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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200318046812N4

Enrollment

1369

Registered

2021-01-21

Start date

2021-01-20

Completion date

Unknown

Last updated

2021-02-22

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

Conditions

seasonal flu vaccination. Influenza due to certain identified influenza viruses

Interventions

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 de

Eligibility

Sex/Gender

All

Age

18 Years to 49 Years

Inclusion criteria

Inclusion criteria: Age between 18-49 Have general health Sign informed consent Be able to accompany with the visit programs and study process

Exclusion criteria

Exclusion criteria: History of previous vaccinations against influenza strains used in injectable vaccines during the previous 6 months History of allergy to Vaxigrip Received another vaccine during this study Covid-19 infection (PCR confirmation) Diagnosis of any disease, receiving medication or vaccine within 30 days before enrollment Underlying disease or therapeutic intervention that may adversely affect the immune response Participate in other clinical studies Pregnancy, breastfeeding or pregnancy planning during the study period Any conditions that prevent the study volunteer from enrollment, due to PI opinion such as: • Receiving immunomodulatory drugs or immunosuppressants • Receiving immunoglobulins • History of allergic reactions or Guillain-Barre syndrome • Autoimmune diseases A history of previous hospitalization with flu-like symptoms or a proven flu illness

Design outcomes

Primary

Measure	Time frame
Ratio of antibody titer against hemagglutinin protein of species A H1N1 with GMT scale after 28 days compared to control group. Timepoint: Day zero and 28. Method of measurement: ELISA.;Ratio of antibody titer against hemagglutinin protein of species A H3N2 with GMT scale after 28 days compared to the control group. Timepoint: Day zero and 28. Method of measurement: ELISA.;Ratio of antibody titer against Yamagata species B hemagglutinin protein with GMT scale after 28 days compared to control group. Timepoint: Day zero and 28. Method of measurement: ELISA.;Ratio of antibody titer against Victoria B species hemagglutinin protein with GMT scale after 28 days compared to control group. Timepoint: Day zero and 28. Method of measurement: ELISA.	—

Measure

Time frame

Ratio of antibody titer against hemagglutinin protein of species A H1N1 with GMT scale after 28 days compared to control group. Timepoint: Day zero and 28. Method of measurement: ELISA.;Ratio of antibody titer against hemagglutinin protein of species A H3N2 with GMT scale after 28 days compared to the control group. Timepoint: Day zero and 28. Method of measurement: ELISA.;Ratio of antibody titer against Yamagata species B hemagglutinin protein with GMT scale after 28 days compared to control group. Timepoint: Day zero and 28. Method of measurement: ELISA.;Ratio of antibody titer against Victoria B species hemagglutinin protein with GMT scale after 28 days compared to control group. Timepoint: Day zero and 28. Method of measurement: ELISA.

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Secondary

Measure	Time frame
Seroconversion rate against hemagglutinin protein species A H1N1 after 28 days. Timepoint: Day zero and 28. Method of measurement: ELISA.;Seroconversion rate against hemagglutinin protein species A H3N2 after 28 days. Timepoint: Day zero and 28. Method of measurement: ELISA.;Seroconversion rate against Yamagata species B hemagglutinin protein after 28 days. Timepoint: Day zero and 28. Method of measurement: ELISA.;Seroconversion rate against Victoria B species hemagglutinin protein after 28 days. Timepoint: Day zero and 28. Method of measurement: ELISA.	—

Measure

Time frame

Seroconversion rate against hemagglutinin protein species A H1N1 after 28 days. Timepoint: Day zero and 28. Method of measurement: ELISA.;Seroconversion rate against hemagglutinin protein species A H3N2 after 28 days. Timepoint: Day zero and 28. Method of measurement: ELISA.;Seroconversion rate against Yamagata species B hemagglutinin protein after 28 days. Timepoint: Day zero and 28. Method of measurement: ELISA.;Seroconversion rate against Victoria B species hemagglutinin protein after 28 days. Timepoint: Day zero and 28. Method of measurement: ELISA.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Setayesh Sadeghi

Nivad pharmed Salamat Co.

sadeghi.setayesh@gmail.com+98 21 9107 7022

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026