Live Attenuated Japanese Encephalitis (JE) Vaccine Coadministered With Measles Vaccine in Infants 9 Months of Age
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine; Live, attenuated measles vaccine
Intervention description: Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium.; Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 278.0
Sex: All
Minimum age: 9 Months
Maximum age: 9 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To facilitate introduction of live attenuated SA 14-14-2 Japanese encephalitis vaccine (LJEV)
      into the National Immunization Programme of Sri Lanka, we evaluated the safety and
      immunogenicity of co-administration of LJEV and measles vaccine at 9 months of age. The
      primary hypothesis was that the seropositivity rate at 28 days post vaccination in Japanese
      Encephalitis (JE) and measles concomitantly vaccinated subjects 9 months of age is greater
      than 80% for JE and greater than 90% for measles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy child 9 months (±2 weeks) of age at the enrollment visit.

          -  Subject was a full-term infant.

          -  Subject's parent or legal guardian is literate and willing to provide written informed
             consent.

          -  Subject is up-to-date for all vaccinations recommended in the Sri Lankan childhood
             immunization schedule.

        Exclusion Criteria:

          -  Enrolled in another clinical trial involving any therapy.

          -  Subject and/or parent(s) or guardian(s) are unable to attend the scheduled visits or
             comply with the study procedures.

          -  Received any non-study vaccine within 2 weeks prior to enrolment or refusal to
             postpone receipt of such vaccines until 28 days after study entry.

          -  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 study vaccine. 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 enrolment.

          -  History of documented or suspected encephalitis, encephalopathy, or meningitis.

          -  History of measles.

          -  History of Japanese encephalitis.

          -  Serious adverse event related (i.e., possible, probably, definite) to previous receipt
             of any JE vaccine, if applicable.

          -  Persistent inconsolable crying (>3 hours) observed after previous receipt of any JE
             vaccine, if applicable.

          -  Hypotonic - hyporesponsiveness after past receipt of any JE vaccine, if applicable.

          -  Suspected or known hypersensitivity to any of the investigational or marketed vaccine
             components.

          -  History of serious chronic disease (cardiac, renal, neurologic, metabolic, or
             rheumatologic).

          -  Underlying medical condition such as inborn errors of metabolism, failure to thrive,
             bronchopulmonary dysplasia, or any major congenital abnormalities requiring surgery or
             chronic treatment.

          -  History of thrombocytopenic purpura.

          -  History of seizures, including history of febrile seizures, or any other neurologic
             disorder.

          -  Known or suspected immunologic function impairment of any kind and/or known HIV
             infection.

          -  Parent with known or suspected immunologic function impairment of any kind and/or
             known HIV infection.

          -  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.