The Objectives of This Study Are Study the Immunogenicity and Safety of the Flu-M [Inactivated Split Influenza Vaccine], vs. the Ultrix® Inactivated Split Influenza Vaccine, in Volunteers Who Are Over 60 Years Old
NCT05089123 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320
Last updated 2022-01-06
Summary
This trial by its design was a prospective, multicenter, double blind, randomized comparative clinical trial of the IIIb-IV phase which was carried out in parallel groups of volunteers over the age of 60
Conditions
Interventions
- BIOLOGICAL
-
Flu-M [Inactivated split influenza vaccine]
solution for intramuscular injection, 0.5 ml
- BIOLOGICAL
-
Inactivated Split Influenza 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
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-03-03
- Primary Completion
- 2020-05-28
- Completion
- 2020-08-24
Countries
- Russia
Study Locations
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