IRCT20200318046812N4 IRCT 2021-01-21 Nivad Pharmed Salamat Company Evaluation of the immunogenicity and safety of quadrivalent seasonal flu vaccine and comparison with influenza vaccine named Vaxigrip Evaluation of the immunogenicity and safety of quadrivalent flu vaccine (Fluguard) manufactured by Nivad pharmed Salamat, in comparison with seasonal flu vaccine Vaxigrip, as a reference product made by Sanofi, France in healthy volunteers aged 18 to 49 years, study Clinical phase 3 random, double-blind, double-arm, parallel, active control, non-inferiority 2021-01-20 anticipated 1369 Complete https://irct.ir/trial/52619 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random sequencing of volunteers is done by sealedenvelope.com. Using random blocks each block size is 4 will be constructed for a total of 1150 volunteers (2: 1 ratio), Blinding description: Due to the similarity of the control and test drug packages and also random codes are used to identify them, the candidates will not be informed about the type of vaccine they received. Also, according to the identity codes of each patient that is created at the beginning of the study, the study data will be provided anonymously to the study results analysis team. Thus, the study is blinded for the patient and the evaluator. 3 seasonal flu vaccination. Intervention 1: Intervention group: Pre-filled syringe of Fluguard seasonal flu vaccine (manufactured by Nivad Pharmed Salamat) 45μg HA / serotype / dose, intramuscular injection (non-dominant hand deltoid muscle) of 0.5 ml at the first visit. Intervention 2: Control group: Pre-filled Vaxigrip Seasonal Influenza Vaccine Syringe (manufactured by Sanofi), 15μg HA / serotype / dose, intramuscular injection (non-dominant hand deltoid muscle) 0.5 ml at first visit. No - There is not a plan to make this available Justification or reason for not sharing IPD is Because of confidentiality