Seasonal Influenza. Influenza due to certain identified influenza viruses
Conditions
Interventions
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
Sponsors
Niwad-Pharmed-Salamat company
Eligibility
Sex/Gender
All
Age
18 Years to 49 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Inte | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNematollah Jonaidi
Bagheiat-allah University of Medical Sciences
Outcome results
None listed