This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose. The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. All subjects will be followed for 12 months. INAVAC is an inactivated vaccine made of SARS-CoV-2 virus isolated from a patient in Surabaya, composed with aluminium hydroxy gel, tween 80, and L-histidine, and this study will be the first phase III in adolescents.
This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose. The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. All subjects will be followed for 12 months. This study will have three interim and one full analysis The main focus is immunogenicity and safety or reactogenicity issues. Data Safety Monitoring Board will be commissioned for this study to evaluate safety data over the study period and to review any events that meet a specific study pausing rule or any other safety issue that may arise. They will review the 7 and 28 days safety data following the first dose of vaccine, and then the 7 and 28 days after the second dose. The immunogenicity data will be evaluated until 12 months after the second dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
400
Dose : 1 dose 0.5 ml containing 5 µg inactivated SARS-CoV-2 virus, Tween 80, histidine, Polysorbate 80, Aluminium hydroxide gel, and sodium chloride.
Dr. Soetomo General Hospital
Surabaya, East Java, Indonesia
RECRUITINGVaccine Neutralizing Antibody Profile
SARS-CoV-2 neutralizing titers in serum measured by a virus neutralization assay, at 28 days after two doses vaccination of INAVAC in healthy adolescents age 12 to 17 years old, compared with previous results in adults with two doses of similar vaccine (phase 3 in adults).
Time frame: 28 days after two doses vaccination of INAVAC.
Incidence of Adverse Events
1. Solicited - clinical (local and systemic) adverse events for 30 minutes, 24 hours, 7 and 28 days after the first and second vaccination, and then 3, 6, and 12 months after the second injection of INAVAC in healthy adolescents age 12 to 17 years old, compared with previous results in adults with two doses of similar vaccine (phase 3 in adults). 2. Unsolicited adverse events for 30 minutes, 24 hours, 7 and 28 days after the first and second vaccination, and then 3, 6, and 12 months after the second injection of INAVAC in healthy adolescents age 12 to 17 years old, compared with previous results in adults with two doses of similar vaccine (phase 3 in adults). 3. Serious adverse event (SAE) throughout the study (from the first vaccination).
Time frame: 30 minutes, 24 hours, 7 and 28 days following the first dose and 30 minutes, 24 hours, 7 and 28 days, 3, 6 and 12 months after the second doses of INAVAC
Humoral Immunogenicity - The Neutralizing Antibody Titers in Serum
Evaluate SARS-Cov-2 neutralizing titers in serum measured by virus neutralization assay at 3, 6, and 12 months, following vaccination with two doses of INAVAC in healthy adolescents age 12 to 17 years old, compared with previous results in adults with two doses of similar vaccine (phase 3 in adults).
Time frame: 3, 6, and 12 months, following vaccination with two doses of INAVAC
Humoral Immunogenicity - Levels of SARS-CoV-2 Binding Antibodies by CLIA
SARS-CoV-2 binding antibodies measured by CLIA: analysis of antibodies binding to the SARS-CoV-2 S-protein.
Time frame: 28 days, 3, 6, and 12 months after the second vaccination of INAVAC
Cellular Immunogenicity Profile
1. Th1 immune responses assessed by Flow cytometri 2. Th2 immune responses assessed by Flow cytometri
Time frame: 28 days, 3, 6, and 12 months, following vaccination with two doses of INAVAC
Persistence of Antibody Level
Evaluate the persistence of antibody level over time for 12 months after second injection.
Time frame: 12 months after the second injection
Whole Genome Sequencing (WGS) of SARS-CoV-2
Whole genome sequencing (WGS) of S protein of SARS-CoV-2 virus from all positive Covid-19 cases
Time frame: Throughout the study, an average of 1 year
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