Study to Evaluate the Safety and Immunogenicity of Rabies Vaccine INDIRAB reconstituted with 1mL diluent Vs Reference Vaccine, administered Intramuscularly in healthy volunteers (Pre-Exposure).

Bharat Biotech International Limited,Genome Valley, Shameerpet,Ranga Reddy (Distict),Hyderabad-500 078.0 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

研究概览

暂无简介。

•Inclusion Criteria
•1.Subject between 18-55 years of age
•2.Subjects willing to give signed informed consent
•3.Subjects willing to give blood samples on recommended days
•4.Subjects available for follow up period
•1.Pregnancy & Lactation.
•2.Subjects who had received any type of rabies vaccination in the past.
•3.Subjects who had received rabies immunoglobulin (human / equine) in the past.
•4.Subjects who had suffered from any chronic illness or cancers.
•5.Subjects on steroids or any other immunosuppressant or is known to be HIV positive.
•6.Subjects planning for surgery in the next 3 months.
•7.Subjects on concomitant antimalarials.
•8.Subjects with history of allergy to any ingredient of the vaccine.
•9.Participation in another clinical trial in the past 3 months.
•10.Use of any marketed or investigational or herbal medicine or non registered drug or vaccine for rabies in the past 2 months.
•11.Past history of chronic alcoholic abuse.

•1)Pregnancy & Lactation.
•2)Subjects who had received any type of rabies vaccination in the past.
•3)Subjects who had received rabies immunoglobulin (human / equine) in the past.
•4)Subjects who had suffered from any chronic illness or cancers.
•5)Subjects on steroids or any other immunosuppressant or is known to be HIV positive.
•6)Subjects planning for surgery in the next 3 months.
•7)Subjects on concomitant antimalarials.
•8)Subjects with history of allergy to any ingredient of the vaccine.
•9)Participation in another clinical trial in the past 3 months.
•10)Use of any marketed or investigational or herbal medicine or non registered drug or vaccine for rabies in the past 2 months.
•11)Past history of chronic alcoholic abuse.

发起方

Bharat Biotech International Limited,Genome Valley, Shameerpet,Ranga Reddy (Distict),Hyderabad-500 078.