The Objectives of This Study Are Study the Safety, Reactogenicity and Obtain Preliminary Data on the Immunogenicity of Flu-M Quadro, 4-valent Inactivated Split Influenza Vaccine, in Healthy Volunteers

Influenza Clinical Trial

Official title:

Phase I Simple Blind, Placebo Controlled, Randomized Safety and Reactogenicity Trial of the Flu-M Quadro Tetravalent Inactivated Split Influenza Vaccine, Solution for Intramuscular Injection, Produced by FSUE SPbSRIVS FMBA, vs. Placebo in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05152017
• Other study ID #: FMVq-I-001/18
• Status: Completed
• Phase: Phase 1
• Start date: November 16, 2019
• Est. completion date: January 24, 2020

Study information

• Verified date: November 2021
• Source: St. Petersburg Research Institute of Vaccines and Sera
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study the safety, reactogenicity and obtain preliminary data on the immunogenicity of Flu-M Quadro, 4-valent inactivated split influenza vaccine, in healthy volunteers

Description:

The maximum period of the volunteers' participation in the trial will be 35 ± 2 days. Screening period - up to 7 days. The vaccine administration period is 1 day. Follow-up period

• 28±2 days.

All volunteers are followed by a clinical investigator for 6 months after vaccination outside of this trial with the aim of detecting possible late adverse reactions. If a volunteer has any delayed-type reactions, the volunteer will be invited to the clinic for correction of his/her condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 24, 2020
• Est. primary completion date: January 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Voluntarily and personally signed form of informed consent for participation in the trial, before any trial procedure is carried out.

• Verified diagnosis "healthy", at that the clinical investigator shall confirm the absence of pathology on the part of the main organs and systems, previously conducted standard clinical, laboratory and instrumental studies did not reveal any diseases.

• Age between 18 and 60 years old, inclusively.

• Ability to attend all planned visits and all scheduled procedures and studies.

• Willingness of the volunteers to complete Self-Observation Diaries in between their visits to a clinical center.

• Previous vaccination against seasonal influenza at least 9 months prior to inclusion in this trial.

• Consent of the volunteers to use effective contraception methods contraception throughout the trial, including the term of observation for possible post-vaccination reactions

Exclusion Criteria:

• Known hypersensitivity to any of the components of the tested products, as well as to chicken meat or chicken/quail eggs.

• Allergic reaction to any previous influenza vaccination.

• Adverse reaction of severe degree of manifestation or serious adverse reaction to previous influenza vaccine administration.

• Signs of any disease at the time of inclusion in the trial or if less than 4 weeks have expired after recovery.

• Any acute respiratory disease less than 3 months before inclusion in the trial.

• Guillain-Barré syndrome (acute polyneuropathy) in the medical history.

• History of leukemia, tuberculosis, cancer, autoimmune diseases.

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

• Long-term use (exceeding 14 days) of immunosuppressants, systemic corticosteroids or immunomodulatory agents within 6 months before the trial

• Vaccination with any vaccine within one month before the vaccination.

• Acute infectious or non-communicable diseases, acute exacerbation of a chronic diseases within 4 weeks before the screening.

• Scheduled use of vaccines not provided by the tested protocol within 30 days (inclusively) after the vaccination.

• Pregnant and breastfeeding women.

• Positive blood test results for HIV, syphilis, hepatitis B/C.

• Participation in another clinical trial within 30 days before the screening visit or in parallel with the current trial.

• History of alcohol addiction, drug addiction or abuse of pharmaceutical products.

• Inability or inability to meet the requirements of the protocol, inter lia, for physical, mental or social reasons, according to the clinical investigator

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Flu-M Quadro [inactivated split influenza vaccine] with preservative
solution for intramuscular injection, 0.5 ml
• Flu-M Quadro [inactivated split influenza vaccine] without preservative
solution for intramuscular injection, 0.5 ml
• Placebo
solution for intramuscular injection, 0.5 ml

Locations

Country	Name	City	State
Russian Federation	Federally Funded Healthcare Institution Primary Healthcare Unit No. 163	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
St. Petersburg Research Institute of Vaccines and Sera

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (local and systemic post-vaccination reactions)		days 1-7
Primary	Incidence of adverse events (systemic post-vaccination reactions)		days 1-7
Primary	Incidence of any serious adverse events during the trial		days 1-28
Secondary	The content of specific anti-influenza antibodies in serum		days 0, 28 after the vaccination
Secondary	The geometric mean titer (GMT) of antibodies to hemagglutinins of the influenza virus		days 0, 28 after the vaccination
Secondary	Seroconversion factor	It shout be more than 2.5 after the vaccination	days 0, 28
Secondary	Seroconversion level		days 0, 28 after the vaccination
Secondary	Seroprotection level		days 0, 28 after the vaccination