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

NCT05457894 | Completed Phase 3

• 1 other identifier: FM-2019-01
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Influenza; Flu; Vaccine; FLU-M; SPbSRIVS; Ultrix

Outcome Measures

Primary Outcomes (3)

• Change from Baseline Seroprotection rate at day 21 after vaccination

  The percentage of vaccinees who have an antibody titer of more than 1:40 by Day 21 after vaccination. Antibodies to influenza B, А (H1N1), А (H3N2) viruses Seroprotection rate ≥ 70%.

  Days 0 (screening), 21

• Change from Baseline Seroconversion rate at day 21 after vaccination

  The relative number of vaccinees, whose titer of hemagglutinin inhibiting antibodies has increased by more than 4 times vs. baseline among all immunoprotective persons. Antibodies to influenza B, А (H1N1), А (H3N2) viruses Seroconversion rate ≥ 40%

  Days 0 (screening), 21

• Change from Baseline Seroconversion factor at day 21 after vaccination

  An increase in the geometric mean titers of hemagglutinin inhibiting antibodies on Day 21 vs. baseline, expressed in multiplicity of increase. Antibodies to influenza B, А (H1N1), А (H3N2) viruses Seroconversion factor ≥ 2.5

  Days 0 (screening), 21

Secondary Outcomes (16)

• Incidence of AEs and SAEs associated with vaccination

  Day 1 (30 minutes, 3 and 5 hours after vaccination), days 2-21

• Number of participants with abnormal changes in physical examination data

  Days 0-7, day 21

• Number of participants with abnormal changes in vital signs - Blood pressure (BP)

  Days 0-7, day 21

• Number of participants with abnormal changes in vital signs - Heart rate (HR)

  Days 0-7, day 21

• Number of participants with abnormal changes in vital signs - Respiratory rate (RR)

  Days 0-7, day 21

Study Arms (4)

Flu-M, II trimester of pregnancy

EXPERIMENTAL

Subjects during their II trimester of pregnancy (gestational age: 14-26 weeks), immunized once with the Flu-M vaccine.

Biological: Flu-M, Inactivated split influenza vaccine

Ultrix®, II trimester of pregnancy

ACTIVE COMPARATOR

Subjects during their II trimester of pregnancy (gestational age: 14-26 weeks), immunized once with Ultrix®.

Biological: Ultrix®, Inactivated Split Influenza Vaccine

Flu-M, III trimester of pregnancy

EXPERIMENTAL

Subjects during their III trimester of pregnancy (gestational age: 27-32 weeks), will be immunized once with the Flu-M vaccine.

Biological: Flu-M, Inactivated split influenza vaccine

Ultrix®, III trimester of pregnancy

ACTIVE COMPARATOR

Subjects during their III trimester of pregnancy (gestational age: 27-32 weeks), immunized once with Ultrix®.

Biological: Ultrix®, Inactivated Split Influenza Vaccine

Interventions

Flu-M, Inactivated split influenza vaccine BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Flu-M, II trimester of pregnancy; Flu-M, III trimester of pregnancy

Ultrix®, Inactivated Split Influenza Vaccine BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Ultrix®, II trimester of pregnancy; Ultrix®, III trimester of pregnancy

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Healthy women aged 18 to 35 years during the 2nd and 3rd trimesters of pregnancy.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Presence of signed Informed Consent of the female patient to participate in the trial
• Healthy women aged 18 to 35 years in their 2nd and 3rd trimesters of pregnancy with gestational age of no more than 32 weeks
• Singleton pregnancy progressing normally
• No contraindications for vaccination
• Pregnant women that are able to fulfill the requirements of the protocol (i.e., fill out the Self-Observation Diary, come to follow-up visits)
• The investigator is given the opportunity to collect data about somatic, infectious, and allergic diseases within at least 3 months from vaccination (one or more calls from the clinical investigator or visits per month (as needed))

You may not qualify if:

• Body temperature above 37°С
• History of influenza or previous influenza vaccination during 6 months before the screening
• History of allergic reactions to chicken protein
• Allergic reactions to vaccine components or any previous vaccination
• Gestational toxicosis
• Any disorders of pregnancy
• Thyroid disorders
• Bronchial asthma
• Clotting disorders
• , 2 type diabetes mellitus
• High risk of fetal chromosomal abnormalities (individual risk of at least 1/100) in the 1st trimester of pregnancy and/or the detection of fetal congenital anomalies / developmental defects in the 1st, 2nd, and 3rd trimesters of pregnancy
• Strong reaction (temperature above 40 °C, hyperemia or edema more than 8 cm in diameter) or complications (collapse or shock-like condition) that developed within 48 hours from prior vaccination; convulsions accompanied or not accompanied by a fever due to any prior vaccination
• Acute infectious or non-infectious diseases less than 4 weeks before the screening, exacerbation of chronic diseases (the vaccination can be carried out after recovery or in the period of remission)
• Immunomodulatory therapy, including immune-enhancing, immunosuppressive therapy (corticosteroids, cytotoxic and radioactive drugs) in the 6 months preceding the trial
• Any other contraindications against vaccination according to the investigator.

Sponsors & Collaborators

• St. Petersburg Research Institute of Vaccines and Sera: lead

Study Sites (5)

Federal State Budgetary Educational Institution of Higher Education "Altai State Medical University" of the Ministry of Health of the Russian Federation

Barnaul, Altai Territory, Russia

Location

Federal State Budgetary Institution "Siberian Federal Scientific and Clinical Center of Federal Medical and Biologic Agency"

Seversk, Tomsk Oblast, Russia

Location

"Curator" Limited Liability Company

Saint Petersburg, Russia

Location

KOROLEV MEDICINE Limited Liability Company

Saint Petersburg, Russia

Location

Municipal Budgetary Institution "Central City Hospital No.7"

Yekaterinburg, Russia

Location

MeSH Terms

Conditions

Influenza, Human; Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Ellina Ruzanova, PhD

  St. Petersburg Research Institute of Vaccines and Sera

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: January 23, 2020
• Primary Completion: March 11, 2021
• Study Completion: July 26, 2021
• Last Updated: July 14, 2022

Record last verified: 2022-07

Locations

RU (5)