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

Phase 4

Recruiting

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

• Registration Number: IRCT20210901052358N5
• 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: 21 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 110

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
umber 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.