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Immunogenicity and safety evaluation of FluGuard® (quadrivalent recombinant influenza vaccine manufactured by Nivad Pharmed Salamat), in comparison with Vaxigrip Tetra (quadrivalent inactivated influenza vaccine manufactured by Sanofi Pasteur) in a double-blind, active-controlled, parallel, non-inferiority clinical trial in healthy voluntaries aged 9 to 18 years

Protocol summary

Study aim
Immunogenicity determination of fluguard vaccine in comparison with vaxigrip in an inferiority study design
Design
Phase III, double-blind, active-controlled, parallel, clinical trial, sample size of 734, stratified randomization
Settings and conduct
A Phase III, Double-blind (Investigator and Participant), Two-arm, Active-controlled, with a 1:1 allocation and sample size of 734, non-inferiority for Immunogenicity and safety evaluation of FluGuard® (quadrivalent recombinant influenza vaccine manufactured by Nivad Pharmed Salamat), in comparison with Vaxigrip Tetra (quadrivalent inactivated influenza vaccine manufactured by Sanofi Pasteur), clinical trial in healthy voluntaries aged 9 to 18 years
Participants/Inclusion and exclusion criteria
Subjects with general health between the ages of 9 and 18 who are willing and able to participate in the study. Subjects with a history of allergy to vaccine components and a history of influenza vaccination in the past 6 months, as well as people with conditions such as thrombocytopenia, acute infection, receiving immunomodulatory drugs, neurological disorders, etc. are excluded from the study.
Intervention groups
Fluguard Vaxigrip
Main outcome variables
Geometric mean ratio of antibody titer against hemagglutinin protein of types AH1N1, A H3N2, B Yamagata, and B Victoria with GMT scale after 28 days; And Seroconversion rate against hemagglutinin protein of types AH1N1, A H3N2, B Yamagata, and B Victoria after 28 days

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240626062259N2
Registration date: 2024-09-17, 1403/06/27
Registration timing: prospective

Last update: 2024-09-17, 1403/06/27
Update count: 0
Registration date
2024-09-17, 1403/06/27
Registrant information
Name
Seyyedeh Maryam Afshani
Name of organization / entity
Nivad Pharmed Salamat
Country
Iran (Islamic Republic of)
Phone
+98 21 9120 0238
Email address
info@nivadpharmed.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-30, 1403/07/09
Expected recruitment end date
2024-10-30, 1403/08/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Immunogenicity and safety evaluation of FluGuard® (quadrivalent recombinant influenza vaccine manufactured by Nivad Pharmed Salamat), in comparison with Vaxigrip Tetra (quadrivalent inactivated influenza vaccine manufactured by Sanofi Pasteur) in a double-blind, active-controlled, parallel, non-inferiority clinical trial in healthy voluntaries aged 9 to 18 years
Public title
A phase III clinical trial to assess iimunogenicity and safety of FluGuard® (quadrivalent recombinant influenza vaccine, Nivad Pharmed Salamat)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 9-18 years People with general health (through clinical examinations and medical records) Providing informed and voluntary written consent for participation in the study by subjects ≥ 14 y/o Providing informed and voluntary written consent for participation in the study by the parents of subjects Ability to accompany the visits and the study follow-up
Exclusion criteria:
History of vaccination against influenza strains used in the study vaccine, within 6 months before the start of the study History of allergy to eggs or vaxigrip vaccine or its components Any illness with evidence of acute viral respiratory infection Thrombocytopenia (platelets < 150,000) Coagulation disorders Receiving anticoagulant during the last 3 months The impossibility of administering drugs intramuscularly Congenital or acquired diseases indicating immune system defects or autoimmune diseases Acute phase of infectious disease, such as having an oral temperature of more than 37.7oC during the 7 days before the start of the study Receiving live attenuated vaccine within 30 days prior to study entry Receiving immunomodulatory or immunosuppressant drugs, or long-term use of systemic corticosteroids (defined as receiving prednisolone at a dose of 2 mg/kg/day or an equivalent dose for more than 10 days in the past 3 months) Receiving immunoglobulins and blood products within 3 months before the start of the study History of Guillain-Barré syndrome Conditions such as neurological disorders and under treatment seizures (Except the history of seizures) Organ transplantation, cardiovascular diseases, and asthma History of malignancies and radiotherapy during the past 6 months Married women under the age of 18, pregnant or planning to become pregnant in female volunteers
Age
From 9 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 734
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, subjects are allocated to two treatment groups, Fluguard® (product of Nivad Pharmed Salamat Company) and Vaxigrip (reference vaccine, produced by Sanofi Company(. Randomization will be stratified according to age groups: children (9-11) and teenagers (12-18).
Blinding (investigator's opinion)
Double blinded
Blinding description
double-blind Given that the control and test drug packages are completely identical and are identified using random codes, This ensures that the study remains blinded for both the doctor and the evaluator.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University of medical sciences
Street address
Sixth floor, Research Deputy of Tehran University of Medical Sciences, Ghods Street, Keshavarz Boulvard
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2024-03-12, 1402/12/22
Ethics committee reference number
IR.NREC.1402.005

Health conditions studied

1

Description of health condition studied
Seasonal flu
ICD-10 code
J10.1
ICD-10 code description
Influenza due to other identified influenza virus with other respiratory manifestations

Primary outcomes

1

Description
Geometric mean ratio of antibody titer against hemagglutinin protein of type A H1N1 with GMT scale after 28 days compared to control group
Timepoint
Day 28
Method of measurement
Hemagglutination Inhibition

2

Description
Geometric mean ratio of antibody titer against hemagglutinin protein of type A H3N2 with GMT scale after 28 days compared to control group
Timepoint
Day 28
Method of measurement
Hemagglutination Inhibition

3

Description
Geometric mean ratio of antibody titer againsthemagglutinin protein of type B Yamagata with GMTscale after 28 days compared to control group
Timepoint
Day 28
Method of measurement
Hemagglutination Inhibition

4

Description
Geometric mean ratio of antibody titer against hemagglutinin protein of type B Victoria with GMT scale after 28 days compared to control group
Timepoint
Day 28
Method of measurement
Hemagglutination Inhibition

5

Description
Seroconversion rate against hemagglutinin protein of type A H1N1 after 28 days compared to control group
Timepoint
Day 0, Day 28
Method of measurement
Hemagglutination Inhibition

6

Description
Seroconversion rate against hemagglutinin protein of type A H3N2 after 28 days compared to control group
Timepoint
Day 0, Day 28
Method of measurement
Hemagglutination Inhibitio

7

Description
Seroconversion rate against hemagglutinin protein of type B Yamagata after 28 days compared to control group
Timepoint
Day 0, Day 28
Method of measurement
Hemagglutination Inhibition

8

Description
Seroconversion rate against hemagglutinin protein of type B Victoria after 28 days compared to control group
Timepoint
Day 0, Day 28
Method of measurement
Hemagglutination Inhibition

Secondary outcomes

1

Description
Proportion of subjects with seroconversion against the hemagglutinin protein of types A H1N1, A H3N2, B Yamagata and B Victoria after 28 days in both groups
Timepoint
Day 0, Day 28
Method of measurement
Hemagglutination Inhibition

2

Description
Proportion of subjects with HI antibody serum titer ≥ 1:40 (% ≥ 1:40) against A H1N1, A H3N2, B Yamagata and B Victoria types after 28 days in both groups
Timepoint
Day 28
Method of measurement
Hemagglutination Inhibition

3

Description
Number of subjects with Immediate Adverse Drug Reactions in an hour following vaccination
Timepoint
Day 0
Method of measurement
Reported Immediate Adverse Drug Reactions

4

Description
Number of subjects with Solicited Adverse Drug Reactions during 7 days post vaccination
Timepoint
Day 0 to 7
Method of measurement
Number of reprted Solicited Adverse Drug Reactions in diary cards or call center

5

Description
Number of subjects with Unsolicited Adverse Drug Reactions during 7 days post vaccination
Timepoint
Day 0 to 7
Method of measurement
Reprted Unsolicited Adverse Drug Reactions in diary cards or call center

6

Description
Number of subjects with vasovagal syncope during 7 days post vaccination according to VAERS
Timepoint
Day 0 to 7
Method of measurement
Reported vasovagal syncope in diary cards or call center with principal investigator approval

7

Description
Number of subject with garde 3 fever related to vaccination during 7 days post vaccination
Timepoint
Day 0 to 7
Method of measurement
Reported fever with grade 3 (above 39 degree of centigrade) and related to vaccination in diary cards or call center

8

Description
Number of subjects with Unsolicited Adverse Drug Reqactions during day 7 until 28 following vaccination
Timepoint
Day 7 to 28
Method of measurement
Reprted Unsolicited Adverse Drug Reactions in diary cards or call center

9

Description
Number of subjects with Adverse Events of Special Interest (AESIs) 3 months following vaccination
Timepoint
Day 0 to 90
Method of measurement
Reported AESIs in diary cards or call center with principal investigator approval

10

Description
Number of subjects with Medically Attended Adverse Events (MAEs) following 28 days of vaccination
Timepoint
Day 0 to 28
Method of measurement
Reported MAEs in diary cards or call center

11

Description
Number of subjects with Serious Adverse Events (SAEs) during 6 months post vaccination
Timepoint
Day 0 to 180
Method of measurement
Reported SAEs in diary cards or call center with principal investigator approval

12

Description
Number of subjects with Delayed Adverse Events during 6 months post vaccination
Timepoint
Day 31 to 180
Method of measurement
Reported Delayed Adverse Events with principal investigator approval

Intervention groups

1

Description
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) at a dose of 0.5 ml at the first visit
Category
Prevention

2

Description
Control group: Pre-filled Vaxigrip seasonal influenza vaccine(manufactured by Sanofi), 15μg HA / serotype / dose,intramuscular injection (non-dominant hand deltoid muscle) at a dose of 0.5 ml at the first visit
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Mehr Hospital
Full name of responsible person
Dr. Mohammad Reza Salehi
Street address
Mehr Hospital, West Zartosht Street, Valiasr Square
City
Tehran
Province
Tehran
Postal code
۱۴۱۵۷۵۵۴۱۵
Phone
+98 912 315 9842
Email
salalehi.momamd3@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Nivad Pharmed Salamat Co.
Full name of responsible person
Dr. Mohammad Amin Ghobadi
Street address
NO.125. 22nd km of Tehran-karaj Makhsous Road, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3164949682
Phone
+98 21 9120 0238
Email
a.ghobadi@nivadpharmed.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nivad Pharmed Salamat Co.
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Orchid Pharmed Co.
Full name of responsible person
Dr. Hamidreza Kafi
Position
Medical Department Manager
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 42. Attar sq, Attar st, Valiasr st, Vanak sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1994766411
Phone
+98 21 4347 3000
Email
kafi.h@orchidpharmed.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Orchid Pharmed Co.
Full name of responsible person
Dr. Hamidreza Kafi
Position
Medical Department Manager
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 42. Attar sq, Attar st, Valiasr st, Vanak sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1994766411
Phone
+98 21 4347 3000
Email
kafi.h@orchidpharmed.com

Person responsible for updating data

Contact
Name of organization / entity
Orchid Pharmed Co.
Full name of responsible person
Dr. Hamidreza Kafi
Position
Medical Department Manager
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 42, Attar St., Vanak Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1994766411
Phone
+98 21 4347 3000
Email
Kafi.H@orchidpharmed.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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