This study is a global multi-center , case-driven, randomized, double-blinded, and placebo-controlled phase Ⅲ clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the efficacy of two dose of CoronaVac® against RT-PCR confirmed symptomatic COVID-19 cases in participants aged 6 months to 17 years.
This study is a global multi-center , case-driven, randomized, double-blinded, and placebo-controlled phase Ⅲ clinical trial in participants aged 6 months to 17 years.The purpose of this study is to evaluate the efficacy of two dose of CoronaVac® against RT-PCR confirmed symptomatic COVID-19 cases in participants aged 6 months to 17 years.The experimental vaccine and placebo were both manufactured by Sinovac Research \& Development Co., Ltd. A total of 14,000 healthy participants aged 6 months to 17 years will be enrolled, and randomly assigned into 2 groups at a ratio of 1:1 to receive 2 doses of experimental vaccine (600SU) or placebo with an interval of 28 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
11,349
The inactivated COVID-19 vaccine was manufactured by Sinovac Research\& Development Co., Ltd..600SU Inactivated SARS-COV-2 virus in 0·5 mL of aluminium hydroxide solution per injection
The placebo was manufactured by Sinovac Research\& Development Co., Ltd.The composition is aluminium hydroxide,The appearance of the placebo is consistent with the vaccine, which is a milky-white suspension.
Efficacy index-incidence of RT-PCR confirmed symptomatic COVID-19 cases with onset
Incidence of RT-PCR confirmed symptomatic COVID-19 cases with onset at least 14 days after the second dose
Time frame: 14 days after the second dose
Efficacy index-incidence of RT-PCR confirmed symptomatic COVID-19 cases with onset
Incidence of RT-PCR confirmed symptomatic COVID-19 cases with onset at least 14 days after the first dose
Time frame: 14 days after the first dose
Efficacy index-incidence of RT-PCR confirmed, symptomatic COVID-19 cases with onset in SARS-CoV-2 uninfected participants
Incidence of RT-PCR confirmed, symptomatic COVID-19 with onset at least 14 days after the second dose in SARS-CoV-2 uninfected (serologically or molecularly confirmed) participants at baseline
Time frame: 14 days after the second dose
Efficacy index-incidence of hospitalization/severe/death caused by COVID-19 with onset
Incidence of hospitalization/severe/death caused by COVID-19 with onset at least 14 days after the second dose
Time frame: 14 days after the second dose
Safety index-occurrence, intensity, duration, and relationship of solicited local and systemic AEs and of unsolicited AEs
Occurrence, intensity, duration, and relationship of solicited local and systemic AEs during 7 days following each dose vaccination and of unsolicited AEs during 28 days post-vaccination
Time frame: During 7 days following each dose vaccination and during 28 days post-vaccination
Safety index-occurrence and relationship of SAEs
Occurrence and relationship of SAEs from first dose to 12 months after the last dose
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Hospital de Puerto Montt
Port Montt, Los Lagos Region, Chile
Clínica Alemana Valdivia
Valdivia, Los Ríos Region, Chile
Hospital Universidad Clinico de Antofagasta
Antofagasta, Santiago Metropolitan, Chile
Hospital Roberto del Río
Independencia, Santiago Metropolitan, Chile
Clínica San Carlos de Apoquindo
Las Condes, Santiago Metropolitan, Chile
Clínica Universidad de los Andes
Las Condes, Santiago Metropolitan, Chile
San Joaquín
Macul, Santiago Metropolitan, Chile
Hospital Sótero del Río
Puente Alto, Santiago Metropolitan, Chile
Hospital Ezequial Gonzalez
San Miguel, Santiago Metropolitan, Chile
Marcoleta
Santiago, Santiago Metropolitan, Chile
...and 28 more locations
Time frame: From first dose to 12 months after the last dose
Safety index-occurrence and relationship of AESI
Occurrence and relationship of AESI from first dose to 12 months after the last dose
Time frame: From first dose to 12 months after the last dose
Immunogenicity index(subgroup)-SARS-CoV-2 neutralizing antibody titers
Analysis of SARS-CoV-2 neutralizing antibody titers by micro-cytopathic method to compare with the placebo group
Time frame: From first dose to 12 months after the last dose
Immunogenicity index(subgroup)-Anti-SARS-CoV-2 S
Analysis of Anti-SARS-CoV-2 S by electrochemiluminescence immunoassay to compare with the placebo group
Time frame: From first dose to 12 months after the last dose