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
- Conditions
- Seasonal Influenza.Influenza due to certain identified influenza viruses
- Registration Number
- IRCT20080901001165N61
- Lead Sponsor
- iwad-Pharmed-Salamat company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 200
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.
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method