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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First group of clusters | Experimental | Adsorbed COVID-19 (Inactivated) vaccine offered in the first week of study The vaccine is administrated in two doses with a four-weeks interval |
|
| Second group of clusters | Experimental | Adsorbed COVID-19 (Inactivated) vaccine offered in the second week of study The vaccine is administrated in two doses with a four-weeks interval |
|
| Third group of clusters | Experimental | Adsorbed COVID-19 (Inactivated) vaccine offered in the third week of study The vaccine is administrated in two doses with a four-weeks interval |
|
| Fourth group of clusters | Experimental | Adsorbed COVID-19 (Inactivated) vaccine offered in the fourth week of study The vaccine is administrated in two doses with a four-weeks interval |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adsorbed COVID-19 (Inactivated) Vaccine | Biological | Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Thirteen weeks after the beginning of study vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | One year after the beginning of study vaccination |
| Incidence of COVID-19 cases after two-doses immunization schedule in clusters according to immunization status |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of SARS-CoV-2 variants in the study area | Description of SARS-CoV-2 variants sequenced out of the samples collected in the study area | One year after the beginning of study vaccination |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernanda Boulos, MD, MSc | Butantan Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Estadual de Serrana | Serrana | São Paulo | 14150-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41714650 | Derived | Borges MC, Palacios R, Conde MTRP, Volpe GJ, Ferreira NN, Garibaldi PMM, Fonseca BAL, Calado RT, Coutinho BM, Gomes BBM, de Lima Dias CFS, de Moraes GR, Haddad SK, de Miranda EJFP, Braga PE, Ragiotto L, Franca JID, de Lima MA, de Oliveira Alves LB, de Camargo Vieira Tenorio J, Sampaio SC, Covas DT, Dos Santos Almeida MAAL, Morandi Junior E, Boulos FC. Indirect protection and long-term effectiveness of inactivated COVID-19 vaccine: a stepped-wedge randomised trial in Serrana, Brazil. Sci Rep. 2026 Feb 19;16(1):9879. doi: 10.1038/s41598-026-37815-1. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| C000722216 | sinovac COVID-19 vaccine |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Groups of cluster are allocated to offer vaccination in a stepped-wedge mode.
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|
Number of virologically-confirmed symptomatic COVID-19 six weeks after beginning of study vaccination up to one year according to immunization status |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Six weeks after the beginning of study vaccination of the corresponding cluster |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |