A Double-Blind, Randomized, Active Controlled Phase I Clinical Study to assess the Safety and Tolerability of SII Typhoid Conjugate Vaccine (Bivalent) in Healthy Adults

Serum Institute of India Pvt Ltd0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年3月4日

研究概览

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•1. Healthy adult male or female participants aged between 18-45 years [both inclusive] and normal Body Mass Index (18.50 to 24.99 kg/m2) [both inclusive] with minimum of 50 kg body weight.
•2. Normal health as determined by medical history, clinical examination and laboratory assessment.
•3. Participants willing to adhere to the protocol requirements and to provide written informed consent
•4. Participants residing in and around the study area during the study participation period.

•1. A known hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the similar components.
•2. Any serious adverse event with previous receipt of tetanus and/or diphtheria toxoid containing vaccines.
•3. History of suspected / laboratory confirmed S. Typhi or S. Paratyphi A infection.
•4. Previous vaccination for typhoid fever (either oral live attenuated or injectable vaccines).
•5. Household contact with known exposure to an individual with laboratory confirmed S. Typhi or S. Paratyphi A.
•6. Reactive serology for HIV, hepatitis B and hepatitis C viruses.
•7. Positive RPR test.
•8. History or presence of asthma, urticaria or other allergic reaction.
•9. Experienced significant acute, or chronic infections requiring systemic antibiotic treatment within the past 14 days.

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