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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT01047839
First received: January 12, 2010
Last updated: December 5, 2013
Last verified: December 2013

January 12, 2010
December 5, 2013
January 2010
August 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01047839 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Rate of subjects with abnormal laboratory parameters up to Day 56 and up to Month 7 after the first vaccination [ Time Frame: up to Day 56 and up to Month 7 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • GMTs for JEV neutralizing antibodies measured using a validated PRNT at Day 56 and Month 7 [ Time Frame: at Day 56 and Month 7 ] [ Designated as safety issue: Yes ]
  • SCRs and GMTs at Day 56 and Month 7 stratified according to dose gropus and age groups [ Time Frame: at Day 56 and Month 7 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Rate of subjects with unsolicited AEs up to Day 56 and up to Month 7 after the first vaccination. [ Time Frame: study duration ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries
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

The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Encephalitis
  • Biological: IC51
    0.25 ml, 2 intramuscular vaccinations at Day 0 and Day 28
  • Biological: IC51
    0.5 ml, 2 intramuscular vaccinations at Day 0 and 28
  • Biological: IC51
    0.5 ml, 2 i.m. vaccinations at Day 0 and 28
  • Experimental: >=2 months to <3 years
    IC51 0.25 ml, 2 intramuscular vaccinations at Day 0 and Day 28
    Intervention: Biological: IC51
  • Experimental: >=12 to <18 years
    IC51, 0.5 ml, 2 intramuscular 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
April 2014
August 2013   (final data collection date for primary outcome measure)

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.
Both
2 Months to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Denmark,   Germany,   Sweden
 
NCT01047839
IC51-322
Yes
Valneva Austria GmbH
Valneva Austria GmbH
Not Provided
Study Chair: Andrea Ayad, Dr. Valneva Austria GmbH
Valneva Austria GmbH
December 2013

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