A phase IIIopen label study to evaluate safety and immunogenicity in healthy volunteers followed by non-interference immune response study of inactivated Japanese encephalitis vaccine (JENVACÃ?Â®) when co-administered with Measles, Mumps and Rubella (MMR) vaccine. - JENVACÃ?Â®

Bharat Biotech International Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1 Healthy infants between Ã¢â?°Â¥9 months to 12 months (for step 1); and Ã¢â?°Â¥8 to 10 months of age (for step II) at the time of enrolment.
•2 Subject parents or legally acceptable representative is willing to provide signed informed consent.
•3 Subjects parents OR LAR intend to remain in the area with the subject during the study period and be available for follow up

•1 Acute medical illness with or without fever within the last 72 hours or an axillary temperature of 38.1 degree C to 39 degree C at the time of screening.
•2 History of documented suspected encephalitis, encephalopathy or meningitis
•3 Received any JE or MMR vaccine prior to screening.
•4 History of hypotonic hypo responsiveness following vaccination.
•5 History of seizures or febrile seizures or any other neurologic disorder
•6 Prior or anticipated receipt of immunoglobulin or other blood products or injected or oral corticosteroids or other immune modulator therapy except for routine vaccines within 6 weeks of administration of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting less than 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.
•7 History of documented HIV.
•8 Known or suspected impairment of immunologic function.
•9 Enrolled in another clinical trial involving any therapy the subject should not participate in any clinical trial during the entire study period.
•10 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

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