Determining Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine
Encephalitis, Japanese B
About this trial
This is an interventional prevention trial for Encephalitis, Japanese B focused on measuring Japanese Encephalitis, Japanese B Encephalitis, Japanese B Viral Encephalitis, Viral Encephalitis, Japanese B
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.
Sites / Locations
- Research Institute for Tropical Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
LJEV then MV
LJEV and MV
MV then LJEV
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.
Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.