NCT05152017

The Objectives of This Study Are Study the Safety, Reactogenicity and Obtain Preliminary Data on the Immunogenicity of Flu-M Quadro, 4-valent Inactivated Split Influenza Vaccine, in Healthy Volunteers

Phase I Simple Blind, Placebo Controlled, Randomized Safety and Reactogenicity Trial of the Flu-M Quadro Tetravalent Inactivated Split Influenza Vaccine, Solution for Intramuscular Injection, Produced by FSUE SPbSRIVS FMBA, vs. Placebo in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: St. Petersburg Research Institute of Vaccines and Sera · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The study the safety, reactogenicity and obtain preliminary data on the immunogenicity of Flu-M Quadro, 4-valent inactivated split influenza vaccine, in healthy volunteers

Detailed description

The maximum period of the volunteers' participation in the trial will be 35 ± 2 days. Screening period - up to 7 days. The vaccine administration period is 1 day. Follow-up period - 28±2 days. All volunteers are followed by a clinical investigator for 6 months after vaccination outside of this trial with the aim of detecting possible late adverse reactions. If a volunteer has any delayed-type reactions, the volunteer will be invited to the clinic for correction of his/her condition.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Flu-M Quadro [inactivated split influenza vaccine] with preservative	solution for intramuscular injection, 0.5 ml
BIOLOGICAL	Flu-M Quadro [inactivated split influenza vaccine] without preservative	solution for intramuscular injection, 0.5 ml
BIOLOGICAL	Placebo	solution for intramuscular injection, 0.5 ml

Timeline

• Start date: 2019-11-16
• Primary completion: 2020-01-22
• Completion: 2020-01-24
• First posted: 2021-12-09
• Last updated: 2022-01-06

Locations

1 site across 1 country: Russia