the objectives of this study are study the immunogenicity and safety of the flu-m [inactivated split influenza vaccine], vs. the ultrix® inactivated split influenza vaccine, in volunteers who are over 60 years old

Conditions: Influenza

Summary: this trial by its design was a prospective, multicenter, double blind, randomized comparative clinical trial of the iiib-iv phase which was carried out in parallel groups of volunteers over the age of 60

the volunteers will include in the trial will divide into two groups: group 1: volunteers who will receive one dose of flu-m, solution for intramuscular injection, 0.5 ml, intramuscularly. group 2: volunteers who will receive one dose of ultrix®, solution for intramuscular administration, 0.5 ml, intramuscularly. the trial include the following periods and visits: 1. screening period (up to 7 days): • visit 0 (day -7...-1). 2. vaccination period (up to 1 day): • visit 1 (day 1, randomization, blood collection for serological examination, vaccination). 3. follow-up period (up to 28(+2) days): * visit 2 (day 3, organization of trials to assess safety); * visit 3 (day 7(+1), organization of trials to assess safety); * visit 4 (day 21(+2), organization of trials to assess safety, blood collection for serological study); * visit 5 (day 28(+2), organization of trials to assess safety, trial completion);

Eligibility criteria:
inclusion criteria: * presence of signed informed consent to participate in the trial. * volunteers (both male and female) over the age of 60 who could meet the protocol requirements. * negative pregnancy test obtained from female volunteers with preserved childbearing potential. * consent to use adequate contraception methods (contraception methods with degree of reliability of more than 90%: a nonhormonal intrauterine device; a spermicide condom; a spermicide cervical cap; spermicide diaphragms) or total sexual abstinence during the clinical trial (until visit 5 (day 28(+2)). exclusion criteria: * allergic reactions to chicken protein or any previous influenza vaccination. * anamnestic data on the episodes of severe allergic reactions and/or diseases (anaphylaxis, quincke's edema, polymorphic exudative erythema, serum disease etc.) * acute reaction (temperature above 38.5ос, edema and hyperemia over 5 cm in diameter at the injection site) or complications caused by previous administration of the drug. * previous vaccination 6 months before the start of the trial. * history of leucosis, blood cancer, malignant oncological diseases. * guillain-barré syndrome (acute polyneuropathy) in the medical history. * positive screening for hiv infection, b and c hepatitis, syphilis. * any confirmed or suspected immunosuppressive or immunodeficiency condition; * administration of immunoglobulin or blood products within the last three months before the study. * long-term use (more than 14 days) of immunosuppressants (including systemic corticosteroids, cytotoxic, radioactive preparations) or other immunomodulatory drugs for six months before the trial. * chronic diseases at the decompensation stage or in debilitating form, which can make it dangerous for the volunteer to take part in the trial. * progressive neurological disorders, dementia. * blood disorders which serve as a contradiction for intramuscular injection. * history of alcohol or drug addiction. * pregnancy, breastfeeding in women with preserved reproductive performance. * current participation in another clinical trial or within the previous 3 months before the screening. * mental, physical and other problems which do not allow for appropriate assessment of own behavior and following the requirements set out in the trial protocol. * any other conditions which in the reasonable opinion of the clinical investigator complicate the participation of the volunteer in the trial

Keywords: influenza flu vaccine flu-m