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Study aim
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Immunogenicity and safety evaluation of quadrivalent influenza vaccine Fluguard in comparison with Vaxigrip in 9-18 years old
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Design
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This phase 3 study with active control group, randomized (ratio of 1: 1), two-armed, parallel, double-blind and non-inferiority design in 734 healthy volunteers
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Settings and conduct
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This study will be conducted on healthy volunteers aged 9 to 18 in Imam Khomeini Complex Hospital. On the day of screening, blood samples (routine test and baseline Antibody titer) will be collected. Two days later, the volunteer will return to receive the vaccine. Then 28 days later, a blood sample will be taken from the volunteer again to measure the antibodies titer after injection. Vaccines in both groups are in single-form envelopes and random codes are used to identify them.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Age between 9-18, general health, Sign informed consent, Accompany with visits
Exclusion Criteria: new season Flu vaccination, allergy to egg or Vaxigrip, chronic disease like acute viral respiratory infection, coagulopathy, congenital immunodeficiency, acute infectious disease, transplant, neurological and cardiovascular disorder, asthma, malignancy, receiving live attenuated vaccine within 30 days pre-study, immunosuppressant drugs, immunoglobulins and blood products, History of Guillain-Barre, married women under 18
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Intervention groups
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Intervention: Pre-filled syringe of quadrivalent influenza vaccine, 45 microgram hemagglutinin protein for each serotype, intramuscular injection at day 1
Control: Pre-filled syringe of quadrivalent influenza vaccine, 15 microgram hemagglutinin protein for each serotype, intramuscular injection at day 1
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Main outcome variables
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Geometric mean ratio of antibody titer against hemagglutinin protein of species A H1N1, A H3N2, B Yamagata, B Victoria with GMT scale after 28 days compared to the control group