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Clinical Trial Summary

Comparative study of tolerability, reactogenicity, safety and immunogenicity Flu-M [Inactivated Split Influenza Vaccine] vs. the Ultrix® vaccine for the prevention of influenza in pregnant women in the 2nd-3rd trimesters of pregnancy


Clinical Trial Description

This is a randomized, double-blind, comparative, controlled trial. A design with a control group treated with Ultrix®, inactivated influenza vaccine, was chosen to obtain objective findings.Trial population: healthy women aged 18 to 35 years during the 2nd and 3rd trimesters of pregnancy. Subjects were randomized into 4 groups in a ratio of 1:1:1:1, 50 subjects per group. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05457894
Study type Interventional
Source St. Petersburg Research Institute of Vaccines and Sera
Contact
Status Completed
Phase Phase 3
Start date January 23, 2020
Completion date July 26, 2021

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