NCT05457894

Trial of Tolerability, Reactogenicity, Safety and Immunogenicity of Flu-M [Inactivated Split Influenza Vaccine] in Pregnant Women

Randomized, Double-blind, Comparative, Controlled Trial of Tolerability, Reactogenicity, Safety and Immunogenicity of Flu-M [Inactivated Split Influenza Vaccine] in Pregnant Women During the 2nd - 3rd Trimester

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: St. Petersburg Research Institute of Vaccines and Sera · Other Government
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Influenza, Human
• Vaccination; Infection
• Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	Flu-M, Inactivated split influenza vaccine	solution for intramuscular injection, 0.5 ml
BIOLOGICAL	Ultrix®, Inactivated Split Influenza Vaccine	solution for intramuscular injection, 0.5 ml

Timeline

• Start date: 2020-01-23
• Primary completion: 2021-03-11
• Completion: 2021-07-26
• First posted: 2022-07-14
• Last updated: 2022-07-14

Locations

5 sites across 1 country: Russia