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| ID | Type | Description | Link |
|---|---|---|---|
| Instituto Butantan | Other Identifier | Fundação Butantan |
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This is a prospective cohort study, observational, multicentre, single-arm, post-registration to assess the safety of the Adsorbed COVID-19 (Inactivated) Vaccine Sinovac / Institute Butantan.
. This is a prospective cohort study, observational, multicentre, single-arm, post-registration to assess the safety of the Adsorbed COVID-19 (Inactivated) Vaccine Sinovac / Institute Butantan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health care professionals between 18 and 59 years old | Health care professionals |
| |
| General population 75 years old or more | Elderly 75y plus |
| |
| General population 60 and 74 years old | Elderly between 60-74y |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adsorbed COVID-19 (Inactivated) Vaccine | Biological | Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions. | Frequency of solicited and non-solicited local and systemic adverse reactions according to age group and severity. | 7 days after each dose of the vaccine |
| Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of participants who presented adverse reactions according to the age group | Frequency of participants who presented any solicited and non-solicited local and systemic adverse reactions according to age group and severity. | 7 days after each dose of the vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions which needed medical care in participants >= 18 years. | Frequency of solicited and non-solicited local and systemic adverse reactions, which required medical care according to the dose and severity. | 42 days after any dose of the vaccine |
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Inclusion Criteria:
Exclusion Criteria:
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The population groups included in this study are the categories that have indication of immunization, defined by the national vaccination plan for COVID-19: health care professionals between 18 and 59 years old and elderly participants 60 aged or over
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| Name | Affiliation | Role |
|---|---|---|
| Marta H Lopes, MD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Saúde Escola da Faculdade de Medicina de Botucatu - Unesp. | Botucatu | São Paulo | Brazil | |||
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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 |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions which required medical care in participants < 18 years. |
Frequency of solicited and non-solicited local and systemic adverse reactions, which required medical care according to the dose and severity. |
| 365 days after the second dose of the vaccine. |
| Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions. | Frequency of solicited and non-solicited local and systemic adverse reactions according to the dose, severity and age group. | First 30 minutes after each dose of the vaccine. |
| Incidence of serious adverse event (AE) | Incidence of serious adverse event | The whole period of study (365 days after the second dose) |
| Description of medications used after adverse event (AE) | Description of medications and duration used after adverse event | The whole period of study (365 days after the second dose) |
| Incidence of adverse event of special interest (AESI) | Incidence of adverse event of special interest | The whole period of study (365 days after the second dose) |
| Incidence of serious adverse event if a subject get pregnant (SAE) | Incidence of serious adverse event if a subject get pregnant after received any dose of the vaccine | From the recrod of pregnancy until the end of the study or upto the birth. |
| Centro de Saúde Escola da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP-USP) Dr. Joel Domingos Machado. |
| Ribeirão Preto |
| São Paulo |
| Brazil |
| Centro de Referência de Imunobiológicos Especiais. Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (CRIEHCFMUSP) | São Paulo | Brazil |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |