IRCT20171122037571N3
Recruiting
Phase 1
Comparison of the tolerability, safety, and immunogenicity of Shifa-Pharmed COVID-19 inactivated vaccine (CovIran) and Sinopharm vaccine in the healthy population aged 12 to 18 years: a double-blind, randomized, active-controlled, Phase I-II clinical trial.
SHIFAPHARMED Industrial Group Co0 sites500 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- SHIFAPHARMED Industrial Group Co
- Enrollment
- 500
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 12 to 18 years
- •According to the protocol, the volunteer and their legal guardian be able and willing to cooperate with the researchers throughout the study period.
- •The volunteer and/or their legal guardian are able to fully understand the executive processes of the study and to understand the explanations of the facilitators correctly.
- •The volunteer and/or their legal guardian are able to understand the contents of the informed consent form and sign the informed consent before interring in the study.
- •The volunteer and/or their legal guardian allow the researchers to access medical records and test results if hospitalised for any reason including due to the suspected or confirmed COVID\-19\.
- •Healthy general condition according to medical history and initial medical examinations.
- •BMI of higher than 3rd percentile according to WHO standards for child growth at visit day (day 0\).
- •Volunteers and their legal guardians agree not to donate blood, blood products, or bone marrow from the time of vaccine inoculation until 3 months after receiving the last dose of the vaccine
- •Women with fertility potential: Negative pregnancy test on the first day of injection (day zero) and day of the second injection (day 28\). Furthermore, volunteers should use the effective contraception method 28 days before the first dose and continue to use it for at least three months after the second dose.
Exclusion Criteria
- •Confirmed, suspected, or asymptomatic COVID\-19 detected by PCR at baseline.
- •Positive Neutralizing antibody or COVID\-19 nucleocapsid antibody (N\-protein) on the day of the screening visit.
- •History of SARS\-CoV\-2 infection (documented rtPCR)
- •History of contact with a person with SARS\-CoV\-2 infection (positive PCR test) during the last 14 days
- •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
- •Abnormality in biochemistry, blood and urine laboratory tests prior to vaccination(biochemistry including Na, K, BUN/Urea, creatinine, FBS, Liver function tests: AST, ALT, ALP, total bilirubin, CBC: leukocyte count, Hemoglobin, platelet, neutrophil. lymphocyte, urine analysis: protein, glucose and blood cells (Microscopic examination).
- •History of severe allergy, urticaria or allergic reactions to COVID\-19 Inactivated vaccine ingredients (allergic to Aluminium).
- •Personal or family history of seizure, epilepsy, encephalopathy or mental disorders, Congenital malformations, History of neurologic disorders or seizure (excluding febrile seizure).
- •Any genetic disorder.
Outcomes
Primary Outcomes
Not specified
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