Safety and Efficacy Study of ChimeriVax™-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: ChimeriVax™-JE; Japanese Encephalitis Inactivated Mouse Brain Vaccine
Intervention description: One dose of 4.0 log10 PFU is given in a volume of 1 ml for children aged > 3 years and 0.5 ml to children and infants aged < 3 years administered subcutaneously; Two doses of 1 ml reconstituted JE-MBDV is given to subjects aged > 3 years and 0.5 ml is given to children and infants aged < 3 years administered subcutaneously
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 96.0
Sex: All
Minimum age: 9 Months
Maximum age: 10 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Japanese Encephalitis

Summary:

      This randomised, double-blind study is to be conducted on 96 subjects at multiple sites in
      India. Subjects will be enrolled by age group and randomised to either ChimeriVax™-JE (JE-CV)
      or JE Mouse Brain Derived Vaccine (JE-MBDV). Study consists of a screening period, a
      treatment period and a 2 year follow-up period.

      Primary safety endpoints will be the adverse event (AE) rates 28 days after completion of
      vaccination course. The primary efficacy endpoints will be the rate of seroconversion 28 days
      after completing vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All aspects of the Protocol explained and written informed consent obtained from the
             subject's parent or guardian and assent from the child if ≥ 8 years of age.

          -  Aged ≥ 9 months to < 10 years

          -  In good general health, without significant medical history, physical examination
             findings, or clinically significant abnormal laboratory results

          -  Subject had to be available for the study duration for the study duration, including
             all planned follow-up visits.

        Exclusion Criteria:

          -  A history of vaccination against, or infection with, JE or other flaviviruses (e.g.
             Kyanasur Forest Disease, West Nile virus, dengue fever). Previous JE vaccination was
             to be determined by history (interview of subject's parent or guardian) or by
             inspecting the child's official vaccination record.

          -  Demonstration of parasitemia on malaria blood smear at Screening.

          -  History of residence in or travel to a JE-endemic region of India or elsewhere in Asia
             (for periods of 4 weeks or more).

          -  hypersensitivity to thimerosal or gelatin

          -  Have received a transfusion of blood, blood products or serum globulin in the
             preceding 6 months,

          -  Have an immunodeficiency or neurological disorder, or take drugs that suppress the
             immune system,

          -  Have a history of severe reaction to other vaccines,

          -  Have a chronic condition requiring medication,

          -  Intend to travel out of the area during the study period,

          -  Have spent at least 4 weeks in a JE-endemic region,

          -  Plan to receive any other vaccination within the double-blind treatment period, or who
             have received a vaccination in the month preceding Screening,

          -  Exhibit signs of secondary or tertiary malnutrition,

          -  Are seropositive to human immunodeficiency virus (HIV), Hepatitis B or C,

          -  Have malaria infection, or who have a fever within 3 days before vaccination.

          -  Those with an acute fever, or with previously scheduled vaccinations, may be
             rescheduled.

          -  Consideration of the routine immunisation schedule should be made such that it is
             ensured that routine vaccinations due are either given before entry to the trial, or
             afterwards if delayed because of the trial.