Immunogenicity and safety of JENVAC and JEEV vaccines administered for prevention of Japanese encephalitis in an interchangeable dosing schedule among healthy Indian children: A multicentric, phase IV, open-labeled, randomized controlled trial - Nil

Indian Council of Medical Research0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年7月25日

试验速览

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•A child will be included in the study if all of the following criteria are fulfilled:
•1.Healthy, as established by medical history and clinical examination by a pediatrician.
•2.Age between 9-12 months at the time of enrolment.
•3.Parental ability and willingness to provide informed consent.
•4.Parents (or legal guardian) who have been residents of the study area for atleast the past 6 months and intend to remain in the area with the child during the study period.

•Any of the following conditions will exclude children from the study:
•1.Presence of febrile illness in the previous 72 hours or on the day of enrolment (temporary exclusion).
•2.Acute disease at the time of enrolment (temporary exclusion).
•3.Concurrent participation in another clinical trial throughout the entire timeframe for this study.
•4.History of severe hypersensitivity reaction to injections including other vaccines received in past
•5.Presence of significant malnutrition (weight-for-height z-score <-3SD median)
•6.Any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease), congenital or acquired, as determined by medical history and/or physical examination.
•7.Acute infectious disease, active tuberculosis; otitis media
•8.History of epilepsy and any diagnosed neurological disorder
•9.Known or suspected impairment of immunological function based on medical history and physical exam.
•10.Prior receipt of JE vaccine.
•11.Receipt of any immunoglobulin therapy and/or blood products since birth.
•12.H/O chronic administration ( >14 days) of immunosuppressants including corticosteroids.
•13.Any medical condition in the parents/infant which, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participantâ??s parentsâ?? ability to give informed consent.

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