A multicentre single arm non-comparative Phase-IV post marketing study to evaluate the safety and tolerability of Biological E’s Live, Attenuated Measles-Rubella Vaccine (MR) in 9-12 month old Healthy Infants. - None

Biological ELimited0 个研究点目标入组 1,000 人开始时间: 待定最近更新: 2024年7月22日

试验速览

暂无简介。

•1. Healthy infants of either gender between 9-12 months of age at the time of first vaccination;
•2. Infants free of obvious health problems as established by medical history and physical examination before entering the study.
•3. Parent or LAR willing to provide written informed consent.
•4. Willing to strictly follow the study protocol requirements.

•1. Serious adverse event to any earlier vaccinations, as respiratory difficulty, angioedema and anaphylaxis;
•2. History of Measles, MR or MMR vaccination(s)
•3. Family history of any hypersensitivity reactions to Measles, MR or MMR vaccination(s) or allergy to any of their components.
•4. Acute or chronic illness or major congenital defects;
•5. Exposure to measles and rubella =30 days before study start;
•6. Use of blood products within 3 months before the vaccination;
•7. Use of any unregistered vaccine type within 30 days before the study vaccination ;
•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. 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

Biological ELimited