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IRCT20201104049265N2 IRCT 2021-09-15 NIVAD Pharmed Salamat Safety evaluation of quadrivalent recombinant influenza vaccine (serotypes of 2021/2022), open label, single arm, in volunteers aged ≥ 18 years. Safety evaluation of a quadrivalent recombinant influenza vaccine (serotypes of 2021/2022) manufactured by Nivad Pharmed Salamat, open label, single arm, in volunteers aged ≥ 18 years. 2021-09-15 anticipated 1000 Complete https://irct.ir/trial/58647 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention. N/A Influenza due to certain identified influenza viruses. Intervention group: pre-filled syringe of Fluguard quadrivalent flu vaccine containing strains of 2021-2022, 45μg HA/ serotype/dose for intramuscular injection of 0.5 ml. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further plans
public Dr. Setayesh Sadeghi
West side of Sheikh Baha'i Square, Ryan Vanak Building, No. 18, 6th floor, Unit 603
Tehran Iran (Islamic Republic of) 1993873057 +98 21 8609 2794 s.sadeghi@artapharmed.com Arta Zist Pharmed scientific Dr. Mostafa Ghanei
Mollasadra Street
Tehran Iran (Islamic Republic of) 19945-581 +98 21 8860 0067 m.ghanei@bmsu.ac.ir Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Aged ≥ 18 years Able to provide written informed consent Subject is willing to comply with the study visits Healthy subjects or patients with stable concomitant diseases (the underlying disease is controlled and there is no need for hospitalization) 18 years no limit Both Subject is currently participating or is planning to participate in another clinical trial in 1 month Females of childbearing age with confirmed or suspected pregnancy, those planning on conceiving during the trial duration and women who are breastfeeding Fever at the time of entry (temperature > 38 measured by remote thermometer) Having an active infection with clinical signs of Covid-19 such as fever or chills, cough, fatigue, headache, shortness of breath, sore throat, change in sense of smell or taste, or any other warning signs of infection within 72 hours before injection (If a person has already had the disease and has recovered, participation in the study is not prohibited.) History of severe allergy to any type of vaccine (anaphylactic shock) History of Guillain-Barré or other demyelinating diseases Covid-19 vaccination at least 2 weeks before participation Planning to receive Covid-19 vaccine for at least the next 2 weeks according to the national vaccination protocol J09 J09 Prevention Intervention group: pre-filled syringe of Fluguard quadrivalent flu vaccine containing strains of 2021-2022, 45μg HA/ serotype/dose for intramuscular injection of 0.5 ml Number of participants with Solicited Local and Systemic Adverse Drug Reactions in the first 7 days after injection (days 0-6). Timepoint: days 0-6. Method of measurement: number of participants. Number of participants with Unsolicited Adverse Events in the first 7 days after injection (days 0-6). Timepoint: days 0-6. Method of measurement: number of participants. Number of participants with vasovagal syncope in the first 7 days after injection (day 0-6) based on VAERS. Timepoint: days 0-6. Method of measurement: number of participants. Number of participants with fever (any, Grade 3, related) in the first 7 days after injection (days 0-6). Timepoint: days 0-6. Method of measurement: number of participants. Unsolicited Adverse Events 7 to 14 days after vaccination. Timepoint: Days 7 to 14. Method of measurement: number of participants. Number of participants with Adverse Events of Special Interest (AESIs) 42 days after injection. Timepoint: Day 42. Method of measurement: number of participants. Number of participants with Medically Attended Adverse Events (MAEs) in 14 days after injection. Timepoint: days 0 to 14. Method of measurement: number of participants. Number of participants with SAEs. Timepoint: Throughout the study. Method of measurement: number of participants. Number of seroconverted subjects for Hemagglutination Inhibition Antibodies assay against 4 strains of influenza on day 28 after vaccination. Timepoint: day 28. Method of measurement: number of participants. NIVAD Pharmed Salamat Approved 2021-09-13 Iran National Committee for Ethics in Biomedical Research Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)