Investigating the comparative preventive efficacy and safety of FluGaurd® (a 4-valent recombinant influenza vaccine, produced by Niwad-Pharmed-Salamat company, I.R.Iran), to Vaxigrip® (produced by Sanofi company, France) as the reference product in Healthy volunteers
Investigating the comparative preventive efficacy and safety of Flugaurd, to Vaxigrip as the reference product in Healthy volunteers
Design
This study is designed as a phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial in healthy volunteers.
Settings and conduct
Volunteers who are eligible to enter, will be enrolled. Administration will be done at the vaccination clinic of Baqiyatallah hospital.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: The age of the volunteer is between 18 and 49 years; The volunteer has general health; The volunteer or his/her legal guardian must have signed the informed consent form; The volunteer must be able to keep up with the monitoring programs.
Exclusion Criteria:Have a history of previous vaccinations against influenza strains used in this vaccines; Have a history of allergy to Vaxigrip;
History of chronic use immunosuppressive/modulator drugs in the last 6 months; History of any immune system disorders; History of chronic diseases; History of receiving immunoglobulins or other blood products 90 days before the vaccination; Pregnancy; Lactation.
Intervention groups
Intervention group: Pre-filled syringe of Flugaurd, 45μg HA/serotype/dose, intramuscular injection (at non-dominant hand deltoid muscle) in the amount of 0.5 ml in the first visit.
Control group: Pre-filled syringe of Vaxigrip, 45μg HA/serotype/dose, intramuscular injection (at non-dominant hand deltoid muscle) in the amount of 0.5 ml in the first visit.
Main outcome variables
The ratio of antibody titer against hemagglutinin proteins type A H1N1، A H3N2، B Victoria، B Yamagata with GMT scale after 28 days compared to the control group; The difference in seroconversion rate against the A H1N1، A H3N2، B Victoria، B Yamagata hemagglutinin proteins after 28 days compared to the control group;
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001165N61
Registration date:2020-06-12, 1399/03/23
Registration timing:prospective
Last update:2020-06-12, 1399/03/23
Update count:0
Registration date
2020-06-12, 1399/03/23
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the comparative preventive efficacy and safety of FluGaurd® (a 4-valent recombinant influenza vaccine, produced by Niwad-Pharmed-Salamat company, I.R.Iran), to Vaxigrip® (produced by Sanofi company, France) as the reference product in Healthy volunteers
Public title
Investigating the comparative preventive efficacy and safety of FluGaurd® (a 4-valent recombinant influenza vaccine, produced by Niwad-Pharmed-Salamat company, I.R.Iran), to Vaxigrip® (produced by Sanofi company, France) as the reference product in Healthy volunteers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The age of the volunteer is between 18 and 49 years.
The volunteer has general health (through clinical examinations and medical records).
The volunteer or his/her legal guardian must have signed the informed consent form.
The volunteer must be able to keep up with the monitoring programs.
Exclusion criteria:
Have a history of previous vaccinations against influenza strains used in injectable vaccines;
Have a history of allergy to Vaxigrip;
History of chronic use (more than 14 days) immunosuppressive drugs in the last 6 months (in the case of corticosteroids, prednisolone (or its equivalents) in the amount of 0.5 mg per kg of volunteer weight per day. Topical or inhaled steroids usage are free.)
History of any immune system disorders such as Guillain-Barré syndrome and other Masculoscletal disorders;
History of chronic diseases such as cancer, liver and kidney disease, neurological disorders, diabetes;
History of receiving immunoglobulins or other blood products 90 days before the vaccine injection;
Pregnancy;
Lactation.
Age
From 18 years old to 49 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization method is used to randomized the patients.
For randomization, we visited the www.sealedenvelope.com, then randomization tab and make a list option were selected, the number of intervention groups, sample size, block size (which was selected due to the small sample size, 4 )were entered the intended locations, then a random list containing the pattern of patient allocation was obtained in two intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be done as a double blind RCT.
The Vaxigrip vaccine, in a very similar appearance to the Flugaurd vaccine, will be given to the main researcher by the Flugaurd's manufacturer , and the drug and control are distinguished only by the code that only the main researcher is aware of.
Prescribers and volunteers will be unaware of the drug / product control.
The results will be recorded in the checklist based on the code registered on the drug and the analysis will be done based on the codes.
At the end of the study, the meaning of each code will be determined.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah Medical Sciences University
Street address
Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۳۵۹۱۵۳۷۱
Approval date
2020-05-16, 1399/02/27
Ethics committee reference number
IR.BMSU.REC.1399.175
Health conditions studied
1
Description of health condition studied
Seasonal Influenza
ICD-10 code
J09
ICD-10 code description
Influenza due to certain identified influenza viruses
Primary outcomes
1
Description
The ratio of antibody titer against hemagglutinin protein type A H1N1 with GMT scale compared to the control group at day 28 days;
Timepoint
At the baseline, then on day 28.
Method of measurement
Blood sampling.
2
Description
The ratio of antibody titer against hemagglutinin protein type A H3N2 with GMT scale compared to the control group at day 28 days;
Timepoint
At the baseline, then on day 28.
Method of measurement
Blood sampling.
3
Description
The ratio of antibody titer against hemagglutinin protein type B Yamagata with GMT scale compared to the control group at day 28 days;
Timepoint
At the baseline, then on day 28.
Method of measurement
Blood sampling.
4
Description
The ratio of antibody titer against hemagglutinin protein type B Victoria with GMT scale compared to the control group at day 28 days;
Timepoint
At the baseline, then on day 28.
Method of measurement
Blood sampling.
5
Description
Seroconversion rate difference against hemagglutinin protein type A H1N1 after 28 days compared to the control group;
Timepoint
At the baseline, then on day 28.
Method of measurement
Blood sampling.
6
Description
Seroconversion rate difference against hemagglutinin protein type A H3N2 after 28 days compared to the control group;
Timepoint
At the baseline, then on day 28.
Method of measurement
Blood sampling.
7
Description
Seroconversion rate difference against hemagglutinin protein type B Yamagata after 28 days compared to the control group;
Timepoint
At the baseline, then on day 28.
Method of measurement
Blood sampling.
8
Description
Seroconversion rate difference against hemagglutinin protein type B Victoria after 28 days compared to the control group;
Timepoint
At the baseline, then on day 28.
Method of measurement
Blood sampling.
Secondary outcomes
1
Description
The rate of occurrence of any local or systemic solicited complication;
Timepoint
Daily (from day 0 till the end of day 6)
Method of measurement
Monitoring by phone.
2
Description
The rate of occurrence of any unsolicited complication;
Timepoint
Daily
Method of measurement
Monitoring by phone
3
Description
The occurrence rate of any serious side adverse effect;
Timepoint
Daily
Method of measurement
Monitoring by phone
4
Description
Seroconversion rate against A H1N1 hemagglutinin protein after 28 days;
Timepoint
Baseline, then at day 28.
Method of measurement
Blood sample.
5
Description
Seroconversion rate against A H3N2 hemagglutinin protein after 28 days;
Timepoint
Baseline, then at day 28.
Method of measurement
Blood sample.
6
Description
Seroconversion rate against B Yamagata hemagglutinin protein after 28 days;
Timepoint
Baseline, then at day 28.
Method of measurement
Blood sample.
7
Description
Seroconversion rate against B Victoria hemagglutinin protein after 28 days;
Timepoint
Baseline, then at day 28.
Method of measurement
Blood sample.
8
Description
Seroprotection rate against َA H1N1 hemagglutinin protein after 28 days;
Timepoint
Baseline, then at day 28.
Method of measurement
Blood sample.
9
Description
Seroprotection rate against َA H3N2 hemagglutinin protein after 28 days;
Timepoint
Baseline, then at day 28.
Method of measurement
Blood sample.
10
Description
Seroprotection rate against َB Yamagata hemagglutinin protein after 28 days;
Timepoint
Baseline, then at day 28.
Method of measurement
Blood sample.
11
Description
Seroprotection rate against َB Victoria hemagglutinin protein after 28 days;
Timepoint
Baseline, then at day 28.
Method of measurement
Blood sample.
12
Description
changes in biochemistry and hematologic parameters (Sr Cr، BUN، ALT، AST، Bilirubin total & direct، CBC diff، Platelet،CD4, CD8, IgM, IgG INR، PTT، PT)
Timepoint
Baseline, then at day 28.
Method of measurement
Laboratory analysis of blood sample.
13
Description
Changes in Tumor Necrotizing Factor(TNF)-alfa serum level;
Timepoint
Baseline, then at day 28.
Method of measurement
Elisa Kit.
14
Description
Changes in Interleukin-1 serum level;
Timepoint
Baseline, then at day 28.
Method of measurement
Elisa Kit.
15
Description
Changes in Interleukin-6 serum level;
Timepoint
Baseline, then at day 28.
Method of measurement
Elisa Kit.
Intervention groups
1
Description
Intervention group: Pre-filled syringe of Flugaurd (the seasonal influenza vaccine, manufactured by Newad Farmad Salamat), 45 mg HA/serotype/dose, intramuscular injection (non-dominant hand deltoid muscle) in the amount of 0.5 ml in the first visit
Category
Prevention
2
Description
Control group: Pre-filled syringe of Vaxigrip ( the seasonal influenza vaccine, manufactured by Sanofi), 45 mg HA / serotype / dose, intramuscular injection (non-dominant hand deltoid muscle) in the amount of 0.5 ml in the first visit