A Phase 1, double-blinded, Randomized, Active Controlled, Clinical Trial to assess the reactogenicity, safety and Immunogenicity of a recombinant poliomyelitis vaccine (rPV) in comparison with IPOL vaccine in healthy adults.

Serum Institute of India0 个研究点目标入组 36 人开始时间: 2026年7月27日最近更新: 2026年7月13日

适应症

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•Healthy Volunteers aged between 18 to 60 years inclusive.
•Good physical and mental health based on medical history, physical examination, clinical laboratory, electrocardiogram (ECG), and vital signs, as judged by the Investigator.
•Participants must refrain from strenuous exercise within 96 hours (4 days) prior to Screening, Day 1, Day 8, and Day 30..
•Willing and able to comply with restrictions of nicotine (i.e., tobacco and nicotine products) use throughout the study is not permitted from within 48 hours (2 days) prior to Screening, from Day 1 until Day 8, and within 48 hours (2 days) prior to the end of study visit.
•Participants must agree to use highly effective contraception from Day 1 until 90 days after the last study visit.

•History of Polio
•Any vaccination received 30 days before Screening and Day 30
•Pregnant or lactating females
•BMI >35.0kg/m2
•History of alcohol abuse or drug addiction
•Have received any polio vaccines within 6 months prior to screening.
•History of major surgeries
•History of receipt of a blood transfusion, other blood products, or immunoglobulins in 3 months prior to study vaccination
•any confirmed or suspected congenital or acquired immunosuppressive or immunodeficient condition.
•Positive drug and/or alcohol screen

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