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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Treatment: Other - IC51
Treatment: Other - IC51
Treatment: Other - 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


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

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

Treatment: Other: IC51
0.5 ml, 2 i.m. vaccinations at Day 0 and 28
Intervention code [1] 0 0
Treatment: Other
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
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
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
Sex
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
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2013
Sample size
Target
Accrual to date
Final
100
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/study/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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01047839