IRCT20080901001165N61
Not yet recruiting
Phase 3
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
iwad-Pharmed-Salamat company0 sites200 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- iwad-Pharmed-Salamat company
- Enrollment
- 200
- Status
- Not yet recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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;
Outcomes
Primary Outcomes
Not specified
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