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COMPLETED
NCT07914244
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Poliomyelitis vaccine

A single 0.5 mL intramuscular dose of the Poliomyelitis vaccine was administered to 30 volunteers

OTHER

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