Immunogenicity and safety evaluation of FluGuard (quadrivalent recombinant influenza vaccine (serotypes of 2022/2023) manufactured by Nivad Pharmed Salamat), in comparison with Vaxigrip Tetra (quadrivalent inactivated influenza vaccine (serotypes of 2022/2023) manufactured by Sanofi Pasteur) in a Double-blind, active-controlled, parallel, non-inferiority Clinical trial in volunteers aged ≥ 18 to 60 years

Comparison of the immunogenicity and safety of the seasonal flu vaccine FluGuard® with the seasonal influenza vaccine Vaxigrip in people aged 18 to 60 years

Randomized, double-blinded clinical trial, with parallel groups (allocation ratio 1:1), and non-inferiority

This study is conducted on volunteers who referred to the vaccination department of Labafinejad Hospital in 1401. Eligible participants are randomly assigned into two groups. Fluguard seasonal flu vaccine is administered to one group and Vaxigrip seasonal flu vaccine is injected to the other group. Then, immunogenicity (day 28) and vaccine safety (day of injection and days 1, 4, 7, 14 and 28 after injection and 3 months later) are compared in two groups. In this double-blinded study, participants and health care providers are blinded to patient allocation.

The inclusions of this study are: age equal to or older than 18 years to 60 years, have provided written informed consent, healthy volunteers or with a history of an underlying disease that has stable medical conditions in the last three months. Exclusions: participation in other clinical trials, pregnancy and breastfeeding, symptomatic COVID infection, fever on arrival or within 3 days before the visit, influenza vaccine injection up to 6 months before participating in the study, severe hypersensitivity reaction to any type of vaccine. (anaphylactic shock), injection of COVID vaccine at least 2 weeks before participating in the study, underlying immunodeficiency disorders or the use of immunosuppressive drugs

Intervention receives FluGuard vaccine, manufactured by Nivad pharmed, intramuscular injection, 0.5 ml; control group receives Vaxigrip vaccine, (manufactured by Sanofi), intramuscular injection, 0.5 ml per visit

Immunogenicity, Safety

Correction of some typographical errors and the randomization section

Block randomization (block sizes of 4) would be performed using R 4.3.2 program and the randomization codes would be typed on sealed envelopes containing the vaccines. Random codes will be assigned to the participants according to the randomization sheet by the physician respective to enrollment date.

In this study, participants and clinical caregiver (who injects the vaccine, takes a blood sample, and evaluates the safety of the vaccine) will be unaware of allocation of the participants into the groups (double-blind).