Seasonal flu vaccination. Influenza due to certain identified influenza viruses
Conditions
Interventions
Intervention 1: Intervention group: Pre-filled syringe of Fluguard seasonal flu vaccine (manufactured by Nivad Pharmed Salamat) 45 microgram HA per serotype per dose, intramuscular injection (non-dom
Sponsors
Nivad Pharmed Salamat
Eligibility
Sex/Gender
All
Age
9 Years to 18 Years
Inclusion criteria
Inclusion criteria: Age between 9-18 Have general health Sign informed consent for volunteers (over 14) Parents sign the informed consent form Be able to accompany with the visit programs and study process
Exclusion criteria
Exclusion criteria: History of previous vaccinations against influenza strains used in injectable vaccines during the new influenza season History of allergy to egg or Vaxigrip or Its components Any type of disease with evidence of acute viral respiratory infection Any conditions that prevent the study volunteer from enroll, such as: Thrombocytopenia (platelets less than 150,000), Coagulopathy, Receiving anticoagulants during last 3 months, Prohibition of IM drug administration, History of congenial or immunodeficiency or autoimmune disease, Acute phase of infectious disease, such as having a temperature of more than 37.7 °C during the 7 days before enrollment Receiving live attenuated vaccine within 30 days before enrollment Receiving immunomodulatory or immunosuppressant drugs, Receiving long-term systemic corticosteroid (corticosteroids for more than two weeks in the last 3 months or receiving prednisolone more than 2 mg/kg daily or its equivalent dose for more than 10 days) Receiving immunoglobulins and blood products within 3 months before enrollment History of Guillain-Barre syndrome Conditions such as neurological disorders and seizure under treatment (seizure history is not considered as exclusion criteria.) history of transplant, Cardiovascular disease, Asthma History of malignancies and radiotherapy during last 6 months Married women under the age of 18, pregnant or pregnancy planning in female volunteers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric Mean Ratio of antibody titer against hemagglutinin protein of species A H1N1 with GMT scale after 28 days compared to control group. Timepoint: Day zero and 28. Method of measurement: ELISA.;Geometric Mean Ratio of antibody titer against hemagglutinin protein of species A H13N2 with GMT scale after 28 days compared to control group. Timepoint: Day zero and 28. Method of measurement: ELISA.;Geometric Mean Ratio of antibody titer against hemagglutinin protein of species B Yamagata with GMT scale after 28 days compared to control group. Timepoint: Day zero and 28. Method of measurement: ELISA.;Geometric Mean Ratio of antibody titer against hemagglutinin protein of species B Victoria with GMT scale after 28 days compared to control group. Timepoint: Day zero and 28. Method of measurement: ELISA.;Seroconversion rate against hemagglutinin protein species A H1N1 after 28 days compared to control group. Timepoint: Day zero and 28. Method of measurement: ELISA.;Seroconversion rate against hemagglutinin protein species A H3N2 after 28 days compared to control group. Timepoint: Day zero and 28. Method of measurement: ELISA.;Seroconversion rate against hemagglutinin protein species B Yamagata after 28 days compared to control group. Timepoint: Day zero and 28. Method of measurement: ELISA.;Seroconversion rate against hemagglutinin protein species B Victoria after 28 days compared to control group. Timepoint: Day zero and 28. Method of measurement: ELISA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Seroconversion rate against hemagglutinin protein species A H1N1, A H3N2, B Yamagata and B Victoria after 28 days. Timepoint: Day zero and 28. Method of measurement: ELISA.;Number of volunteers with incidence of Immediate Adverse Drug Reactions. Timepoint: 1 and 24 hour after vaccination. Method of measurement: Direct observation and reporting.;Number of volunteers with incidence of Solicited Adverse Drug Reactions. Timepoint: Days zero to 6 after vaccination. Method of measurement: Direct observation and reporting.;Number of volunteers with incidence of Unsolicited Adverse Drug Reactions. Timepoint: Days zero to 6 after vaccination. Method of measurement: Direct observation and reporting.;Number of volunteers with incidence of Vasovagal syncope According to VAERS (Vaccine Adverse Event Reporting System). Timepoint: Days zero to 6 after vaccination. Method of measurement: Direct observation and reporting.;Number of volunteers with incidence of grade 3 fever related to vaccine. Timepoint: Days zero to 6 after vaccination. Method of measurement: Direct observation and reporting.;Number of volunteers with incidence of Unsolicited Adverse Drug Reactions. Timepoint: Days 7 to 28 after vaccination. Method of measurement: Direct observation and reporting.;Number of volunteers with incidence of Serious Adverse Events (SAEs). Timepoint: Up to 6 months after vaccination. Method of measurement: Direct observation and reporting.;Number of volunteers with incidence of Delayed Adverse Events. Timepoint: From 1 to 6 months after vaccination. Method of measurement: Direct observation and reporting. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Setayesh Sadeghi
CaRO Pharmed Alborz
Outcome results
None listed