Protocol summary

Study aim
Immunogenicity and safety evaluation of quadrivalent influenza vaccine Fluguard in comparison with Vaxigrip in 9-18 years old
Design
This phase 3 study with active control group, randomized (ratio of 1: 1), two-armed, parallel, double-blind and non-inferiority design in 734 healthy volunteers
Settings and conduct
This study will be conducted on healthy volunteers aged 9 to 18 in Imam Khomeini Complex Hospital. On the day of screening, blood samples (routine test and baseline Antibody titer) will be collected. 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.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 9-18, general health, Sign informed consent, Accompany with visits Exclusion Criteria: new season Flu vaccination, allergy to egg or Vaxigrip, chronic disease like acute viral respiratory infection, coagulopathy, congenital immunodeficiency, acute infectious disease, transplant, neurological and cardiovascular disorder, asthma, malignancy, receiving live attenuated vaccine within 30 days pre-study, immunosuppressant drugs, immunoglobulins and blood products, History of Guillain-Barre, married women under 18
Intervention groups
Intervention: Pre-filled syringe of quadrivalent influenza vaccine, 45 microgram hemagglutinin protein for each serotype, intramuscular injection at day 1 Control: Pre-filled syringe of quadrivalent influenza vaccine, 15 microgram hemagglutinin protein for each serotype, intramuscular injection at day 1
Main outcome variables
Geometric mean 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

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240409061458N1
Registration date: 2024-04-30, 1403/02/11
Registration timing: prospective

Last update: 2024-04-30, 1403/02/11
Update count: 0
Registration date
2024-04-30, 1403/02/11
Registrant information
Name
Emad Babazade
Name of organization / entity
CaRO Pharmed Alborz
Country
Iran (Islamic Republic of)
Phone
+98 26 9100 8180
Email address
e.babazade@caropharmed.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-05, 1403/06/15
Expected recruitment end date
2024-10-06, 1403/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Immunogenicity and safety evaluation of FluGuard® (seasonal quadrivalent recombinant influenza vaccine manufactured by Nivad Pharmed Salamat), in comparison with Vaxigrip Tetra (quadrivalent inactivated influenza vaccine manufactured by Sanofi Pasteur)
Public title
Evaluation of the immunogenicity and safety of quadrivalent seasonal flu vaccine named Fluguard and comparison with influenza vaccine named Vaxigrip
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 9-18 Have general health Sign informed consent for volunteers (over 14) Parents sign the informed consent form 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 new influenza season History of allergy to egg or Vaxigrip or Its components Any type of disease with evidence of acute viral respiratory infection Any conditions that prevent the study volunteer from enroll, such as: Thrombocytopenia (platelets less than 150,000), Coagulopathy, Receiving anticoagulants during last 3 months, Prohibition of IM drug administration, History of congenial or immunodeficiency or autoimmune disease, Acute phase of infectious disease, such as having a temperature of more than 37.7 °C during the 7 days before enrollment Receiving live attenuated vaccine within 30 days before enrollment Receiving immunomodulatory or immunosuppressant drugs, Receiving long-term systemic corticosteroid (corticosteroids for more than two weeks in the last 3 months or receiving prednisolone more than 2 mg/kg daily or its equivalent dose for more than 10 days) Receiving immunoglobulins and blood products within 3 months before enrollment History of Guillain-Barre syndrome Conditions such as neurological disorders and seizure under treatment (seizure history is not considered as exclusion criteria.) history of transplant, Cardiovascular disease, Asthma History of malignancies and radiotherapy during last 6 months Married women under the age of 18, pregnant or pregnancy planning in female volunteers
Age
From 9 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Investigator
  • Data analyser
Sample size
Target sample size: 734
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is designed as stratified block randomization. Two age groups of children (9-11) and youth (12-18) are considered. The random sequencing is done by the website sealedenvelope.com. Using randomly permuted blocks, blocks (blocks of size 2 and 4) will be made for a total of 734 volunteers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The packages of the control drug and the tested drug are completely similar, and random codes are also used to identify them. Also, according to the identity codes of each patient that are 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 to the physician and the study analyst.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research ethics committee of national research ethics committee
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1467664961
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 vaccination
ICD-10 code
J09
ICD-10 code description
Influenza due to certain identified influenza viruses

Primary outcomes

1

Description
Geometric Mean 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

2

Description
Geometric Mean Ratio of antibody titer against hemagglutinin protein of species A H13N2 with GMT scale after 28 days compared to control group
Timepoint
Day zero and 28
Method of measurement
ELISA

3

Description
Geometric Mean Ratio of antibody titer against hemagglutinin protein of species B Yamagata with GMT scale after 28 days compared to control group
Timepoint
Day zero and 28
Method of measurement
ELISA

4

Description
Geometric Mean Ratio of antibody titer against hemagglutinin protein of species B Victoria with GMT scale after 28 days compared to control group
Timepoint
Day zero and 28
Method of measurement
ELISA

5

Description
Seroconversion rate against hemagglutinin protein species A H1N1 after 28 days compared to control group
Timepoint
Day zero and 28
Method of measurement
ELISA

6

Description
Seroconversion rate against hemagglutinin protein species A H3N2 after 28 days compared to control group
Timepoint
Day zero and 28
Method of measurement
ELISA

7

Description
Seroconversion rate against hemagglutinin protein species B Yamagata after 28 days compared to control group
Timepoint
Day zero and 28
Method of measurement
ELISA

8

Description
Seroconversion rate against hemagglutinin protein species B Victoria after 28 days compared to control group
Timepoint
Day zero and 28
Method of measurement
ELISA

Secondary outcomes

1

Description
Seroconversion rate against hemagglutinin protein species A H1N1, A H3N2, B Yamagata and B Victoria after 28 days
Timepoint
Day zero and 28
Method of measurement
ELISA

2

Description
Number of volunteers with incidence of Immediate Adverse Drug Reactions
Timepoint
1 and 24 hour after vaccination
Method of measurement
Direct observation and reporting

3

Description
Number of volunteers with incidence of Solicited Adverse Drug Reactions
Timepoint
Days zero to 6 after vaccination
Method of measurement
Direct observation and reporting

4

Description
Number of volunteers with incidence of Unsolicited Adverse Drug Reactions
Timepoint
Days zero to 6 after vaccination
Method of measurement
Direct observation and reporting

5

Description
Number of volunteers with incidence of Vasovagal syncope According to VAERS (Vaccine Adverse Event Reporting System)
Timepoint
Days zero to 6 after vaccination
Method of measurement
Direct observation and reporting

6

Description
Number of volunteers with incidence of grade 3 fever related to vaccine
Timepoint
Days zero to 6 after vaccination
Method of measurement
Direct observation and reporting

7

Description
Number of volunteers with incidence of Unsolicited Adverse Drug Reactions
Timepoint
Days 7 to 28 after vaccination
Method of measurement
Direct observation and reporting

8

Description
Number of volunteers with incidence of Serious Adverse Events (SAEs)
Timepoint
Up to 6 months after vaccination
Method of measurement
Direct observation and reporting

9

Description
Number of volunteers with incidence of Delayed Adverse Events
Timepoint
From 1 to 6 months after vaccination
Method of measurement
Direct observation and reporting

Intervention groups

1

Description
Intervention group: Pre-filled syringe of Fluguard seasonal flu vaccine (manufactured by Nivad Pharmed Salamat) 45 microgram HA per serotype per dose, intramuscular injection (non-dominant hand deltoid muscle) of 0.5 milliliter at the first visit
Category
Prevention

2

Description
Control group: Pre-filled Vaxigrip Seasonal Influenza Vaccine Syringe (manufactured by Sanofi), 15 microgram HA per serotype per dose, intramuscular injection (non-dominant hand deltoid muscle) 0.5 ml at first visit
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Mohammad Reza Salehi
Street address
Dr Gharib Ave, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Web page address
https://ikhc.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Nivad Pharmed Salamat
Full name of responsible person
Dr.Mohammad Amin Ghobadi
Street address
No. 203, National Institute of Genetic Engineering and Biotechnology (NIGEB), Pajoohesh Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3164949682
Phone
+98 21 9120 0238
Email
info@nivadpharmed.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nivad Pharmed Salamat
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
CaRO Pharmed Alborz
Full name of responsible person
Dr. Setayesh Sadeghi
Position
CEO
Latest degree
Specialist
Other areas of specialty/work
Pharmacotherapy
Street address
National Institute of Genetic Engineering and Biotechnology (NIGEB), Pajoohesh Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1497719830
Phone
+98 26 9100 8180
Email
s.sadeghi@caropharmed.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Salehi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Dr. Gharib Ave,
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 0000
Email
mr-salehi@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
CaRO Pharmed Alborz
Full name of responsible person
Emad Babazade
Position
Project Manager
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 211, National Institute of Genetic Engineering and Biotechnology (NIGEB), Pajoohesh Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1497719830
Phone
+98 26 9100 8180
Fax
Email
e.babazade@caropharmed.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The individual data of the participants will not be published publicly except to the relevant authorities and legal organizations.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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