Seasonal flu. Influenza due to other identified influenza virus with other respiratory manifestations
Conditions
Sponsors
Nivad Pharmed Salamat Co.
Eligibility
Sex/Gender
All
Age
9 Years to 18 Years
Inclusion criteria
Inclusion criteria: Age 9-18 years People with general health (through clinical examinations and medical records) Providing informed and voluntary written consent for participation in the study by subjects = 14 y/o Providing informed and voluntary written consent for participation in the study by the parents of subjects Ability to accompany the visits and the study follow-up
Exclusion criteria
Exclusion criteria: History of vaccination against influenza strains used in the study vaccine, within 6 months before the start of the study History of allergy to eggs or vaxigrip vaccine or its components Any illness with evidence of acute viral respiratory infection Thrombocytopenia (platelets < 150,000) Coagulation disorders Receiving anticoagulant during the last 3 months The impossibility of administering drugs intramuscularly Congenital or acquired diseases indicating immune system defects or autoimmune diseases Acute phase of infectious disease, such as having an oral temperature of more than 37.7oC during the 7 days before the start of the study Receiving live attenuated vaccine within 30 days prior to study entry Receiving immunomodulatory or immunosuppressant drugs, or long-term use of systemic corticosteroids (defined as receiving prednisolone at a dose of 2 mg/kg/day or an equivalent dose for more than 10 days in the past 3 months) Receiving immunoglobulins and blood products within 3 months before the start of the study History of Guillain-Barré syndrome Conditions such as neurological disorders and under treatment seizures (Except the history of seizures) Organ transplantation, cardiovascular diseases, and asthma History of malignancies and radiotherapy during the past 6 months Married women under the age of 18, pregnant or planning to become pregnant in female volunteers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean ratio of antibody titer against hemagglutinin protein of type A H1N1 with GMT scale after 28 days compared to control group. Timepoint: Day 28. Method of measurement: Hemagglutination Inhibition.;Geometric mean ratio of antibody titer against hemagglutinin protein of type A H3N2 with GMT scale after 28 days compared to control group. Timepoint: Day 28. Method of measurement: Hemagglutination Inhibition.;Geometric mean ratio of antibody titer againsthemagglutinin protein of type B Yamagata with GMTscale after 28 days compared to control group. Timepoint: Day 28. Method of measurement: Hemagglutination Inhibition.;Geometric mean ratio of antibody titer against hemagglutinin protein of type B Victoria with GMT scale after 28 days compared to control group. Timepoint: Day 28. Method of measurement: Hemagglutination Inhibition.;Seroconversion rate against hemagglutinin protein of type A H1N1 after 28 days compared to control group. Timepoint: Day 0, Day 28. Method of measurement: Hemagglutination Inhibition.;Seroconversion rate against hemagglutinin protein of type A H3N2 after 28 days compared to control group. Timepoint: Day 0, Day 28. Method of measurement: Hemagglutination Inhibitio.;Seroconversion rate against hemagglutinin protein of type B Yamagata after 28 days compared to control group. Timepoint: Day 0, Day 28. Method of measurement: Hemagglutination Inhibition.;Seroconversion rate against hemagglutinin protein of type B Victoria after 28 days compared to control group. Timepoint: Day 0, Day 28. Method of measurement: Hemagglutination Inhibition. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with seroconversion against the hemagglutinin protein of types A H1N1, A H3N2, B Yamagata and B Victoria after 28 days in both groups. Timepoint: Day 0, Day 28. Method of measurement: Hemagglutination Inhibition.;Proportion of subjects with HI antibody serum titer = 1:40 (% = 1:40) against A H1N1, A H3N2, B Yamagata and B Victoria types after 28 days in both groups. Timepoint: Day 28. Method of measurement: Hemagglutination Inhibition.;Number of subjects with Immediate Adverse Drug Reactions in an hour following vaccination. Timepoint: Day 0. Method of measurement: Reported Immediate Adverse Drug Reactions.;Number of subjects with Solicited Adverse Drug Reactions during 7 days post vaccination. Timepoint: Day 0 to 7. Method of measurement: Number of reprted Solicited Adverse Drug Reactions in diary cards or call center.;Number of subjects with Unsolicited Adverse Drug Reactions during 7 days post vaccination. Timepoint: Day 0 to 7. Method of measurement: Reprted Unsolicited Adverse Drug Reactions in diary cards or call center.;Number of subjects with vasovagal syncope during 7 days post vaccination according to VAERS. Timepoint: Day 0 to 7. Method of measurement: Reported vasovagal syncope in diary cards or call center with principal investigator approval.;Number of subject with garde 3 fever related to vaccination during 7 days post vaccination. Timepoint: Day 0 to 7. Method of measurement: Reported fever with grade 3 (above 39 degree of centigrade) and related to vaccination in diary cards or call center.;Number of subjects with Unsolicited Adverse Drug Reqactions during day 7 until 28 following vaccination. Timepoint: Day 7 to 28. Method of measurement: Reprted Unsolicited Adverse Drug Reactions in diary cards or call center.;Number of subjects with Adverse Events of Special Interest (AESIs) 3 months following vaccination. Timepoint: Day 0 to 90. Method of measurement: Reported AESIs in diary cards or call center with principal investigator | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Hamidreza Kafi
Orchid Pharmed Co.
Outcome results
None listed