Influenza due to certain identified influenza viruses. J09
Conditions
Interventions
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.
Sponsors
NIVAD Pharmed Salamat
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Setayesh Sadeghi
Arta Zist Pharmed
Outcome results
None listed