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IRCT20080901001165N61 IRCT 2020-06-12 Niwad-Pharmed-Salamat company Investigating the comparative preventive efficacy and safety of FluGaurd® (a 4-valent recombinant influenza vaccine, produced by Niwad-Pharmed-Salamat company, I.R.Iran), to Vaxigrip® (produced by Sanofi company, France) as the reference product in Healthy volunteers Investigating the comparative preventive efficacy and safety of FluGaurd® (a 4-valent recombinant influenza vaccine, produced by Niwad-Pharmed-Salamat company, I.R.Iran), to Vaxigrip® (produced by Sanofi company, France) as the reference product in Healthy volunteers 2020-08-22 anticipated 200 Complete https://irct.ir/trial/48628 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Block Randomization method is used to randomized the patients. For randomization, we visited the www.sealedenvelope.com, then randomization tab and make a list option were selected, the number of intervention groups, sample size, block size (which was selected due to the small sample size, 4 )were entered the intended locations, then a random list containing the pattern of patient allocation was obtained in two intervention, Blinding description: The study will be done as a double blind RCT. The Vaxigrip vaccine, in a very similar appearance to the Flugaurd vaccine, will be given to the main researcher by the Flugaurd's manufacturer , and the drug and control are distinguished only by the code that only the main researcher is aware of. Prescribers and volunteers will be unaware of the drug / product control. The results will be recorded in the checklist based on the code registered on the drug and the analysis will be done based on the codes. At the end of the study, the meaning of each code will be determined. 3 Seasonal Influenza. Intervention 1: Intervention group: Pre-filled syringe of Flugaurd (the seasonal influenza vaccine, manufactured by Newad Farmad Salamat), 45 mg HA/serotype/dose, intramuscular injection (non-dominant hand deltoid muscle) in the amount of 0.5 ml in the first visit. Intervention 2: Control group: Pre-filled syringe of Vaxigrip ( the seasonal influenza vaccine, manufactured by Sanofi), 45 mg HA / serotype / dose, intramuscular injection (non-dominant hand deltoid muscle) in the amount of 0.5 ml in the first visit. 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 The release schedule is not clear yet.
public Nematollah Jonaidi
Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8245 5393 jonaidi2000@yahoo.com Bagheiat-allah University of Medical Sciences scientific Yunes Panahi
Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8245 5393 Yunespanahi@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) The age of the volunteer is between 18 and 49 years. The volunteer has general health (through clinical examinations and medical records). The volunteer or his/her legal guardian must have signed the informed consent form. The volunteer must be able to keep up with the monitoring programs. 18 years 49 years Both Have a history of previous vaccinations against influenza strains used in injectable vaccines; Have a history of allergy to Vaxigrip; History of chronic use (more than 14 days) immunosuppressive drugs in the last 6 months (in the case of corticosteroids, prednisolone (or its equivalents) in the amount of 0.5 mg per kg of volunteer weight per day. Topical or inhaled steroids usage are free.) History of any immune system disorders such as Guillain-Barré syndrome and other Masculoscletal disorders; History of chronic diseases such as cancer, liver and kidney disease, neurological disorders, diabetes; History of receiving immunoglobulins or other blood products 90 days before the vaccine injection; Pregnancy; Lactation. J09 Influenza due to certain identified influenza viruses Prevention Prevention Intervention group: Pre-filled syringe of Flugaurd (the seasonal influenza vaccine, manufactured by Newad Farmad Salamat), 45 mg HA/serotype/dose, intramuscular injection (non-dominant hand deltoid muscle) in the amount of 0.5 ml in the first visit Control group: Pre-filled syringe of Vaxigrip ( the seasonal influenza vaccine, manufactured by Sanofi), 45 mg HA / serotype / dose, intramuscular injection (non-dominant hand deltoid muscle) in the amount of 0.5 ml in the first visit The ratio of antibody titer against hemagglutinin protein type A H1N1 with GMT scale compared to the control group at day 28 days;. Timepoint: At the baseline, then on day 28. Method of measurement: Blood sampling. The ratio of antibody titer against hemagglutinin protein type A H3N2 with GMT scale compared to the control group at day 28 days;. Timepoint: At the baseline, then on day 28. Method of measurement: Blood sampling. The ratio of antibody titer against hemagglutinin protein type B Yamagata with GMT scale compared to the control group at day 28 days;. Timepoint: At the baseline, then on day 28. Method of measurement: Blood sampling. The ratio of antibody titer against hemagglutinin protein type B Victoria with GMT scale compared to the control group at day 28 days;. Timepoint: At the baseline, then on day 28. Method of measurement: Blood sampling. Seroconversion rate difference against hemagglutinin protein type A H1N1 after 28 days compared to the control group;. Timepoint: At the baseline, then on day 28. Method of measurement: Blood sampling. Seroconversion rate difference against hemagglutinin protein type A H3N2 after 28 days compared to the control group;. Timepoint: At the baseline, then on day 28. Method of measurement: Blood sampling. Seroconversion rate difference against hemagglutinin protein type B Yamagata after 28 days compared to the control group;. Timepoint: At the baseline, then on day 28. Method of measurement: Blood sampling. Seroconversion rate difference against hemagglutinin protein type B Victoria after 28 days compared to the control group;. Timepoint: At the baseline, then on day 28. Method of measurement: Blood sampling. The rate of occurrence of any local or systemic solicited complication;. Timepoint: Daily (from day 0 till the end of day 6). Method of measurement: Monitoring by phone. The rate of occurrence of any unsolicited complication;. Timepoint: Daily. Method of measurement: Monitoring by phone. The occurrence rate of any serious side adverse effect;. Timepoint: Daily. Method of measurement: Monitoring by phone. Seroconversion rate against A H1N1 hemagglutinin protein after 28 days;. Timepoint: Baseline, then at day 28. Method of measurement: Blood sample. Seroconversion rate against A H3N2 hemagglutinin protein after 28 days;. Timepoint: Baseline, then at day 28. Method of measurement: Blood sample. Seroconversion rate against B Yamagata hemagglutinin protein after 28 days;. Timepoint: Baseline, then at day 28. Method of measurement: Blood sample. Seroconversion rate against B Victoria hemagglutinin protein after 28 days;. Timepoint: Baseline, then at day 28. Method of measurement: Blood sample. Seroprotection rate against َA H1N1 hemagglutinin protein after 28 days;. Timepoint: Baseline, then at day 28. Method of measurement: Blood sample. Seroprotection rate against َA H3N2 hemagglutinin protein after 28 days;. Timepoint: Baseline, then at day 28. Method of measurement: Blood sample. Seroprotection rate against َB Yamagata hemagglutinin protein after 28 days;. Timepoint: Baseline, then at day 28. Method of measurement: Blood sample. Seroprotection rate against َB Victoria hemagglutinin protein after 28 days;. Timepoint: Baseline, then at day 28. Method of measurement: Blood sample. Changes in biochemistry and hematologic parameters (Sr Cr، BUN، ALT، AST، Bilirubin total & direct، CBC diff، Platelet،CD4, CD8, IgM, IgG INR، PTT، PT). Timepoint: Baseline, then at day 28. Method of measurement: Laboratory analysis of blood sample. Changes in Tumor Necrotizing Factor(TNF)-alfa serum level;. Timepoint: Baseline, then at day 28. Method of measurement: Elisa Kit. Changes in Interleukin-1 serum level;. Timepoint: Baseline, then at day 28. Method of measurement: Elisa Kit. Changes in Interleukin-6 serum level;. Timepoint: Baseline, then at day 28. Method of measurement: Elisa Kit. Niwad-Pharmed-Salamat company Approved 2020-05-16 Ethics committee of Baqiyatallah Medical Sciences University Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)