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

• 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: Valneva Austria GmbH
• Information provided by (Responsible Party): Valneva Austria GmbH

Tracking Information

• First Submitted Date: January 12, 2010
• First Posted Date: January 13, 2010
• Results First Submitted Date: September 25, 2014
• Results First Posted Date: December 19, 2014
• Last Update Posted Date: June 30, 2020
• Study Start Date: January 2010
• Actual Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries
• Official 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Encephalitis

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 12, 2010): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 2013
• Actual Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 2 Months to 17 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Denmark, Germany, Sweden, United States

Administrative Information

• NCT Number: NCT01047839
• Other Study ID Numbers: IC51-322
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Valneva Austria GmbH
• Study Sponsor: Valneva Austria GmbH
• Collaborators: Not Provided

Investigators

• Study Chair: Andrea Ayad, Dr.; Valneva Austria GmbH

• PRS Account: Valneva Austria GmbH
• Verification Date: June 2020