NCT05401305

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: St. Petersburg Research Institute of Vaccines and Sera · Other Government
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Haemophilus Influenzae Infection
• Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	Vaccine for the prevention of infections caused by Haemophilus influenza type b	The vaccine is administered into the region of the deltoid muscle
BIOLOGICAL	Placebo	The placebo is administered into the region of the deltoid muscle

Timeline

• Start date: 2020-01-14
• Primary completion: 2020-03-30
• Completion: 2020-06-17
• First posted: 2022-06-02
• Last updated: 2022-06-02

Locations

1 site across 1 country: Russia