An Open-Label, Randomized, Phase I Study in Healthy MaleAdults to Evaluate the Safety of a Measles Vaccine (Dry Powder)Administered by Two Devices - PMV

Serum Institute of India Limited0 个研究点目标入组 60 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. Male adults of age of 18-45 years.
•2. Measles immune, as determined by IgG antibody levels.
•3. Healthy as supported by medical history, physical examination and laboratory evaluation on preset parameters.
•4. Signed informed consent for participation in trial and for HIV screening.
•5. Expressed interest and availability to fulfill the study requirements.
•6. Willing not to have other experimental vaccination from â??30 days to 180 days after study vaccination.

•1.Medical history of immunodeficiency/suppression or subject with history of close contact with
•immunocompromised/ immunosuppressed person.
•2. Chronic administration of immunosuppressants or other immune modifying agents
•3. Acute febrile illness or suspected measles illness or acute infectious disease
•4. Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, psychiatric, cardiovascular, neurological, hepatic or renal functional abnormality which in the opinion of the investigator, might interfere with the study objectives
•5. History of seizure disorders
•6. Major congenital defects
•7. Thrombocytopenia or known bleeding disorders 8. History of a previous severe allergic reaction
•9. Positive serology for HIV antibody, HCV antibody or Hepatitis B surface antigen
•10. Known hypersensitivity to any component of the
•study vaccine.

发起方

Serum Institute of India Limited