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

NCT ID: NCT05457894

Last Updated: 2022-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-23
• Study Completion Date: 2021-07-26

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Flu-M, II trimester of pregnancy

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

Group Type: EXPERIMENTAL

Flu-M, Inactivated split influenza vaccine

Intervention Type: BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Ultrix®, II trimester of pregnancy

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

Group Type: ACTIVE_COMPARATOR

Ultrix®, Inactivated Split Influenza Vaccine

Intervention Type: BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Flu-M, III trimester of pregnancy

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

Group Type: EXPERIMENTAL

Flu-M, Inactivated split influenza vaccine

Intervention Type: BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Ultrix®, III trimester of pregnancy

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

Group Type: ACTIVE_COMPARATOR

Ultrix®, Inactivated Split Influenza Vaccine

Intervention Type: BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Interventions

Flu-M, Inactivated split influenza vaccine

solution for intramuscular injection, 0.5 ml

Intervention Type: BIOLOGICAL

Ultrix®, Inactivated Split Influenza Vaccine

solution for intramuscular injection, 0.5 ml

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Presence of signed Informed Consent of the female patient to participate in the trial

2. Healthy women aged 18 to 35 years in their 2nd and 3rd trimesters of pregnancy with gestational age of no more than 32 weeks

3. Singleton pregnancy progressing normally

4. No contraindications for vaccination

5. 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)

6. 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))

Exclusion Criteria

1. Body temperature above 37°С

2. History of influenza or previous influenza vaccination during 6 months before the screening

3. History of allergic reactions to chicken protein

4. Allergic reactions to vaccine components or any previous vaccination

5. Gestational toxicosis

6. Any disorders of pregnancy

7. Thyroid disorders

8. Bronchial asthma

9. Clotting disorders

10. 1, 2 type diabetes mellitus

11. 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

12. 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

13. 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)

14. Immunomodulatory therapy, including immune-enhancing, immunosuppressive therapy (corticosteroids, cytotoxic and radioactive drugs) in the 6 months preceding the trial

15. Any other contraindications against vaccination according to the investigator.

16. Leukemia, cancer or a positive reaction to HIV infection, hepatitis B and C, syphilis in the medical history

17. Volunteers who received immunoglobulin or blood products within the last three months before the trial

18. History of Guillain-Barré syndrome (acute polyneuropathy)

19. Autoimmune diseases

20. Any confirmed or suspected immunosuppressive or immunodeficiency condition

21. Respiratory, cardiovascular failure, impaired liver or kidney function.

22. Severe birth defects or serious chronic diseases, including any clinically significant chronic diseases of lungs, kidneys, cardiovascular, nervous system, psychiatric diseases or metabolic disorders, confirmed by medical history or objective examination

23. Vaccination with any vaccine less than 30 days before the screening or scheduled vaccination with any vaccine within 30 days from vaccination with the trial vaccines

24. The woman is/was a patient of a tuberculosis dispensary and/or narcological dispensary and/or neuropsychiatric dispensary

25. Chronic alcohol abuse and/or use of drugs in the past history

26. Smoking

27. Participation in another clinical trial during the last 3 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

St. Petersburg Research Institute of Vaccines and Sera

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ellina Ruzanova, PhD

Role: STUDY_DIRECTOR

St. Petersburg Research Institute of Vaccines and Sera

Locations

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

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

Seversk, Tomsk Oblast, Russia

"Curator" Limited Liability Company

Saint Petersburg, , Russia

KOROLEV MEDICINE Limited Liability Company

Saint Petersburg, , Russia

Municipal Budgetary Institution "Central City Hospital No.7"

Yekaterinburg, , Russia

Countries

Russia

Other Identifiers

FM-2019-01

Identifier Type: -

Identifier Source: org_study_id