Trial of the Reactogenicity, Safety and Immunogenicity of the Flu-M Vaccine Manufactured by FSUE SPbSRIVS FMBA

Influenza Clinical Trial

Official title:

Trial of the Reactogenicity, Safety and Immunogenicity of the Flu-M Vaccine Manufactured by FSUE SPbSRIVS FMBA vs. the Vaxigrip® Inactivated Influenza Split Vaccine Manufactured by Sanofi Pasteur, France, in Volunteers Aged 18-60 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05297994
• Other study ID #: FMV-VGIR-II-001/16
• Status: Completed
• Phase: Phase 2
• Start date: October 24, 2016
• Est. completion date: March 9, 2017

Study information

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

Clinical Trial Summary

To trial the reactogenicity, safety and immunogenicity of the Flu-M inactivated split influenza vaccine in volunteers aged 18-60 years

Description:

All subjects will be followed up for 21 days post-randomization. The subjects will further be assessed at 2 days, 7 days, 21 days following the booster vaccination. Blood samples will be collected for reactogenicity and safety and immunogenicity assessments before injection and 21 days after vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 9, 2017
• Est. primary completion date: December 12, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Written informed consent of the volunteers to participate in the clinical trial;
• Healthy volunteers (men and women) aged 18-60 years;
• Volunteers able to fulfill requirements of the protocol (fill out the patient's diary, come to follow-up visits);
• If the participant is female, she was required to have negative pregnancy test results and use contraceptives throughout the follow-up period (complete contraception of women of reproductive period)

Exclusion Criteria:

• Allergic reactions to chicken protein or any previous influenza vaccination;
• Leukemia, cancer or a positive reaction to human immunodeficiency virus infection, hepatitis B and C, syphilis in the past medical history;
• Volunteers who received immunoglobulin or blood products within the last 3 months before the trial;
• Guillain-Barré syndrome (acute polyneuropathy) in the medical history;
• Long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs for 6 months prior to the trial.
• Any confirmed or suspected immunosuppressive or immunodeficiency condition;
• Respiratory, cardiovascular failure, impaired liver or kidney function found during a physical examination or laboratory tests during Visit 1;
• 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;
• Being (or having been) a patient of a tuberculosis dispensary and/or narcological dispensary and/or neuropsychiatric dispensary;
• acute infectious and/or non-infectious diseases at the time of inclusion in the trial;
• Exacerbation of chronic diseases;
• chronic alcohol abuse and/or use of drugs in the past history;
• Pregnancy and lactation;
• Participation in another clinical trial within the last 3 months;
• Immunization with influenza vaccines in the last 6 months

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Flu-M [Inactivated split influenza vaccine]
solution for intramuscular injection, 0.5 ml
• Inactivated influenza split vaccine
solution for intramuscular injection, 0.5 ml

Locations

Country	Name	City	State
Russian Federation	Infection Center	Novosibirsk
Russian Federation	Perm State Medical University named after Academician E. A. Wagner	Perm
Russian Federation	Research Institute of Influenza	Saint Petersburg

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	Severity of observed local reactions and their relationship with the vaccination	% of patients with: • Pain at the injection site at pressing Measurement tool: 4-point scale: 0 - none, 1 - mild, 2 - moderate, 3 - severe. Unit of measure: % of symptomatic patients at each severity	days 1-21 post-vaccination
Primary	Severity of observed local reactions and their relationship with the vaccination	% of patients with: • Hyperemia; Measurement tool: 4-point scale: 0 - none, 1 - mild, 2 - moderate, 3 - severe. Unit of measure: % of symptomatic patients at each severity	days 1-21 post-vaccination
Primary	Severity of observed local reactions and their relationship with the vaccination	% of patients with: • Infiltrate Measurement tool: 4-point scale: 0 - none, 1 - mild, 2 - moderate, 3 - severe. Unit of measure: % of symptomatic patients at each severity	days 1-21 post-vaccination
Primary	Severity of observed local reactions and their relationship with the vaccination	% of patients with: • Swelling Measurement tool: 4-point scale: 0 - none, 1 - mild, 2 - moderate, 3 - severe. Unit of measure: % of symptomatic patients at each severity	days 1-21 post-vaccination
Primary	Severity of observed system reactions and their relationship with the vaccination	% of patients with: • Fever Measurement tool: 4-point scale: 0 - none (= 37°?), 1 - mild (> 37°? - = 37.5°?), 2 - moderate (> 37.6°? - = 38.5°?), 3 - severe (> 38.6°?).; Unit of measure: % of symptomatic patients at each severity	days 1-21 post-vaccination
Primary	Severity of observed system reactions and their relationship with the vaccination	% of patients with: • Chills Measurement tool: 4-point scale: 0 - none, 1 - mild, 2 - moderate, 3 - severe. Unit of measure: % of symptomatic patients at each severity	days 1-21 post-vaccination
Primary	Severity of observed system reactions and their relationship with the vaccination	% of patients with: • Increased sweating Measurement tool: 4-point scale: 0 - none, 1 - mild, 2 - moderate, 3 - severe. Unit of measure: % of symptomatic patients at each severity	days 1-21 post-vaccination
Primary	Results of assessment of heart rate (HR)	The measurement of HR at each visit of the trial site by the volunteer	days 1-21 post-vaccination
Primary	Results of assessment of systolic and diastolic blood pressure (BP)	The measurement of systolic and diastolic BP at each visit of the trial site by the volunteer	days 1-21 post-vaccination
Primary	Results of biochemical blood tests	ALT (U/L); AST (U/L); Alkaline phosphatase (U/L)	days 3, 7 and 21
Primary	Results of biochemical blood tests	Bilirubin total (µmol/l)	days 3, 7 and 21
Primary	Results of biochemical blood tests	Total protein (g/l)	days 3, 7 and 21
Primary	Results of biochemical blood tests	C-reactive protein (mg/l)	days 3, 7 and 21
Primary	Results of biochemical blood tests	Urea (mmol/l); Glucose (mmol/l); Creatinine (mmol/l)	days 3, 7 and 21
Primary	Results of complete blood counts	Erythrocytes (10^12/L)	days 3, 7 and 21
Primary	Results of complete blood counts	Hemoglobin (g/L)	days 3, 7 and 21
Primary	Results of complete blood counts	Erythrocyte sedimentation reaction (ESR) (mm/h)	days 3, 7 and 21
Primary	Results of complete blood counts	Leukocytes, (? 10^9/L); Leukocytic formula: Stab neutrophils, % Segmented neutrophils (%) Eosinophils, (%) Basophils, (%) Lymphocytes, (%) Monocytes, (%)	days 3, 7 and 21
Primary	Results of complete blood counts	Platelets, (? 10^9/L)	days 3, 7 and 21
Primary	Incidence of AEs associated with the vaccination		days 1-21 post-vaccination
Primary	Incidence of SAEs associated with the vaccination		days 1-21 post-vaccination