Immunogenicity and Safety of Japanese Encephalitis Vaccine When Given With Measles-Mumps-Rubella (MMR) Vaccine
Condition: Encephalitis, Japanese; Measles; Mumps; Rubella
MeSH terms: Measles; Rubella; Mumps; Encephalitis, Japanese; Encephalitis
Intervention: Live attenuated SA 14-14-2 Japanese Encephalitis vaccine; Measles, mumps, rubella vaccine
Intervention description: Single 0.5 mL dose of World Health Organization prequalified live, attenuated SA 14-14-2 JE vaccine manufactured by Chengdu Institute of Biological Products, Chengdu, China, administered by subcutaneous injection; Single 0.5 mL dose of live, attenuated measles-mumps-rubella vaccine (Schwarz measles virus, RIT 4385 mumps strain, and Wistar RA 27/3 rubella virus) manufactured by GlaxoSmithKline, Inc., administered by subcutaneous injection.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 628.0
Sex: All
Minimum age: 9 Months
Maximum age: 9 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vaccine

Summary:

      This study aims to provide evidence that co-administration of measles-mumps-rubella vaccine
      (MMR) and live attenuated SA 14-14-2 Japanese encephalitis vaccine (CD-JEV) does not
      adversely affect immunogenicity or safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 9 months to < 10 months at the time of enrollment.

          -  Residence in the study area.

          -  At least one parent or guardian willing to provide written informed consent.

          -  Generally healthy and free of obvious health problems as established by medical
             history, physical examination, and clinical judgment.

          -  A parent or guardian is willing to attend all planned study visits and allow home
             visits and phone contacts, as required by the protocol.

        Exclusion Criteria:

          -  Previous receipt of any measles-mumps-rubella containing vaccine.

          -  Previous receipt of any Japanese encephalitis vaccine.

          -  History of measles, mumps, rubella, or Japanese encephalitis infection.

          -  Administration of any other vaccine within 28 days prior to administration of a study
             vaccine or planned vaccination of any vaccine other than catch-up doses of routine EPI
             vaccines or oral polio vaccine during the 28 days after study vaccination.

          -  History of allergic disease or known hypersensitivity to any component of the study
             vaccines and/or following administration of vaccines included in the local program of
             immunization.

          -  Use of any investigational or non-registered drug within 90 days prior to the
             administration of study vaccines or planned administration during the study period.

          -  Administration of immunoglobulins and/or any blood products within 90 days prior to
             the administration of study vaccines or planned administration during the study
             period.

          -  Chronic administration (defined as > 7 days) of immunosuppressing or other
             immune-modifying agents within 14 days before or after vaccination (including systemic
             corticosteroids equivalent to prednisone ≥ 0.5 mg/kg/day; topical and inhaled steroids
             are allowed).

          -  Primary or acquired immunodeficiency, including human immunodeficiency virus (HIV)
             infection, or a family history of congenital or hereditary immunodeficiency as
             reported by parent.

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal
             functional abnormality, as determined by medical history or physical examination,
             which might interfere with the study objectives.

          -  Severely malnourished infants as measured by World Health Organization
             weight-for-height tables (Z-score < -3).

          -  Any condition or criterion that, in the opinion of the study physician, might
             compromise the well-being of the participant, compliance with study procedures, or
             interpretation of the outcomes of the study.

          -  Acute illness at the time of enrollment defined as the presence of a moderate or
             severe illness with fever (axillary temperature ≥ 38.0°C) or without fever (severity
             determined at the discretion of the study physician). Acute illness is a temporary
             exclusion. Vaccination should be postponed at least 7 days after recovery. A visit for
             reassessment may be scheduled 7 days or more after temporary exclusion illness is
             resolved. Eligibility for study participation must be reassessed again at the next
             visit.