IRCT20201214049709N6
Completed
未知
Immunogenicity and Safety of intranasal Razi Cov Pars as a booster dose in adult population; randomised, double blind, placebo controlled clinical trial
Razi Vaccine and Serum Research Institute0 sites206 target enrollmentStarted: TBDLast updated:
Overview
- Phase
- 未知
- Status
- Completed
- Sponsor
- Razi Vaccine and Serum Research Institute
- Enrollment
- 206
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to no limit (—)
- Sex
- All
Inclusion Criteria
- •Having Iranian citizenship or in the case of foreign nationals with a legal residence permit
- •Age 18 years and older
- •History of full vaccination with one of the following vaccines: Sinopharm, Razi Cov Pars, Pastocovac, Spikogen, AstraZeneca, Fakhra, or Barkat at least 5 months before the study
- •5 months interval between the last vaccine dose and the current study participation
- •In the last six months, the person has not had a confirmed Covid\-19 disease based on laboratory evidence or confirmed by a physician
- •Signing a written informed consent form
- •Using at least one reliable contraceptive method (condom, oral contraceptive pills, intrauterine contraceptive device, IUD, Norplant capsule) for women of reproductive age 18 to 49 years until 3 months after receiving the booster dose
- •Negative pregnancy test (baby check) on the day of vaccination
Exclusion Criteria
- •History of allergic reactions after receiving any previous Covid\-19 vaccines or any other drug or vaccine
- •Having any acute or chronic illness requiring continuous ongoing medical or surgical care within the last months
- •History of severe cardiovascular disease such as heart failure, or hospitalization due to heart disease within the last year
- •Pregnancy declared by the participant based on the first day of the last menstrual period (LMP)
- •Breastfeeding
- •History of receiving any vaccine within 14 days of receiving the intranasal booster dose
- •Received blood and/or any blood products and/or immunoglobulins within three months prior to the intranasal booster dose
- •Diagnosed (suspected or confirmed) with immunocompromising illneses, history of long\-term use of immunosuppressive drugs, including history of long\-term use of systemic corticosteroids equivalent to 10 mg or more daily prednisolone for more than 14 consecutive days with the exception of topical steroids within the last 4 months
- •Recent diagnosis or treatment of cancers except basal cell carcinoma and In\-situ cervical cancer
- •History of uncontrolled serious psychiatric illnesses
Investigators
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