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: a randomized, double-blinded clinical trial

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210901052358N5

Enrollment

110

Registered

2022-10-04

Start date

2022-11-06

Completion date

Unknown

Last updated

2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza. Influenza due to certain identified influenza viruses

Interventions

Intervention 1: Intervention group: Receives pre-filled syringe of Fluguard seasonal flu vaccine (manufactured by Nivad Pharmed Salamat) 45µg HA / serotype / dose, intramuscular injection (non-dominan

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age equal to or above 18 years to 60 years have provided written informed consent Healthy volunteers or those with a history of underlying disease who have stable medical conditions in the last three months

Exclusion criteria

Exclusion criteria: Participation in other clinical trials Pregnancy and breastfeeding symptomatic COVID infection Fever on arrival or within 3 days prior to visit History of influenza vaccination up to 6 months before participating in the study History of severe hypersensitivity to any type of vaccine (anaphylactic shock) History of Guillain Barre or other demyelinating diseases COVID-19 vaccine injection at least 2 weeks before participating in the study Having an immunodeficiency disease or taking immunosuppressive drugs

Design outcomes

Primary

Measure	Time frame
Ratio of antibody titer against influenza virus with GMT scale after 28 days. Timepoint: Day zero and 28. Method of measurement: ELISA.;Seroconversion rate against hemagglutinin protein of influenza virus after 28 days. Timepoint: Day zero and 28. Method of measurement: ELISA.;Seroprotection rate against hemagglutinin protein of influenza virus after 28 days. Timepoint: Day zero and 28. Method of measurement: ELISA.	—

Measure

Time frame

Ratio of antibody titer against influenza virus with GMT scale after 28 days. Timepoint: Day zero and 28. Method of measurement: ELISA.;Seroconversion rate against hemagglutinin protein of influenza virus after 28 days. Timepoint: Day zero and 28. Method of measurement: ELISA.;Seroprotection rate against hemagglutinin protein of influenza virus after 28 days. Timepoint: Day zero and 28. Method of measurement: ELISA.

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Secondary

Measure	Time frame
Number of participants with Solicited Local and Systemic Adverse Drug Reactions. Timepoint: Days 0, 1, 4, 7 after injection. Method of measurement: Interview.;Number of participants with Unsolicited Adverse Events. Timepoint: Days 0, 1, 4, 7, 14 after injection. Method of measurement: Interview.;Number of participants with vasovagal syncope. Timepoint: Days 0-6. Method of measurement: Interview.;Number of participants with fever. Timepoint: Days 0-6. Method of measurement: Interview.;Number of volunteers with Adverse Events of Special Interest (AESIs). Timepoint: up to 3 months after injection. Method of measurement: Interview.;Number of volunteers with Medically Attended Adverse Events (MAEs). Timepoint: up to 14 days after injection. Method of measurement: Interview.;Number of volunteers with serious adverse events. Timepoint: throughout the study. Method of measurement: Interview.	—

Measure

Time frame

Number of participants with Solicited Local and Systemic Adverse Drug Reactions. Timepoint: Days 0, 1, 4, 7 after injection. Method of measurement: Interview.;Number of participants with Unsolicited Adverse Events. Timepoint: Days 0, 1, 4, 7, 14 after injection. Method of measurement: Interview.;Number of participants with vasovagal syncope. Timepoint: Days 0-6. Method of measurement: Interview.;Number of participants with fever. Timepoint: Days 0-6. Method of measurement: Interview.;Number of volunteers with Adverse Events of Special Interest (AESIs). Timepoint: up to 3 months after injection. Method of measurement: Interview.;Number of volunteers with Medically Attended Adverse Events (MAEs). Timepoint: up to 14 days after injection. Method of measurement: Interview.;Number of volunteers with serious adverse events. Timepoint: throughout the study. Method of measurement: Interview.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehnaz Hedayatjoo

Arta zist pharmed

b.hedayatjoo@artapharmed.com+98 21 8609 2503

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 9, 2026