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Reactogenicity, Safety and Immunogenicity of an Universal Influenza Vaccine Uniflu

NCT03789539 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2018-12-28

No results posted yet for this study

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.

Conditions

  • Safety Issues

Interventions

BIOLOGICAL

LD Universal Influenza Vaccine Uniflu

low dose Universal Influenza Vaccine Uniflu

BIOLOGICAL

HD Universal Influenza Vaccine Uniflu

High dose Universal Influenza Vaccine Uniflu

BIOLOGICAL

Placebo

Placebo saline

Sponsors & Collaborators

  • VA Pharma Limited Liability Company

    lead INDUSTRY

Principal Investigators

  • Julia M Savateeva, PhD · VA Pharma Limited Liability Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-02
Primary Completion
2018-12-02
Completion
2018-12-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03789539 on ClinicalTrials.gov