MedTrace Logo

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

NCT05457894 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2022-07-14

No results posted yet for this study

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

Conditions

  • Influenza, Human
  • Vaccination; Infection
  • Vaccines

Interventions

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

Sponsors & Collaborators

  • St. Petersburg Research Institute of Vaccines and Sera

    lead OTHER_GOV

Principal Investigators

  • Ellina Ruzanova, PhD · St. Petersburg Research Institute of Vaccines and Sera

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-23
Primary Completion
2021-03-11
Completion
2021-07-26

Countries

  • Russia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05457894 on ClinicalTrials.gov