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Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries

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ClinicalTrials.gov Identifier: NCT01047839
Recruitment Status : Completed
First Posted : January 13, 2010
Results First Posted : December 19, 2014
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH

Tracking Information
First Submitted Date  ICMJE January 12, 2010
First Posted Date  ICMJE January 13, 2010
Results First Submitted Date  ICMJE September 25, 2014
Results First Posted Date  ICMJE December 19, 2014
Last Update Posted Date June 30, 2020
Study Start Date  ICMJE January 2010
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2014)
Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination [ Time Frame: until Day 56 ]
Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2010)
SCRs as defined by percentage of subjects with PRNT50 titers of > 1:10 at day 56 and GMTs for JEV neutralizing antibodies measured using PRNT at Day 56 [ Time Frame: until Day 56 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2020)
  • Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination [ Time Frame: up to Month 7 ]
  • Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination [ Time Frame: 7 days ]
  • Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination [ Time Frame: up to Day 56 and upt to Month 7 ]
  • Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination [ Time Frame: up to Month 7 ]
    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.
  • 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) [ Time Frame: at Day 56 and Month 7 ]
  • GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7 [ Time Frame: at Day 56 and Month 7 ]
  • SCRs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups [ Time Frame: at Day 56 and Month 7 ]
  • GMTs at Day 56 and Month 7 Stratified According to Age Groups [ Time Frame: at Day 56 and Month 7 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2010)
  • SCRs and GMTs at Day 56 and Month 7 stratified according to dose groups, age groups, TBE vaccination history, travel to JE endemic areas, travel to JE endemic areas before Day 56, as well as travel to JE endemic areas after Day 56. [ Time Frame: at Day 56 and Month 7 ]
  • Rate of subjects with SAEs and medically attended AEs up to Day 56 and up to Month 7 after the first vaccination [ Time Frame: until Day 56 and up to Month 7 ]
  • Rate of subjects with solicited local and systemic AEs assessed with a subject diary for 7 consecutive days after each vaccination. [ Time Frame: study duration ]
  • Rate of subjects with unsolicited AEs up to Day 56 and up to Month 7 after the first vaccination. [ Time Frame: study duration ]
  • Rate of subjects with abnormal laboratory parameters (hematology, serum chemistry, urinalysis) up to Day 56 and up to Month 7 after the first vaccination. [ Time Frame: until Day 56 and up to Month 7 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries
Official Title  ICMJE 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
Brief Summary The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Encephalitis
Intervention  ICMJE
  • Biological: IC51
    0.25 ml, 2 i.m. vaccinations at Day 0 and 28
  • Biological: IC51
    0.5 ml, 2 i.m. vaccinations at Day 0 and 28
Study Arms  ICMJE
  • Experimental: >=2 months to <3 years
    IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and 28
    Intervention: Biological: IC51
  • Experimental: >=3 to <12 years
    IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
    Intervention: Biological: IC51
  • Experimental: >=12 to <18 years
    IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
    Intervention: Biological: IC51
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2010)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Denmark,   Germany,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01047839
Other Study ID Numbers  ICMJE IC51-322
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Valneva Austria GmbH
Study Sponsor  ICMJE Valneva Austria GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Andrea Ayad, Dr. Valneva Austria GmbH
PRS Account Valneva Austria GmbH
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP