COVID-19 trials registries data warehouse

http://en.irct.ir/trial/61378

Ali Eshaghi

a.Eshahghi@rvsri.ac.ir

2022-02-09

Completed

nonRCT

Non-randomized

Single group assignment

Open label

single-center

Prevention

Participants legal guardian should be able to read and write Age between 5-17 years Having good health based on clinical and laboratory criteria Negative RT-PCR test for COVID-19 Signed the informed consent form Not pregnant Negative beta HCG pregnancy test on screening and vaccination day Use of at least one effective method of contraception (condoms, oral contraceptive pills, intrauterine device, Norplant capsule) and willing to continue using it in female couples

Any ongoing, symptomatic acute or chronic illness requiring continuous medical or surgical care on the day of vaccination Breastfeeding Received any Covid Vaccine Received any vaccine during the 14-days period prior to the screening day Received blood and/or any blood products and/or immunoglobulins within three months preceding the screening day History of long-term use of immunosuppressive medication (defined as more than 14 consecutive days) in the last 6 months leading up to screening day Long-term use (defined as more than 14 consecutive days) of systemic corticosteroids within the past 6 months leading up to screening day History of severe allergic diseases (such as Dyspnea, angioedema, anaphylactic reactions, urticaria and eczema) History of allergy to any drug or vaccine (defined as any clinical signs or symptom of itching at the injection site, urticaria in the body after injection, excessive redness at the injection site) History of immunological disorder (congenital or acquired) History of chemotherapy in the last 5 years History of cancer in the last 5 years History of acute and serious psychiatric illnesses History of blood disorders (dyscrasia, coagulopathy, platelet deficiency or disorder, deficiency of blood factors) Severe acute or chronic renal or hepatic failure based on laboratory parameters Suffering from chronic obstructive pulmonary disease such as asthma, or severe renal/hepatic diseases requiring continuous treatment by a specialist Uncontrolled hypertension Uncontrolled Diabetes History of chronic neurological diseases (including seizures and epilepsy) Any history of substance or alcohol abuse Grade 1 or higher abnormal laboratory (hematology or biochemistry) tests based on toxicity score on the screening day History of confirmed COVID-19 diseases during the 6-months period before the screening day (positive PCR test or clinical diagnosis) Acute febrile illness at the time of vaccination History of allergy to acetaminophen Receiving prophylactic drug against tuberculosis History of faint when see blood Splenectomy for any reason Any close contact with a confirmed COVID-19 case within two weeks before the first dose of vaccine Congenital disorders, developmental disorders, severe malnutrition or genetic diseases Participating in any clinical trials (research) other than this study

1

Razi Vaccine and Serum Research Institute

5

17

Iran

Healthy volunteers

N/A

420

Abnormal vital signs and anaphylactic reactions immediately after vaccination: Number and percentages of participants who develop abnormal vital signs within half an hour of receiving the vaccine at each doses will be recorded. Abnormal vital signs include temperature, respiratory rate, heart rate, systolic and diastolic blood pressure before and after vaccination. Anaphylaxis is defined as an immediate systemic hypersensitivity simultaneously involving two systems. Anaphylactic reactions include: erythema, pruritus, urticaria and angioedema, bronchospasm, laryngeal edema, dizziness, hypotension, nausea, shortness of breath, wheezing, arrhythmia, cyanosis, vomiting, diarrhea, abdominal pain and will be checked after each vaccination. Local adverse reactions: The number and percentage of local adverse reactions within the first week post-vaccination (including pain, tenderness, erythema/redness, swelling and stiffness, itching) Systemic adverse event: The number and percentage of systemic adverse event within the first week post-vaccination (including nausea and vomiting, diarrhea, headache, fatigue, muscle pain) ََAbnormal laboratory findings: The number and percentage of people who show abnormal laboratory findings one week after vaccination (Based on toxicity scores), including biochemistry, hematology, and urine tests. These tests include: Hemoglobin, WBC, Lymphocytes, Neutrophils, Eosinophils, Platelets ESR, CRP, Sodium, Potassium, BUN, Creatinine, Alkaline phosphatase, ALT, AST, and U/A, Urine protein, Urine glucose, Urine RBC Measurement of neutralizing antibody titers to assess humoral immunity

Phase 1/Phase 2

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