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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General information
1150
1369
11501369
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Increase and modify the sample size
Add new Exclusion criteria
Increase and modify the sample size Add new Exclusion criteria
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افزایش و اصلاح حجم نمونه
افزودن معیار عدم ورود جدید
افزایش و اصلاح حجم نمونه افزودن معیار عدم ورود جدید
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
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
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
سابقه واکسیناسیون قبلی علیه سویه های آنفولانزا مورد استفاده در واکسن تزریقی در طی 6 ماه قبل
سابقه بروز حساسیت به واکسن Vaxigrip
اقدام به دریافت واکسن دیگر در مدت این مطالعه
ابتلا به Covid-19 (تایید با PCR)
تشخیص هر گونه بیماری، دریافت دارو یا واکسن طی 30 روز قبل از ورود به مطالعه
بیماری زمینه ای یا مداخله درمانی که ممکن است بر پاسخ ایمنی تأثیر منفی بگذارد
شرکت در سایر مطالعات بالینی
بارداری، شیردهی یا برنامه جهت بارداری در طی مدت مطالعه
هر گونه شرایطی که از نظر مجری مطالعه مانع ورود باشد، مانند:• دریافت داروهای ایمونومدولاتور یا ایمونوساپرسانت• دریافت ایمونوگلوبولین ها• سابقه واکنش های حساسیتی یا سندرم گیلن باره• بیماری های خودایمنی
سابقه واکسیناسیون قبلی علیه سویه های آنفولانزا مورد استفاده در واکسن تزریقی در طی 6 ماه قبل
سابقه بروز حساسیت به واکسن Vaxigrip
اقدام به دریافت واکسن دیگر در مدت این مطالعه
ابتلا به Covid-19 (تایید با PCR)
تشخیص هر گونه بیماری، دریافت دارو یا واکسن طی 30 روز قبل از ورود به مطالعه
بیماری زمینه ای یا مداخله درمانی که ممکن است بر پاسخ ایمنی تأثیر منفی بگذارد
شرکت در سایر مطالعات بالینی
بارداری، شیردهی یا برنامه جهت بارداری در طی مدت مطالعه
هر گونه شرایطی که از نظر مجری مطالعه مانع ورود باشد، مانند:• دریافت داروهای ایمونومدولاتور یا ایمونوساپرسانت• دریافت ایمونوگلوبولین ها• سابقه واکنش های حساسیتی یا سندرم گیلن باره• بیماری های خودایمنی
سابقه بستری قبلی با علائم مشابه آنفولانزا یا بیماری اثبات شده آنفولانزا
سابقه واکسیناسیون قبلی علیه سویه های آنفولانزا مورد استفاده در واکسن تزریقی در طی 6 ماه قبل سابقه بروز حساسیت به واکسن Vaxigrip اقدام به دریافت واکسن دیگر در مدت این مطالعه ابتلا به Covid-19 (تایید با PCR) تشخیص هر گونه بیماری، دریافت دارو یا واکسن طی 30 روز قبل از ورود به مطالعه بیماری زمینه ای یا مداخله درمانی که ممکن است بر پاسخ ایمنی تأثیر منفی بگذارد شرکت در سایر مطالعات بالینی بارداری، شیردهی یا برنامه جهت بارداری در طی مدت مطالعه هر گونه شرایطی که از نظر مجری مطالعه مانع ورود باشد، مانند:• دریافت داروهای ایمونومدولاتور یا ایمونوساپرسانت• دریافت ایمونوگلوبولین ها• سابقه واکنش های حساسیتی یا سندرم گیلن باره• بیماری های خودایمنی سابقه بستری قبلی با علائم مشابه آنفولانزا یا بیماری اثبات شده آنفولانزا
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).
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).
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).
ساخت توالی عددی تصادفی داوطلبان توسط وب سایت sealedenvelope.com به انجام می رسد. با استفاده از بلوک¬های جایگشت شده تصادفی، بلوک هایی (اندازه هر بلوک 4 است) برای مجموع 1150 داوطلب (با نسبت 2:1) ساخته خواهد شد.
ساخت توالی عددی تصادفی داوطلبان توسط وب سایت sealedenvelope.com به انجام می رسد. با استفاده از بلوک های جایگشت شده تصادفی، بلوک هایی (اندازه هر بلوک 4 است) برای مجموع 1369 داوطلب ساخته خواهد شد.
ساخت توالی عددی تصادفی داوطلبان توسط وب سایت sealedenvelope.com به انجام می رسد. با استفاده از بلوک¬های جایگشت شده تصادفی، بلوک هایی (اندازه هر بلوک 4 است) برای مجموع 11501369 داوطلب (با نسبت 2:1) ساخته خواهد شد.
Recruitment centers
#1
Name of recruitment center - English: Dr. Mohammad Hosseini Pharmacy
Name of recruitment center - Persian: داروخانه دکتر محمدحسینی
Full name of responsible person - English: Dr. Mostafa Ghanei
Full name of responsible person - Persian: دکتر مصطفی قانعی
Street address - English: No. 36, Shahid Nazari St., Enqelab St., Enghelab St., Dr. Mohammad Hosseini Pharmacy, Second Floor
Street address - Persian: خیابان انقلاب، خیابان ابوریحان، خیابان شهید نظری، پلاک 36، داروخانه دکترمحمدحسینی، طبقه دوم
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ١١٥٧٩٤٣٥٨٨
Phone: +98 21 6648 0876
Fax:
Email: sadeghi.setayesh@gmail.com
Web page address:
Name of recruitment center - English: Dr. Mohammad Hosseini Pharmacy
Name of recruitment center - Persian: داروخانه دکتر محمدحسینی
Full name of responsible person - English: Dr. Mostafa Ghanei
Full name of responsible person - Persian: دکتر مصطفی قانعی
Street address - English: No. 36, Shahid Nazari St., Enqelab St., Enghelab St., Dr. Mohammad Hosseini Pharmacy, Second Floor
Street address - Persian: خیابان انقلاب، خیابان ابوریحان، خیابان شهید نظری، پلاک 36، داروخانه دکترمحمدحسینی، طبقه دوم
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ١١٥٧٩٤٣٥٨٨
Phone: +98 21 6648 0876
Fax:
Email: nooshin185@yahoo.com
Web page address:
Name of recruitment center - English: Dr. Mohammad Hosseini Pharmacy Name of recruitment center - Persian: داروخانه دکتر محمدحسینی Full name of responsible person - English: Dr. Mostafa Ghanei Full name of responsible person - Persian: دکتر مصطفی قانعی Street address - English: No. 36, Shahid Nazari St., Enqelab St., Enghelab St., Dr. Mohammad Hosseini Pharmacy, Second Floor Street address - Persian: خیابان انقلاب، خیابان ابوریحان، خیابان شهید نظری، پلاک 36، داروخانه دکترمحمدحسینی، طبقه دوم City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ١١٥٧٩٤٣٥٨٨ Phone: +98 21 6648 0876 Fax: Email: sadeghi.setayeshnooshin185@gmail.comyahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Nivad Pharmed Salamat Company
Name of organization / entity - Persian: شرکت نیواد فارمد سلامت
Full name of responsible person - English: Dr. Setayesh Sadeghi
Full name of responsible person - Persian: دکتر ستایش صادقی
Street address - English: No. 54, Sharif Innovation Station, Above Hassan Hosseini Sq., Azadi St., Habibollah St., Nivad pharmed Salamat Co.
Street address - Persian: خیابان آزادی، خیابان حبیب اله، بالاتر از میدان حسن حسینی، ایستگاه نوآوری شریف، پلاک 54، شرکت نیواد فارمد سلامت
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1455714181
Phone: +98 21 9107 7022
Fax:
Email: info.nivad@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Nivad Pharmed Salamat Company
Name of organization / entity - Persian: شرکت نیواد فارمد سلامت
Full name of responsible person - English: Dr. Amirhossein Abdolghafari
Full name of responsible person - Persian: دکتر امیرحسین عبدالغفاری
Street address - English: No. 54, Sharif Innovation Station, Above Hassan Hosseini Sq., Azadi St., Habibollah St., Nivad pharmed Salamat Co.
Street address - Persian: خیابان آزادی، خیابان حبیب اله، بالاتر از میدان حسن حسینی، ایستگاه نوآوری شریف، پلاک 54، شرکت نیواد فارمد سلامت
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1455714181
Phone: +98 21 9107 7022
Fax:
Email: info.nivad@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Nivad Pharmed Salamat Company Name of organization / entity - Persian: شرکت نیواد فارمد سلامت Full name of responsible person - English: Dr. Setayesh SadeghiAmirhossein Abdolghafari Full name of responsible person - Persian: دکتر ستایش صادقیامیرحسین عبدالغفاری Street address - English: No. 54, Sharif Innovation Station, Above Hassan Hosseini Sq., Azadi St., Habibollah St., Nivad pharmed Salamat Co. Street address - Persian: خیابان آزادی، خیابان حبیب اله، بالاتر از میدان حسن حسینی، ایستگاه نوآوری شریف، پلاک 54، شرکت نیواد فارمد سلامت City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1455714181 Phone: +98 21 9107 7022 Fax: Email: info.nivad@gmail.com Web page address:
Protocol summary
Study aim
Immunogenicity determination of fluguard vaccine in comparison with vaxigrip in an inferiority study design
Design
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
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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
Main outcome variables
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
Increase and modify the sample size
Add new Exclusion criteria
Acronym
IRCT registration information
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
Registration date
2021-01-21, 1399/11/02
Registrant information
Name
Mostafa Ghanei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8860 0067
Email address
mghaneister@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Evaluation of the immunogenicity and safety of quadrivalent seasonal flu vaccine and comparison with influenza vaccine named Vaxigrip
Purpose
Prevention
Inclusion/Exclusion criteria
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
Age
From 18 years old to 49 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
1369
Randomization (investigator's opinion)
Randomized
Randomization description
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).
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Research Ethics Committee
Street address
Tehran - Ghods Town (West) - Between South Flamek and Zarafshan, Iran TV Street - Central Headquarters of the Ministry of Health, Treatment and Medical Education, Block A, 13th floor
City
Tehran
Province
Tehran
Postal code
3848176941
Approval date
2021-01-12, 1399/10/23
Ethics committee reference number
IR.NREC.1399.004
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
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
Ratio of antibody titer against hemagglutinin protein of species A H3N2 with GMT scale after 28 days compared to the control group
Timepoint
Day zero and 28
Method of measurement
ELISA
3
Description
Ratio of antibody titer against Yamagata species B hemagglutinin protein with GMT scale after 28 days compared to control group
Timepoint
Day zero and 28
Method of measurement
ELISA
4
Description
Ratio of antibody titer against Victoria B species hemagglutinin protein with GMT scale 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 after 28 days
Timepoint
Day zero and 28
Method of measurement
ELISA
2
Description
Seroconversion rate against hemagglutinin protein species A H3N2 after 28 days
Timepoint
Day zero and 28
Method of measurement
ELISA
3
Description
Seroconversion rate against Yamagata species B hemagglutinin protein after 28 days
Timepoint
Day zero and 28
Method of measurement
ELISA
4
Description
Seroconversion rate against Victoria B species hemagglutinin protein after 28 days
Timepoint
Day zero and 28
Method of measurement
ELISA
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) of 0.5 ml at the first visit
Category
Prevention
2
Description
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
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Mohammad Hosseini Pharmacy
Full name of responsible person
Dr. Mostafa Ghanei
Street address
No. 36, Shahid Nazari St., Enqelab St., Enghelab St., Dr. Mohammad Hosseini Pharmacy, Second Floor