Evaluation of the immunogenicity and safety of quadrivalent seasonal flu vaccine named Fluguard and comparison with influenza vaccine named Vaxigrip
- Conditions
- Seasonal flu vaccination.Influenza due to certain identified influenza viruses
- Registration Number
- IRCT20240409061458N1
- Lead Sponsor
- ivad Pharmed Salamat
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 734
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method