Influenza. Influenza due to certain identified influenza virus
Conditions
Interventions
Intervention 1: Intervention group 1: 35 healthy individuals between the ages 18 to 65
injection of one dose of Flupak seasonal Influenza vaccine. Intervention 2: Intervention group2: 35 healthy persons between the ages 18 to 65
injection of one dose of Vaxigrip Influenza vaccine. Intervention 3: Control group: 30 healthy persons between the ages 18 to 65
injection of 0.5 mili liter of sterile and injectable Phosphate buffered saline (1x).
Prevention
Placebo
Intervention group 1: 35 healthy individuals between the ages 18 to 65
injection of one dose of Flupak seasonal Influenza vaccine.
Intervention group2: 35 healthy persons between the ages 18 to 65
injection of one dose of Vaxigrip Influenza vaccine.
Control group: 30 healthy persons between the ages 18 to 65
injection of 0.5 mili liter of sterile and injectable Phosphate buffered saline (1x)
Sponsors
Bayerpaul Fanavar Knowledge-based Company (LTD) is the financial sponsor and the registration number
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: healthy adults between 18 to 65 years old, both sexes; signing the consent form by participants; being healthy (as determined by vital signs and medical history); if the subject is female and of child bearing potential, negative urine or serum pregnancy test is necessary, she must use an acceptable contraception method and doesn't become pregnant during of the study; being able to understand and comply with planned study procedures; signing informed consent prior to initiation of study procedures; absence of existence of any exclusion criteria. Exclusion Criteria: known allergy to eggs or other components of vaccine (such as: formaldehyde and octoxinol-9); history of Guillain-Barre syndrome; pregnancy or positive pregnancy test prior to vaccination; breast feeding; immunosuppressive therapy in preceding 36 months; active neoplasm ( requiring any form of anti neoplastic therapy); psychiatric illness and /or concomitant psychiatric drug therapy; immunoglobulin ( or similar blood product) therapy within 3 months prior to vaccination; vaccine therapy within 4 weeks of study; influenza vaccine within 6 months of study; chronic illness that, in the opinion of investigator, may interfere with the evaluation of the immune response; documented HIV, HBV or HCV infection; acute febrile respiratory illness within one week of vaccination; experimental drug therapy within one month prior to vaccination; alcohol or drug abuse.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase of Specified antibody titer. Timepoint: Blood samples will be taken to test at day 0 and at day 21 to 28 after intrvention. Method of measurement: Serology test.;Fever more than 38 centigrade degree for 24 hours or more. Timepoint: Daily up to 3 days after intervention, once between days 21 to 28 after intervention beginning. Method of measurement: Centigrade degree label, by using thermometer, will be measured by doctor.;Headache. Timepoint: Daily up to 3 days after intervention, once between days 21 to 28 after intervention beginning. Method of measurement: Clinical check up by doctor.;Malaise. Timepoint: Daily up to 3 days after intervention, once between days 21 to 28 after intervention beginning. Method of measurement: Clinical check up by doctor.;Swelling and inflammtion at the injection site with diameter more than 50 mm which lasts. Timepoint: Daily up to 3 days after intervention, once between days 21 to 28 after intervention beginning. Method of measurement: Clinical check up by doctor. | — |
Secondary
| Measure | Time frame |
|---|---|
| Local redness at the injection site. Timepoint: Daily up to the 3 days after intervention. Method of measurement: Clinical check up by doctor.;Clinical changes in physical status of lungs. Timepoint: Daily up to the 3 days after intervention, once within days 21 to 28 after intervention. Method of measurement: Clinical check up by doctor.;Clinical changes in physical status of skin. Timepoint: Daily up to the 3 days after intervention, once within days 21 to 28 after intervention. Method of measurement: Clinical check up by doctor.;Heart rate. Timepoint: Daily up to the 3 days after intervention, once within days 21 to 28 after intervention. Method of measurement: Clinical check up by doctor.;Blood pressure. Timepoint: Daily up to the 3 days after intervention, once within days 21 to 28 after intervention. Method of measurement: Mercury manometers.;Analyphactic shock. Timepoint: Immediately after intervention. Method of measurement: Clinical check up by doctor.;Local pain at the injection site. Timepoint: Daily up to the 3 days after intervention. Method of measurement: Clinical check up by doctor.;Change in mucous membranes. Timepoint: Daily up to the 3 days after intervention, once within days 21 to 28 after intervention. Method of measurement: Clinical check up by doctor.;Local edema at injection site. Timepoint: Daily up to the 3 days after intervention. Method of measurement: Clinical check up by doctor.;Clinically significant changes in physical status of nervous system. Timepoint: Daily up to the 3 days after intervention, once within days 21 to 28 after intervention. Method of measurement: Clinical check up by doctor.;Local warmth at injection site. Timepoint: Daily up to the 3 days after intervention. Method of measurement: Clinical check up by doctor. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Yunes Panahi
Baqiyatallah University of Medical Sciences
Outcome results
None listed