburg, Germany
Sponsors and Collaborators
Valneva Austria GmbH
Investigators
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Study Chair: Andrea Ayad, Dr. Valneva Austria GmbH
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT01246479    
Other Study ID Numbers: IC51-324
First Posted: November 23, 2010    Key Record Dates
Results First Posted: April 29, 2015
Last Update Posted: March 18, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Encephalitis, Japanese
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Central Nervous System Viral Diseases
Central Nervous System Infections
 Infections
Infectious Encephalitis
Arbovirus Infections
Vector Borne Diseases
Virus Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections