Determining Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine
Condition: Encephalitis, Japanese B
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: Live Japanese encephalitis vaccine SA 14-14-2 (LJEV); Measles Vaccine (MV)
Intervention description: Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) is lyophilized powder that looks like a milky-white crisp cake. After reconstitution, it turns into a transparent orange red liquid. Its container is a vial. It is stored and transported between 2°C to 8°C and protected from light. Each single human dose is 0.5 ml containing not less than 5.4 log particle flux unit (PFU) of live Japanese Encephalitis (JE) virus. The 0.5ml injection is delivered subcutaneously via auto-disable syringe. Lot number 200411129-3 manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China.; The Serum Institute of India (SII) measles vaccine provided routinely in the Expanded Program on Immunization (EPI) of the Philippines was the measles vaccine provided to the study participants. The vaccine met the requirements of the World Health Organization (WHO).
SII measles vaccine contained live attenuated (freeze-dried) Edmonston-Zagreb strain measles virus propagated on human diploid cells (HDC). Each single human dose when reconstituted in a volume of 0.5 ml contains no less than 1000 Cell culture infectious dose 50% (CCID50) of live virus particles. SII measles vaccine is presented as a yellowish-white dry cake. The vaccine should be reconstituted with the diluent supplied (sterile water for injection). A sterile disposable syringe and needle are supplied separately. The 0.5ml injection is delivered subcutaneously via auto-disable syringe. Lot number 2979.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 600.0
Sex: All
Minimum age: 8 Months
Maximum age: 11 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Japanese Encephalitis; Japanese B Encephalitis; Japanese B Viral Encephalitis; Viral Encephalitis, Japanese B

Summary:

      This study will determine whether it is safe and effective to administer Japanese
      encephalitis (JE) live attenuated SA 14-14-2 vaccine at the same time as measles vaccine. If
      it is found to be safe, it will pave the way for use in routine vaccination programs. The
      hypothesis is that children who receive JE live attenuated SA 14-14-2 vaccine and measles
      vaccine at the same time are protected against these diseases at the same level as those who
      receive the vaccines at different intervals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is healthy, aged between 8 months (± 2 weeks) at inclusion visit

          -  Subject is a full-term infant

          -  Subject's parents or legal guardian willing to provide signed informed consent.

          -  Children have completed 3 doses each of diphtheria, tetanus, pertussis (DTP) and oral
             polio vaccine (OPV).

        Exclusion Criteria:

          -  History of documented HIV.

          -  Known or suspected impairment of immunologic function.

          -  History of serious chronic disease

          -  Underlying medical condition such as inborn errors of metabolism, failure to thrive,
             bronchopulmonary dysplasia, or any major congenital abnormalities requiring surgery or
             chronic treatment.

          -  Acute medical illness with or without fever within the last 72 hours or an axillary
             temperature ≥ 37.5°C at the time of inclusion.

          -  History of documented suspected encephalitis, encephalopathy, or meningitis

          -  History of measles

          -  History of thrombocytopenic purpura.

          -  Received any JE or measles vaccine prior to enrollment.

          -  Received any vaccine, other than the study vaccines, within 2 weeks prior to or
             scheduled to receive a non-study vaccination during the conduct of this trial.

          -  Hypotonic - hyporesponsiveness, after the preceding vaccination.

          -  History of seizures, including history of febrile seizures, or any other neurologic
             disorder.

          -  Prior or anticipated receipt of immune globulin or other blood products, or injected
             or oral corticosteroids or other immune modulator therapy except routine vaccines
             within 6 weeks of administration of the study vaccines. Individuals on a tapering dose
             schedule of oral steroids lasting <7 days may be included in the trial as long as they
             have not received more than one course within the last 2 weeks prior to enrollment.

          -  Suspected or known hypersensitivity to any of the investigational or marketed vaccine
             components.

          -  Serious adverse event related to the vaccine (i.e., possible, probably, definite)

          -  Persistent inconsolable crying (>3 hours) observed after a previous dose.

          -  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
             participant, or interfere with the evaluation of the study objectives.