Safety and Immunogenicity of Razi Cov-2 recombinant Spike protein vaccine (RAZI Cov Pars) in healthy children and adolescents aged 5-17 years

Phase 1

Recruiting

• Conditions: SARS-CoV-2.; COVID-19; U07.1

• Registration Number: IRCT20201214049709N5
• Lead Sponsor: Razi Vaccine and Serum Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 420

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

Study & Design

• Study Type: interventional
• Study Design: Not specified