The primary purpose of this study is to test a new experimental recombinant Poliomyelitis vaccine (rPV) in comparison to the commercially available inactivated poliovirus vaccine. The design of the study is double-blinded, randomised and active controlled. The active controlled product is considered the commercially available vaccine (IPOL).
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) usethroughout the study is not permitted from within 48 hours (2 days) prior to Screening, from Day 1 until Day8, and within 48 hours (2 days) prior to the end of study visit.
History of Polio
Any vaccination received 30 days before Screening and Day 30
Pregnant or lactating females
BMI >35.0kg/m2
Parallel
Recombinant Poliomyelitis Vaccine (rPV)
Biological/VaccineRecombinant Poliomyelitis Vaccine (VLP) is manufactured by Serum Institute of India Pvt. Ltd.
Inactivated Poliomyelitis Vaccine (IPOL)
Biological/VaccineIPOL (inactivated poliovirus vaccine) is a marketed Sanofi
The incidence, severity and relationship of solicited adverse events (AEs) during 7-day and unsolicited AEs during 30-day follow-up period after rPV and IPOL vaccination
Percentage of participants achieving seroprotection/seroconversion for poliovirus Types 1, 2 and 3, on Day 30.
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