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Safety and Reactogenicity Trial of Vaccine for the Prevention of Infections Caused by Haemophilus Influenzae Type b

Vaccines Clinical Trial

Official title:
Simple Blind, Placebo Controlled, Randomized Safety and Reactogenicity Trial of "Baby-Hib [Vaccine for the Prevention of Infections Caused by Haemophilus Influenzae Type b], Lyophilizate for Preparation of Intramuscular Injection Solution, 0.5 mL/Dose", FSUE SPbSRIVS FMBA of Russia, in Volunteers Aged 18-50

Clinical Trial Summary

Trial purpose is to evaluate the safety, tolerability and reactogenicity of the Vaccine for the prevention of infections caused by Haemophilus Influenzae Type b in volunteers aged 18-50.

Clinical Trial Description

The trial includes 2 stages (Stage I and Stage II). The aim of the Stage I is to assess the tolerability, reactogenicity and safety of the Hib vaccine in the first 10 volunteers during the first 7 days after vaccination. The aim of the Stage I is to assess the tolerability, reactogenicity and safety of the Hib vaccine during 28 days after vaccination and also to conduct a comparative assessment of the safety and reactogenicity of the Hib vaccine and placebo during 28 days after vaccination. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05401305
Study type Interventional
Source St. Petersburg Research Institute of Vaccines and Sera
Contact
Status Completed
Phase Phase 1
Start date January 14, 2020
Completion date June 17, 2020
View Details
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