Lot-to-lot Consistency Trial of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: Vaccine produced in existing facility; Vaccine produced in new facility
Intervention description: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China; Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 818.0
Sex: All
Minimum age: 10 Months
Maximum age: 12 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The proposed study is a four-arm double-blind randomized controlled single center trial to
      evaluate, by examining post-vaccination seroprotection titers, the lot-to-lot consistency of
      three lots of Japanese Encephalitis live attenuated SA 14-14-2 vaccine (LJEVac) manufactured
      in a new good manufacture practice (GMP) facility, and to establish non-inferiority of the
      new vaccine in comparison to a single lot of the same vaccine manufactured in the existing
      facility. The study aimed to enroll a total of 1,000 Bangladeshi infants aged 10 to 12
      months. In addition to providing immunogenicity data, this study provided local safety data
      of JE live attenuated SA 14-14-2 vaccine among Bangladeshi children. This is the first step
      to secure licensure for this life-saving vaccine in Bangladesh as well as provide data to
      support WHO prequalification of JE live attenuated SA 14-14-2 vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infant's parent(s) or legal guardian(s) willing to provide signed informed consent.

          -  Healthy infants aged 10 to 12 months at enrolment residing in Matlab Health and
             Demographic Surveillance System (HDSS) intervention area who have completed all doses
             of Expanded Programme on Immunization (EPI) immunizations at least 4 weeks prior to
             enrolment: Bacillus Calmette-Guerin vaccine (BCG), Diphtheria-pertussis-tetanus
             vaccine (DPT), Hepatitis B (HBV), Haemophilus influenzae type (Hib), oral polio
             vaccine (OPV) and measles

        Exclusion Criteria:

          -  Acute medical illness with or without fever within the last 72 hours or an axillary
             temperature (≥ 37.5°C ) at the time of vaccination.

          -  Use of antibiotics or antipyretics within the last 72 hours prior to enrolment.

          -  Severely or moderately malnourished infants (<-3 Z score).

          -  History of prematurity (< 36 weeks of pregnancy).

          -  Underlying medical condition such as failure to thrive, inborn errors of metabolism,
             bronchopulmonary dysplasia, or any major congenital abnormalities requiring surgery or
             chronic treatment.

          -  History of serious chronic disease (e.g., cardiac, renal, neurologic, metabolic,
             rheumatologic, hematologic, or bleeding disorder).

          -  Known or suspected impairment of immunologic function.

          -  History of documented or suspected encephalitis or meningitis.

          -  History of seizures, including history of febrile seizures, or any other neurologic
             disorder.

          -  History of JE infection.

          -  Prior receipt of a JE vaccine.

          -  Received measles vaccine within 4 weeks prior to, or scheduled to receive a
             vaccination during, the conduct of this trial.

          -  Prior or anticipated receipt of immune globulin or other blood products, or injected
             or oral corticosteroids or other immune modulator therapy within 6 weeks of
             administration of the study vaccine.

          -  Serious adverse reactions (e.g. urticaria, angioedema, shock, breathlessness following
             vaccination or any life threatening condition) with any previous EPI vaccine.

          -  Unable to attend the scheduled visits or comply with the study procedures.

          -  Enrolled in another clinical trial involving any therapy.

          -  Any condition that in the opinion of the investigator, would pose a health risk to the
             child, or interfere with the evaluation of the study objectives.