This is a phase III clinical trial to assess efficacy and safety of the Adsorbed COVID-19 (inactivated) vaccine manufactured by Sinovac in health care professionals
This is a phase III clinical trial to assess efficacy and safety of the Adsorbed COVID-19 (inactivated) vaccine manufactured by Sinovac in health care professionals. The study will be double-blind placebo-controlled trial with participants randomly allocated 1:1 to placebo and vaccine arms. The immunization schedule is two doses intramuscular injections (deltoid) with a 14-days interval. For efficacy, the study aims to detect COVID-19 cases, defined as symptomatic SARS-CoV-2 infections, after the second week post-immunization schedule. For safety and immunogenicity, participants are categorized in two age groups, Adults (18-59 years) and Elderly (60 years and above). Safety database aims to detect adverse reactions with frequency of 1:1000 or higher in adults and 1:500 in elderly. All participants will be followed up to 12 months. Interim preliminary efficacy analysis can be triggered by reaching the target number of 61 cases. Primary efficacy analysis requires 151 cases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
12,688
Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac
Placebo of Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac
Universidade de Brasília
Brasília, Federal District, Brazil
Hospital Universitário Maria Aparecida Pedrossian
Incidence of COVID-19 cases after two-doses immunization schedule
Number of virologically-confirmed symptomatic COVID-19 two weeks after second dose of vaccine
Time frame: Two weeks after second dose up to one year after first dose
Frequency of adverse events up to seven days after immunization
Frequency of adverse reaction in the seven days following each immunization per age group
Time frame: Seven days after each immunization
Incidence of COVID-19 cases after two-doses immunization schedule according to previous exposure
Number of virologically-confirmed symptomatic COVID-19 two weeks after second dose of vaccine according to previous exposure to SARS-CoV-2
Time frame: Two weeks after first dose up to one year after first dose
Incidence of COVID-19 cases after 14-days of first immunization
Number of virologically-confirmed symptomatic COVID-19 two weeks after first dose of vaccine, regardless the vaccination schedule was completed
Time frame: Two weeks after last dose uup to one year after first dose
Combined incidence of SARS-CoV-2 infection
Number of virologically-confirmed and or serologically-confirmed SARS-CoV-2 infections two weeks after first dose of vaccine
Time frame: Two weeks after second dose up to one year after first dose
Incidence of severe COVID-19 cases after two-doses immunization schedule
Number of virologically-confirmed severe COVID-19 two weeks after second dose of vaccine
Time frame: Two weeks after second dose up to one year after first dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Campo Grande, Mato Grosso do Sul, Brazil
Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Hospital Universitário Júlio Müller
Cuiabá, Mount, Brazil
Hospital das Clínicas da Universidade Federal do Paraná
Curitiba, Paraná, Brazil
Hospital Escola da Universidade Federal de Pelotas
Pelotas, Rio Grande do Sul, Brazil
Hospital São Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Amor - Fundação Pio XII
Barretos, São Paulo, Brazil
Hospital das Clínicas da UNICAMP
Campinas, São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, Brazil
...and 6 more locations
Frequency of adverse events up to 28 days after immunization
Frequency of adverse reaction in the 28 days following each immunization per age group
Time frame: 28 days after each immunization
Frequency of severe COVID-19 cases
Frequency of virologically-confirmed severe COVID-19 cases after receiving, at least, one dose of the vaccine
Time frame: From first vaccination up to one year after first dose
Frequency of adverse events of special interest after immunization
Frequency of adverse events of special interest after receiving, at least, one dose of the vaccine
Time frame: From first vaccination up to one year after first dose
Seroconversion rate
Number of seroconversion responses to SARS-CoV-2 in the second week after each vaccination per age group in a subset of participants
Time frame: Two weeks after each vaccination
Cell-mediated immune profile
Number of cell-mediated immune response against SARS-CoV-2 in the week two and four after the second vaccination per age group in a subset of participants
Time frame: Two and four weeks afer each vaccination
Seropositivity rate
Number of seropositive responses to SARS-CoV-2 in the second week after each vaccination per age group in a subset of participants
Time frame: Two weeks after second vaccination