Phase ?/? clinical trial of Shifa-Pharmed COVID-19 inactivated vaccine (CovIran-Barkat) among healthy adolescents aged 12 to 18 years

INTERVENTION: Intervention 1: Intervention group: Intramuscular injection (deltoid muscle) of 0.5 ml Shifa‐Pharmed inactivated vaccine (CovIran‐ Barkat) on days 0 and 28. Intervention 2: Control group: Intramuscular injection (deltoid muscle) of 0.5 ml Sinopharm vaccine on days 0 and 28. CONDITION: COVID‐19 disease. ; COVID‐19, virus identified U07.1 PRIMARY OUTCOME: Phase 1: Any immediate reaction after inoculation. Timepoint: 0‐30 minutes after inoculation. Method of measurement: Close observation. Phase 1: occurrence of any adverse event (serious or non‐serious). Timepoint: Days 0 to 7 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Phase 1: Percentage of local reactions (pain, redness, swelling, ....in injection site). Timepoint: Days 0 to 7 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Phase 1: Percentage of systemic events (fever, headache, chills, nausea, vomiting, diarrhoea, fatigue, muscle pain, arthralgia, ....). Timepoint: Days 0 to 7 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Phase 2: Anti‐Spike, Neutralizing Antibody, Anti‐RBD titres (with GMT , GMI). Timepoint: Days 0, 7, 28, 42, 90, 180, 360. Method of measurement: ELISA assay. Phase 2: Lymphocytes subset count and cytokines for determining cellular immunity. Timepoint: Days 0, 28. Method of measurement: ELISA assay. Phase 2: Percentage of seroconversion occurrence. Timepoint: Days 0, 7 , 28, 42, 90, 180, 360. Method of measurement: ELISA assay. 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, blo SECONDARY OUTCOME: Phase 1: Anti‐Spike, Neutralizing antibody, Anti‐RBD titres (with GMT, GMI). Timepoint: Days 0, 7 , 28, 42, 90, 180, 360. Method of measurement: ELISA assay. Phase 1: Any adverse events (serious or non‐serious). Timepoint: Days 0 to 28 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Phase 1: Lymphocytes subset count and cytokines for determining cellular immunity. Timepoint: Days 0, 28. Method of measurement: ELISA assay. Phase 1: Occurrence and the severity of SARS‐COV‐2 infection. Timepoint: 180 days after last inoculation. Method of measurement: Comparing confirmed COVID‐19 cases, severity status is categorised as non‐severe, severe, and critical based on the WHO diagnosis scheme. Phase 1: occurrence of any Systemic events. Timepoint: Days 0 to 28 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Phase 1: seroconversion occurrence. Timepoint: Days 0, 7 , 28, 42, 90, 180, 360. Method of measurement: ELISA assay. Phase 2: Any adverse events (serious or non‐serious). Timepoint: Days 0 to 28 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Phase 2: Any immediate reaction after inoculation. Timepoint: 0‐30 minutes after inoculation. Method of measurement: Close observation. Phase 2: Local reactions in injection site (pain, redness, swelling, ....). Timepoint: Days 0 to 7 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Phase 2: Occurrence and the severity of SARS‐COV‐2 infection. Timepoint: 180 days after last inoculation. Method of measurement: Comparing confirmed COVID‐19 cases, severity status is categorised as non‐severe, severe, and critical based on the WHO diagnosis scheme. Phase 2: Percentage of systemic reactions (fever, headache, chills, nausea, vomiting, diarrhea, fatigue, myalgia, arthralgia, ....). Timepoint: Days 0 to 28 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System.