A Phase I Open Label Study to Evaluate the Safety and Tolerability of Biological Eâ??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: 2021年11月24日

试验速览

暂无简介。

•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 the impossibility of participating in another clinical trial during the time of participation in the study;
•5.Parent(s) or legally acceptable representativeâ??s Intellectual level which allows to filling in the diaries for registering of symptoms at home;
•6.Lab examination at screening period within the acceptable limits as judged by the investigator, determined by the laboratory reports;
•7.Subjects without contraindications or precautionary circumstances.

•1.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.Positive HIV, HBV and HCV tests at screening examination;
•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.

发起方