Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01246479




Registration number
NCT01246479
Ethics application status
Date submitted
6/10/2010
Date registered
23/11/2010
Date last updated
18/03/2020

Titles & IDs
Public title
Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study
Scientific 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
Secondary ID [1] 0 0
IC51-324
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Japanese Encephalitis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Blood draw
Other interventions - IC51 has given in the parent study IC51-322

Other: No treatment - subjects will be followed up on immunity (analysis of blood samples) and safety


Treatment: Surgery: Blood draw
blood draw at Month 12, Month 24 and Month 36.

Other interventions: 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.
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of Subjects With PRNT50 Titers of = 1:10 at Month 12 After the First IC51 Vaccination (in Study IC51-322)
Timepoint [1] 0 0
Month 12
Secondary outcome [1] 0 0
GMT for JEV Neutralizing Antibodies Measured Using the PRNT at Month 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322)
Timepoint [1] 0 0
Month 12, 24 and 36
Secondary outcome [2] 0 0
Rate of Subjects With PRNT50 Titers of = 1:10 at Months 24 and 36 After the First IC51 Vaccination (in Study IC51-322)
Timepoint [2] 0 0
Month 24, 36
Secondary outcome [3] 0 0
Rate of Subjects With SAEs Following Immunization up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322)
Timepoint [3] 0 0
Months 12, 24 and 36
Secondary outcome [4] 0 0
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).
Timepoint [4] 0 0
Months 12, 24 and 36

Eligibility
Key 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.
Minimum age
9 Months
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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).

Study design
Purpose of the study
Other
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2014
Sample size
Target
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Brisbane
Recruitment hospital [2] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
Germany
State/province [2] 0 0
Berlin
Country [3] 0 0
Germany
State/province [3] 0 0
Hamburg

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Valneva Austria GmbH
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01246479
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrea Ayad, Dr.
Address 0 0
Valneva Austria GmbH
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01246479