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Clinical Study of the Tolerability, Reactogenicity, and Safety of PoliovacSin in Volunteers Aged 18-60 Years
Sponsor: Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products
Summary
This is a double-blind, placebo-controlled, randomized, single-center study to evaluate the tolerability, reactogenicity, and safety of the vaccine PoliovakSin in healthy adult volunteers aged 18 to 60 years. A total of 60 volunteers who met the eligibility criteria after screening will receive either the PoliovakSin vaccine or a placebo. Participants will be followed for 28 days after vaccination. Safety assessments include physical examination, vital signs, ECG, neurological status, laboratory tests (hematology, blood chemistry, urinalysis, total IgE), monitoring of adverse events and serious adverse events, and a participant self-observation diary. The study will also compare the tolerability, reactogenicity, and safety of the vaccine with those of the placebo.
Official title: Double-blind, Placebo-controlled Clinical Study of the Tolerability, Reactogenicity, and Safety of PoliovacSin (Purified, Concentrated, Inactivated Liquid Polio Vaccine Derived From Attenuated Sabin Strains) in Volunteers Aged 18-60 Years
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2018-01-29
Completion Date
2018-03-06
Last Updated
2026-11-03
Healthy Volunteers
Yes
Conditions
Interventions
Poliomyelitis vaccine
A single 0.5 mL intramuscular dose of the Poliomyelitis vaccine was administered to 30 volunteers
Placebo comparator (without active ingredient)
A single 0.5 mL intramuscular dose of the Placebo was administered to 30 volunteers
Locations (1)
Federal State Budgetary Healthcare Institution "Medical and Sanitary Unit No. 163 of the Federal Medical and Biological Agency"
Novosibirsk, Novosibirsk Oblast, Russia