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

Japanese Encephalitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01246479
• Other study ID #: IC51-324
• Status: Completed
• Phase: Phase 3
• Start date: October 2010
• Est. completion date: September 2014

Study information

• Verified date: March 2020
• Source: Valneva Austria GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2014
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Months to 20 Years

Eligibility

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).

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Valneva Austria GmbH

Countries where clinical trial is conducted

United States,  Australia,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Subjects With PRNT50 Titers of = 1:10 at Month 12 After the First IC51 Vaccination (in Study IC51-322)	Rate of subjects with PRNT50 titers of = 1:10 at Month 12 after the first IC51 vaccination (in study IC51-322)	Month 12
Secondary	GMT for JEV Neutralizing Antibodies Measured Using the PRNT at Month 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322)	GMT for JEV neutralizing antibodies measured using the PRNT at Month 12, 24 and 36 after the first IC51 vaccination (in study IC51-322)	Month 12, 24 and 36
Secondary	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 PRNT50 titers of = 1:10 at Months 24 and 36 after the first IC51 vaccination (in study IC51-322)	Month 24, 36
Secondary	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 SAEs following immunization up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322)	Months 12, 24 and 36
Secondary	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).	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).	Months 12, 24 and 36