A Phase II/III, Randomized, Multi-centric, Comparator-controlled Study of the Safety and Neutralizing Activity of a Human Monoclonal Antibody to Rabies (SII RMAb) Administered in Conjunction with Rabies Vaccine for Post-exposure Prophylaxis in Patients following Potential Rabies Exposure

Serum Institute of India Ltd Pune India0 个研究点目标入组 200 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 5 years or more than 5 years (Initially 10 adults )
•2.WHO Category III exposure(s) by a suspected rabid animal
•3.Written informed consent by subjects (18 years and more) / parents of subjects (5-17 years).
•4.Written informed assent by subjects aged 7-17 years
•5.Free of obvious health problems.
•6.A woman of child bearing age 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.
•3.Acute febrile illness or acute infectious disease.
•4.Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, psychiatric, cardiovascular, hepatic or renal functional 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 with generalized urticaria; angioedema or anaphylaxis.
•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.

发起方

Serum Institute of India Ltd Pune India