Status:
UNKNOWN
Reactogenicity, Safety and Immunogenicity of an Universal Influenza Vaccine Uniflu
Lead Sponsor:
VA Pharma Limited Liability Company
Conditions:
Safety Issues
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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...
Detailed 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,w...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Men and women aged 18 to 60 years old.
- Healthy that verificated by vital signs, physical examination, blood and urine lab tests
- Body mass index (BMI) from 18.5 to 30.5 weight \>50 kg
- Written informed consent.
- Consent to the use of effective contraceptive methods throughout the study period.
- Negative pregnancy test (for fertile women), consent to the use of effective contraceptive methods throughout the study period.
- Exclusion criteria
- Participation of a volunteer in any other study in the last 90 days; any vaccination in the last 30 days;
- Vaccination within 6 months before the start of the study (including during participation in other clinical trials).
- Symptoms of respiratory illness in the last 3 days.
- Symptoms of any acute in the screening period.
- Administration of immunoglobulins or other blood products for the last 3 months.
- Taking immunosuppressive drugs and / or immunomodulators within 6 months before the start of the study.
- Hypersensitivity or allergic reactions to the administration of any vaccine in medical history.
- The presence of anaphylactic reactions, angioedema or other SAE to the administration of any vaccine in medical history.
- Allergic reactions to vaccine components.
- Seasonal allergy (at autumn period).
- Acute or chronical desease or pathology from the gastrointestinal tract, liver, kidneys, cardiovascular system, central nervous system, musculoskeletal system, genitourinary and endocrine systems, which may influence the evaluation of the results of the study, in the anamnesis and also according to the screening examination data
- Leukemia or any other blood disease or malignancy of other organs.
- Thrombocytopenic purpura or bleeding disorders in medical history.
- Seizures in medical history.
- The presence or suspected presence of various immunosuppressive or immunodeficient state, including HIV infection.
- Hepatitis B and C.
- Tuberculosis.
- Regular past or current use of narcotic drugs.
- Pregnancy or breastfeeding.
- Any conditions which may influence the evaluation of the results of the study, in the anamnesis and also according to the screening examination data.
Exclusion
Key Trial Info
Start Date :
June 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03789539
Start Date
June 2 2018
End Date
December 31 2018
Last Update
December 28 2018
Active Locations (1)
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1
Research Institute of Influenza
Saint Petersburg, Sankt-Peterburg, Russia, 197376