IRCT20171122037571N4
Completed
Phase 3
A Clinical trial to evaluate the immunogenicity and safety of Omicron-Based CovIran Barkat vaccine as a third injection dose in vaccinated population over 18 years of age
SHIFAPHARMED Industrial Group Co0 sites210 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- SHIFAPHARMED Industrial Group Co
- Enrollment
- 210
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged over 18 years old
- •In the volunteer’s vaccination history, the interval between the first and second dose is between 4 to 8 weeks and at least 3 months and at most 5 months have passed since the injection of the second dose of the volunteer's vaccination.
- •The volunteer must be able and willing to cooperate with the researchers throughout the study period.
- •The volunteer must be able to fully understand the executive processes of the study and to understand the explanations of the facilitators correctly.
- •The volunteer would be able to understand the contents of the informed consent form and sign the informed consent before recruitment.
- •Access to the medical records and test results if hospitalised for any reason including due to the suspected or confirmed COVID\-19 should be allowed.
- •The volunteer has been in a medically stable condition for the past three months (he/she has not been hospitalized, his / her chronic illness has not recurred). His / her chronic illness medication instructions have not changed due to lack of control over clinical symptoms, etc.)
Exclusion Criteria
- •Confirmed, suspected, or asymptomatic COVID\-19 case
- •Candidate with a history of SARS\-CoV\-2 infection (documented rtPCR) after receiving the second dose of COVID\-19 vaccine.
- •During the period of home quarantine due to Covid\-19 (suspicion of exposure or suspicious symptoms).
- •In the 14 days prior to vaccination: fever or presence of at least two symptoms from Dry cough, severe fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhoea, dyspnea, and shortness of breath
- •History of severe allergic reaction, urticaria or allergic reactions to COVID\-19 Inactivated vaccine ingredients (allergic to Aluminium).
- •Personal or family history of seizure, epilepsy, encephalopathy or psychiatric disorders
- •Presence of congenital malformations or any genetic disorder
- •Presence of any malignancy
- •Known case of immunodeficiency, HIV, lymphoma, leukemia, or other autoimmune diseases.
- •Receiving immunosuppressive drugs or corticosteroids in the last 6 months
Outcomes
Primary Outcomes
Not specified
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