Protocol summary
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Study aim
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Immunogenicity determination of fluguard vaccine in comparison with vaxigrip in an inferiority study design
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Design
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This study is a phase 3 study with active control group, randomized (with a ratio of 1: 1), two-arm, parallel, double-blind and with non-inferiority design
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Settings and conduct
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This study was performed on healthy volunteers aged 18 to 49 years in Tehran in 1399. The place of study is located in Tehran and Enghelab Street. On the day of screening, blood samples (for routine test and baseline Antibody titer) and Covid test will be taken from the volunteers. Two days later, the volunteer will return to receive the vaccine, then 28 days later, a blood sample will be taken from the volunteer again to measure the antibodies titer after injection. Vaccines in both groups are in single-form envelopes and random codes are used to identify them, so the candidate will not be informed of the type of vaccine received.
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Participants/Inclusion and exclusion criteria
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1. Age between 18-49
2. Have general health
3. Sign informed consent
4. Be able to accompany with the visit programs and study process
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Intervention groups
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1. Pre-filled syringe of fluguard, quadrivalent vaccine, (manufactured by Nivad pharmed), 45μg HA/serotype/dose, intramuscular injection (Non-dominant hand deltoid muscle), 0.5 ml per visit
2. Pre-filled syringe of Vaxigrip, quadrivalent vaccine, (manufactured by Sanofi), 15μg HA/serotype/dose, intramuscular injection (Non-dominant hand deltoid muscle), 0.5 ml per visit
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Main outcome variables
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Ratio of antibody titer against hemagglutinin protein of species A H1N1, A H3N2, B Yamagata, B Victoria with GMT scale after 28 days compared to the control group
General information
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Reason for update
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Increase and modify the sample size
Add new Exclusion criteria
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200318046812N4
Registration date:
2021-01-21, 1399/11/02
Registration timing:
registered_while_recruiting
Last update:
2021-01-23, 1399/11/04
Update count:
1
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Registration date
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2021-01-21, 1399/11/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-01-20, 1399/11/01
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Expected recruitment end date
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2021-03-19, 1399/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Evaluation of the immunogenicity and safety of quadrivalent seasonal flu vaccine and comparison with influenza vaccine named Vaxigrip
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 49 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Data analyser
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Sample size
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Target sample size:
1369
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random sequencing of volunteers is done by sealedenvelope.com. Using random blocks each block size is 4 will be constructed for a total of 1150 volunteers (2: 1 ratio).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Due to the similarity of the control and test drug packages and also random codes are used to identify them, the candidates will not be informed about the type of vaccine they received. Also, according to the identity codes of each patient that is created at the beginning of the study, the study data will be provided anonymously to the study results analysis team. Thus, the study is blinded for the patient and the evaluator.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-01-12, 1399/10/23
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Ethics committee reference number
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IR.NREC.1399.004
Health conditions studied
1
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Description of health condition studied
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seasonal flu vaccination
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ICD-10 code
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J09
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ICD-10 code description
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Influenza due to certain identified influenza viruses
Primary outcomes
1
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Description
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Ratio of antibody titer against hemagglutinin protein of species A H1N1 with GMT scale after 28 days compared to control group
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Timepoint
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Day zero and 28
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Method of measurement
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ELISA
2
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Description
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Ratio of antibody titer against hemagglutinin protein of species A H3N2 with GMT scale after 28 days compared to the control group
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Timepoint
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Day zero and 28
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Method of measurement
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ELISA
3
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Description
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Ratio of antibody titer against Yamagata species B hemagglutinin protein with GMT scale after 28 days compared to control group
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Timepoint
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Day zero and 28
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Method of measurement
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ELISA
4
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Description
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Ratio of antibody titer against Victoria B species hemagglutinin protein with GMT scale after 28 days compared to control group
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Timepoint
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Day zero and 28
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Method of measurement
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ELISA
Secondary outcomes
1
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Description
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Seroconversion rate against hemagglutinin protein species A H1N1 after 28 days
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Timepoint
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Day zero and 28
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Method of measurement
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ELISA
2
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Description
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Seroconversion rate against hemagglutinin protein species A H3N2 after 28 days
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Timepoint
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Day zero and 28
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Method of measurement
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ELISA
3
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Description
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Seroconversion rate against Yamagata species B hemagglutinin protein after 28 days
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Timepoint
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Day zero and 28
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Method of measurement
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ELISA
4
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Description
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Seroconversion rate against Victoria B species hemagglutinin protein after 28 days
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Timepoint
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Day zero and 28
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Method of measurement
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ELISA
Intervention groups
1
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Description
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Intervention group: Pre-filled syringe of Fluguard seasonal flu vaccine (manufactured by Nivad Pharmed Salamat) 45μg HA / serotype / dose, intramuscular injection (non-dominant hand deltoid muscle) of 0.5 ml at the first visit
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Category
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Prevention
2
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Description
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Control group: Pre-filled Vaxigrip Seasonal Influenza Vaccine Syringe (manufactured by Sanofi), 15μg HA / serotype / dose, intramuscular injection (non-dominant hand deltoid muscle) 0.5 ml at first visit
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Nivad Pharmed Salamat Company
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Because of confidentiality
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available