Safety evaluation of a quadrivalent recombinant influenza vaccine (serotypes of 2021/2022) manufactured by Nivad Pharmed Salamat, open label, single arm, in volunteers aged ≥ 18 years.
Accurate safety assessment of the quadrivalent seasonal flu vaccine (2021-2022), Fluguard in the population receiving the vaccine
Design
Open Label, single arm on 1000 participants
Settings and conduct
Participants will install the web application, after registering the information and checking the eligibility, they are given a special code and then the call center team contacts the person and injects them the vaccine. The volunteer is present at the study site for 30 minutes after the injection, so that in case of any adverse events after the injection, the necessary measures will be taken by the research team. To follow up on other events, the team will call the participant after 1 day, 4 days, 7 days, 14 days after the injection. On the other hand, blood samples are collected in a subgroup of 250 participants to evaluate the immunogenicity of pre-vaccination and 28 days post-vaccination.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Aged ≥ 18 years; Able to provide informed consent; Willing to comply with the study visits; Healthy subjects or patients with stable concomitant disease
Exclusion Criteria: Subject is currently participating or is planning to participate in another trial; Females with confirmed pregnancy; planning on conceiving during the trial duration, and breastfeeding; Fever at the time of entry; Having an active infection with clinical signs of Covid-19; History of severe allergy to any type of vaccine; History of Guillain-Barré; Covid-19 vaccination at least 2 weeks before participation; receive Covid-19 vaccine for at least the next 2 weeks
Intervention groups
pre-filled syringe of Fluguard quadrivalent flu vaccine containing strains of 2021-2022, 45μg HA/ serotype/dose for intramuscular injection of 0.5 ml
Main outcome variables
Number of people with Solicited Adverse Drug Reactions in the first 7 days after injection (days 0-6)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201104049265N2
Registration date:2021-09-15, 1400/06/24
Registration timing:registered_while_recruiting
Last update:2021-09-15, 1400/06/24
Update count:0
Registration date
2021-09-15, 1400/06/24
Registrant information
Name
Seyyedeh Maryam Afshani
Name of organization / entity
Arta Zist Pharmed
Country
Iran (Islamic Republic of)
Phone
+98 21 8609 2503
Email address
m.afshani@artapharmed.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-15, 1400/06/24
Expected recruitment end date
2021-10-16, 1400/07/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety evaluation of a quadrivalent recombinant influenza vaccine (serotypes of 2021/2022) manufactured by Nivad Pharmed Salamat, open label, single arm, in volunteers aged ≥ 18 years.
Public title
Safety evaluation of quadrivalent recombinant influenza vaccine (serotypes of 2021/2022), open label, single arm, in volunteers aged ≥ 18 years.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Aged ≥ 18 years
Able to provide written informed consent
Subject is willing to comply with the study visits
Healthy subjects or patients with stable concomitant diseases (the underlying disease is controlled and there is no need for hospitalization)
Exclusion criteria:
Subject is currently participating or is planning to participate in another clinical trial in 1 month
Females of childbearing age with confirmed or suspected pregnancy, those planning on conceiving during the trial duration and women who are breastfeeding
Fever at the time of entry (temperature > 38 measured by remote thermometer)
Having an active infection with clinical signs of Covid-19 such as fever or chills, cough, fatigue, headache, shortness of breath, sore throat, change in sense of smell or taste, or any other warning signs of infection within 72 hours before injection (If a person has already had the disease and has recovered, participation in the study is not prohibited.)
History of severe allergy to any type of vaccine (anaphylactic shock)
History of Guillain-Barré or other demyelinating diseases
Covid-19 vaccination at least 2 weeks before participation
Planning to receive Covid-19 vaccine for at least the next 2 weeks according to the national vaccination protocol
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
1000
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran National Committee for Ethics in Biomedical Research
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
2021-09-13, 1400/06/22
Ethics committee reference number
IR.NREC.1400.008
Health conditions studied
1
Description of health condition studied
Influenza due to certain identified influenza viruses
ICD-10 code
J09
ICD-10 code description
J09
Primary outcomes
1
Description
Number of participants with Solicited Local and Systemic Adverse Drug Reactions in the first 7 days after injection (days 0-6)
Timepoint
days 0-6
Method of measurement
number of participants
2
Description
Number of participants with Unsolicited Adverse Events in the first 7 days after injection (days 0-6)
Timepoint
days 0-6
Method of measurement
number of participants
3
Description
Number of participants with vasovagal syncope in the first 7 days after injection (day 0-6) based on VAERS
Timepoint
days 0-6
Method of measurement
number of participants
4
Description
Number of participants with fever (any, Grade 3, related) in the first 7 days after injection (days 0-6)
Timepoint
days 0-6
Method of measurement
number of participants
Secondary outcomes
1
Description
Unsolicited Adverse Events 7 to 14 days after vaccination
Timepoint
Days 7 to 14
Method of measurement
number of participants
2
Description
Number of participants with Adverse Events of Special Interest (AESIs) 42 days after injection
Timepoint
Day 42
Method of measurement
number of participants
3
Description
Number of participants with Medically Attended Adverse Events (MAEs) in 14 days after injection
Timepoint
days 0 to 14
Method of measurement
number of participants
4
Description
Number of participants with SAEs
Timepoint
Throughout the study
Method of measurement
number of participants
5
Description
Number of seroconverted subjects for Hemagglutination Inhibition Antibodies assay against 4 strains of influenza on day 28 after vaccination
Timepoint
day 28
Method of measurement
number of participants
Intervention groups
1
Description
Intervention group: pre-filled syringe of Fluguard quadrivalent flu vaccine containing strains of 2021-2022, 45μg HA/ serotype/dose for intramuscular injection of 0.5 ml