COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

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/show/NCT01047839




Registration number
NCT01047839
Ethics application status
Date submitted
12/01/2010
Date registered
13/01/2010
Date last updated
30/06/2020

Titles & IDs
Public title
Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries
Scientific title
Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries. Uncontrolled, Open-label Phase 3 Study
Secondary ID [1] 0 0
IC51-322
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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
Other interventions - IC51
Other interventions - IC51
Other interventions - IC51

Experimental: >=2 months to <3 years - IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and 28

Experimental: >=3 to <12 years - IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28

Experimental: >=12 to <18 years - IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28


Other interventions: IC51
0.25 ml, 2 i.m. vaccinations at Day 0 and 28

Other interventions: IC51
0.5 ml, 2 i.m. vaccinations at Day 0 and 28

Other interventions: IC51
0.5 ml, 2 i.m. vaccinations at Day 0 and 28

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination - Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.
Timepoint [1] 0 0
until Day 56
Secondary outcome [1] 0 0
Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination
Timepoint [1] 0 0
up to Month 7
Secondary outcome [2] 0 0
Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination
Timepoint [2] 0 0
7 days
Secondary outcome [3] 0 0
Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination
Timepoint [3] 0 0
up to Day 56 and upt to Month 7
Secondary outcome [4] 0 0
Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination - Laboratory parameters were assessed at the Day 28, Day 56 and Month 7 visit. Endpoint reflects abnormal laboratory parameters assessed as clinically significant by the investigator.
Timepoint [4] 0 0
up to Month 7
Secondary outcome [5] 0 0
SCRs as Defined as Percentage of Subjects With JEV Neutralizing Antibody Titers of PRNT 50 >= 1:10 at Day 56 and Month 7, Measured Using a Validated Plaque Reduction Neutralization Test (PRNT)
Timepoint [5] 0 0
at Day 56 and Month 7
Secondary outcome [6] 0 0
GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7
Timepoint [6] 0 0
at Day 56 and Month 7
Secondary outcome [7] 0 0
SCRs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups
Timepoint [7] 0 0
at Day 56 and Month 7
Secondary outcome [8] 0 0
GMTs at Day 56 and Month 7 Stratified According to Age Groups
Timepoint [8] 0 0
at Day 56 and Month 7

Eligibility
Key inclusion criteria
- Male or female healthy children and adolescents aged >=2 months to <18 years at the
time of first vaccination

- Written informed consent by the subject's legal representative(s), according to local
requirements, and written informed assent of the subject, if applicable

- Female subjects: either no childbearing potential or negative pregnancy test. For
females after menarche willingness to practice a reliable method of contraception.

- The subject is planning to travel to an area where JE is endemic after completion of
the vaccination schedule. Exposure to JE should be avoided until 1 week after the
second IC51 dose and subjects should return from travel to JE endemic areas before the
Month 7 visit. The planned travel to JE endemic areas should not interfere with the
study visits and can take place between Visit 2 + 7 days to Month 7.
Minimum age
2 Months
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Clinical manifestation or history of any Flavivirus disease

- Vaccination against JE (except within this protocol), Yellow fever, West Nile virus
and Dengue at any time prior or during the study

- History of immunodeficiency or immunosuppressive therapy

- Known HIV, HBV or HCV infection

- History of hypersensitivity reactions to other vaccines

- Acute febrile infection at each visit during which the subject receives a vaccination

- Active or passive immunization within 1 week before and 1 week after each IC51
vaccination.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
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
Parallel
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Dr. Deb - The Travel Doctor - Brisbane
Recruitment hospital [2] 0 0
Travel Doctor - TMVC Australia - Melbourne
Recruitment postcode(s) [1] 0 0
4001 - Brisbane
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
Denmark
State/province [5] 0 0
Soborg
Country [6] 0 0
Germany
State/province [6] 0 0
Berlin
Country [7] 0 0
Germany
State/province [7] 0 0
Hamburg
Country [8] 0 0
Sweden
State/province [8] 0 0
Stockholm

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

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective is to assess the safety profile of IC51 in a pediatric population from
regions where JEV is not endemic
Trial website
https://clinicaltrials.gov/show/NCT01047839
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
Other publications