This is a stepped-wedge cluster randomized trial to assess effectiveness of Sinovac's Adsorbed COVID-19 (Inactivated) vaccine. Residents in the urban area of a municipality are eligible to participate. The city was divided in clusters and those cluster were grouped to determine the offer of vaccination in four steps. The vaccine will be offered to adults (18 years old and above) according to the location of their homes in a cluster. The vaccine schedule is two doses with four-weeks interval. Baseline samples to determine previous immunity will be collected before vaccination. Cases of COVID-19 reported in the city will be recorded according to the WHO clinical progression scale. Comparison of periods before and after vaccination and relation to immunization coverage will be considered for the assessment of effectiveness in the clusters and groups of clusters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
27,711
Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac
Hospital Estadual de Serrana
Serrana, São Paulo, Brazil
Incidence of COVID-19 cases after two-doses immunization schedule in clusters in the first quarter of study
Number of virologically-confirmed symptomatic COVID-19 six weeks after beginning of study vaccination up to thirteen weeks
Time frame: Thirteen weeks after the beginning of study vaccination
Incidence of COVID-19 cases after two-doses immunization schedule in clusters up to one year of study
Number of virologically-confirmed symptomatic COVID-19 six weeks after beginning of study vaccination up to one year
Time frame: One year after the beginning of study vaccination
Incidence of COVID-19 cases after two-doses immunization schedule in clusters according to immunization status
Number of virologically-confirmed symptomatic COVID-19 six weeks after beginning of study vaccination up to one year according to immunization status
Time frame: One year after the beginning of study vaccination
Incidence of COVID-19 cases after two-doses immunization schedule in clusters according to pre-existing SARS-CoV-2 antibodies
Number of virologically-confirmed symptomatic COVID-19 six weeks after beginning of study vaccination up to one year according to pre-existing SARS-CoV-2 antibodies
Time frame: One year after the beginning of study vaccination
Incidence of COVID-19 cases after two-doses immunization schedule in clusters according to immunization coverage
Number of virologically-confirmed symptomatic COVID-19 six weeks after beginning of study vaccination up to one year according to immunization coverage
Time frame: One year after the beginning of study vaccination
Incidence of hospitalization and death due to COVID-19 after two-doses immunization schedule in clusters
Number of hospitalization and death due to COVID-19 six weeks after beginning of study vaccination up to one year
Time frame: One year after the beginning of study vaccination
Change in average number of reported COVID-19 cases in the study area in comparison to other neighboring cities
Average number of reported COVID-19 cases in the microregion where the study area is located
Time frame: One year after the beginning of study vaccination
Medically-attended adverse reactions to the study vaccine
Number of medically-attended adverse reactions to the study vaccine
Time frame: One week after each vaccination
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
Acceptability of the study vaccine
Acceptability rate of the study vaccine in the eligible population of each cluster
Time frame: Two weeks after the beginning of study vaccination of the corresponding cluster
Adherence to vaccination schedule
Adherence rate to vaccination schedule in the population of each cluster
Time frame: Six weeks after the beginning of study vaccination of the corresponding cluster
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