A Phase I Open Label Study to Evaluate the Safety, Tolerability and Immunogenicity of Biological E’s Live, Attenuated Measles Rubella Vaccine (MR) in 4-5 year Old Healthy Children. - None

Biological E Limited0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年7月22日

试验速览

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•1. Healthy male or female children, aged between 4-5 years at the time of first dose administration;
•2. Parent or legally acceptable representative capable to understand and willing to provide written informed consent including permission for audio-visual recording of the consent process;
•3. Willing to strictly follow the study protocol requirements;
•4. Understands and agrees not to allow the child / ward participate in another clinical trial at any time during the total study period;
•5. Parent(s) or legally acceptable representative’s Intellectual level which allows to filling in the diaries for registering of symptoms at home;
•6. Participants considered of stable health as judged by the investigator, determined by medical history and physical examination with normal vital signs as defined in the protocol. [Normal vital sign defined as body temperature <100.4ºF, pulse – 80 to 140 beats per minute, respiratory rate – 22 to 34 breaths per minute, prior to enrolment].
•7. Subjects without contraindications or precautionary circumstances.

•1. History of Serious adverse event to any earlier vaccinations, as respiratory difficulty, angioedema and anaphylaxis;
•2. Family or personal history of any hypersensitivity reactions to Measles, MR or MMR vaccinations;
•3. Acute or chronic illness or major congenital defects;
•4. Exposure to measles and rubella =30 days before study start;
•5. Use of blood products within 3 months before the vaccination;
•6. Use of any vaccine type within 30 days before the vaccination of the study;
•7. Any confirmed or suspected condition wherein the child is immunocompromised or receiving immunosuppressive medication;
•8. Use of any kind of investigational medication within 3 months before the study vaccination;
•9. Coagulopathies diagnosed by a physician or report of capillary fragility (ex: bruises or bleedings without justifiable cause);
•10. A history of neurologic disorders or seizures;
•11. Known history of HIV 1 & 2, HBV and HCV infection in participants prior to enrolment;
•12. Any criteria, which, in the opinion of the Investigator, suggests that the child would not be compliant with the requirements of the study protocol.

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