Trial of the Reactogenicity, Safety and Immunogenicity of the Flu-M Vaccine Manufactured by FSUE SPbSRIVS FMBA
NCT05297994 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2022-03-28
Summary
To trial the reactogenicity, safety and immunogenicity of the Flu-M inactivated split influenza vaccine in volunteers aged 18-60 years
Conditions
Interventions
- BIOLOGICAL
-
Flu-M [Inactivated split influenza vaccine]
solution for intramuscular injection, 0.5 ml
- BIOLOGICAL
-
Inactivated influenza split vaccine
solution for intramuscular injection, 0.5 ml
Sponsors & Collaborators
-
St. Petersburg Research Institute of Vaccines and Sera
lead OTHER_GOV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-10-24
- Primary Completion
- 2016-12-12
- Completion
- 2017-03-09
Countries
- Russia
Study Locations
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