Evaluation of the immunogenicity and safety of quadrivalent seasonal flu vaccine and comparison with influenza vaccine named Vaxigrip

Phase 3

Recruiting

• Conditions: seasonal flu vaccination.; Influenza due to certain identified influenza viruses

• Registration Number: IRCT20200318046812N4
• Lead Sponsor: ivad Pharmed Salamat Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1369

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.