Reactogenicity, Safety and Immunogenicity of an Universal Influenza Vaccine Uniflu

Safety Issues Clinical Trial

Official title: Reactogenicity, Safety and Immunogenicity of an Recombinant Universal Influenza Vaccine Uniflu in Healthy Volunteers From 18 to 60 Years Old

Status Active, not recruiting

Clinical Trial Summary

This is a single-site, randomized, double-blind, placebo-controlled study of Uniflu in fifty four (54) volunteers 18-60 years of age with a dose escalation.

All subjects will receive an intramuscular (IM) injection twice,with a 21 days interval between treatments.

Clinical Trial Description

This is a single-site, randomized, double-blind, placebo-controlled study of Uniflu in fifty four (54) volunteers 18-60 years of age.

All subjects will receive an intramuscular (IM) injection twice,with a 21 days interval between treatments.

Subjects will undergo screening procedures within 6 days prior to first vaccination which will include medical history, vital signs, physical examination and safety blood and urine lab tests.

On the first treatment visit, eligible subjects will undergo pre-dose physical examination,vital signs, ECG, a blood sample will be drawn for circulating IgE. They receive an IM injection of either vaccine or placebo, according to the above treatment assignment, into the deltoid muscle. The subjects will remain under medical supervision for 72 hrs, after that time they will be released from the Clinical research center.

The second treatment will take place 21 days after the first vaccination. Procedures will be the same as on the first treatment visit.

Follow-up visits take place at 4th, 5th, 6th, 14th, 35th days. A Study Termination visit will take place at 42nd day of research. Adverse events (AEs) and changes in concomitant medications will be recorded, vital signs will be measured and the subjects will undergo physical examination and ECG. Blood and urine samples will be collected for safety. ;

Related Conditions & MeSH terms

• Influenza, Human
• Safety Issues

• NCT number: NCT03789539
• Study type: Interventional
• Source: VA Pharma Limited Liability Company
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: June 2, 2018
• Completion date: December 31, 2018