Safety, Reactogenicity, Immunogenicity, Efficacy of Influenza Vaccines Grippol® Quadri and Grippol® Plus in Volunteers

Inclusion Criteria

• Signed and dated volunteer's informed consent for participation in the study.
• Men and women from 18 to 60 years old.
• Healthy volunteers without signs of acute or chronic disorders, without history of chronic respiratory, cardiovascular, nervous system disorders, hepatic or renal disorders.
• Previously not immunized, or previous influenza immunization occurring ≥ 12 months before this study.
• Subjects without history of influenza within ≥ 12 months before this study.
• Consent of volunteers (men and women) to use adequate methods of contraception (cervical caps with spermicide, diaphragms with spermicide, condoms with spermicide, intrauterine devices, oral contraceptives) or full abstinence for the whole period of the study.

Specific:

• Contraindications listed in the protocol and prescribing information for inactivated influenza vaccines:
• acute infections and non-communicable disorders, including the period of reconvalescence of at least one month from the time of clinical and laboratory evidence of recovery;
• hepatitis or meningococcal infection occurred less than 6 months after recovery;
• exacerbations of chronic disorder or decompensated disorders that may impact the study (organic central nervous system disorders, decompensated cardiovascular disorder, acute renal or hepatic failure);
• malignant neoplasms (including hematological disorders);
• primary immunodeficiency (laboratory-confirmed);
• HIV infection or HIV-associated disorders;
• systemic disorders of connective tissue;
• haemophilia (and other blood coagulation disorders);
• severe neurological disorders;
• Guillain-Barré syndrome (post infection demyelinating polyradiculoneuropathy of autoimmune nature with peripheral limb muscle palsy related to inflammation and destruction of myelin sheath of peripheral nerves; may acquire an ascending nature, involving muscles of face, pharynx, larynx);
• history of severe vaccine-associated reactions (body temperature exceeding 38.5 °С) or local reactions (hyperemia and/or oedema at the site of injection of over 5 cm in diameter);
• history of severe allergic disorders (angioedema, polymorphic exudative erythema, serum disease, etc.);
• hypersensitivity to chicken protein or vaccine components;
• blood and components transfusion within the last 6 months.
• Indications for immunomodulating therapy.
• Body temperature over 37.0 °С at screening or before injection.
• Potential evidence of a chronic infection (periodic episodes of fever within the last 6 months), or antiviral (and/or antibacterial) treatment indicated.
• History of disorders or conditions, which, according to investigator's judgment may impact the thermal regulation (chronic infections, neuroendocrine disorders [thyrotoxicosis, pheochromocytoma, etc.], climacteric syndrome, malignant hyperthermia, diseases of the central nervous system, malignant neoplasm, connective tissue disorders, systemic vasculitis, and information on excessive physical stress or work-rest regimen deviations [within the last 2 months: night shifts, significant change of time zones, overheating]).
• Use of antipyretics (including non-steroidal anti-inflammatory drugs and anilides) within 24 hours before randomization.
• Surgical interventions within less than 90 days before the screening visit.
• Systolic blood pressure of over 130 mm Hg or less than 100 mm Hg and/or diastolic blood pressure of over 90 mm Hg or less than 60 mm Hg.
• Any other disorder, which, in the opinion of the investigator, may prevent inclusion of the volunteer due to safety reasons or may impact the study results.

General:

• Pregnant and nursing women.
• Lack of ability to visit daytime inpatient facility according to the study schedule, unavailability for adequate follow-up of the volunteer.
• Body mass index of less than 18.5 or over 30.0 kg/m2 based on the weight-height Quetelet's index.
• Participation in another clinical study of medicinal drugs within 3