Safety and Immunogenicity of Razi Cov-2 recombinant Spike protein vaccine (RAZI Cov Pars) in healthy children and adolescents aged 5-17 years; single group, open label study

Inclusion criteria:

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

Exclusion criteria:

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

Target sample size: 420