A Randomized, Open Label, Active Controlled, Phase II/III Clinical Study to Assess the Safety and Immunogenicity of SIILâ??s Purified Vero Cell Rabies Vaccine (PVRV) in Patients with Potential Rabies Exposure - PVRV of SII

Serum Institute of India Limited0 个研究点目标入组 181 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Patients aged more than or equal to 5 years.
•2.WHO Category II and III exposure(s) by a suspected rabid animal < 72 hours prior to enrollment and < 24 hours if exposure to face, neck, hand or fingers.
•3.Written informed consent by subjects (more than or equal to 18 years) / parents or legal guardian of subjects (5 - 17 years).
•4.Written informed assent by subjects aged 13 - 17 years
•5.Free of obvious health problems as established by medical history and clinical examination.
•6.A woman of child bearing potential must agree not to become pregnant and a man must agree not to father a child, until the completion of the study period by using appropriate contraceptive methods.

•1.Previous receipt of rabies immune globulin and /or rabies vaccine.
•2.Chronic administration of immunosuppressants or other immune-modifying agents within six months prior to administration of study medications.
•3.Acute febrile illness or acute infectious disease.
•4.Acute or chronic, clinically significant abnormality which in the opinion of the investigator might interfere with the study objectives.
•5.Major congenital defects or serious chronic illness.
•6.History of thrombocytopenia or known bleeding disorders.
•7.History of a previous severe allergic reaction.
•8.Pregnant and lactating women.
•9.Receipt of other investigational study agent within previous 30 days or planned during the course of this study.
•10.Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study or making it unlikely the subject could complete the protocol.

发起方

Serum Institute of India Limited