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. * The immunization schedule is two doses intramuscular injections (deltoid) with a 14-28 days interval. * There will be 900 participants (300 health care professionals between 18 and 59 years old); 300 participants 75 years old or more; 300 participants between 60 and 74 years old. All participants must be allowed to receive the Adsorbed COVID-19 (inactivated) Vaccine according to the Brazilian Immunization National Plan. * For safety analysis , the incidence of adverse events after receiving the Adsorbed COVID-19 (inactivated) Vaccine that needed health assistance until 42 days after two-doses immunization schedule. * The total period of participation in the study will be approximately 60 days after completing the two-dose schedule of the vaccine. * Active pharmacovigilance studies are essential to assess the safety profile of the vaccine in subgroups that will be included as target populations in the Immunization Program.
Study Type
OBSERVATIONAL
Enrollment
2,549
Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute
Centro de Saúde Escola da Faculdade de Medicina de Botucatu - Unesp.
Botucatu, São Paulo, Brazil
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
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.
Time frame: 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.
Time frame: 7 days after each dose of the vaccine
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.
Time frame: 42 days after any dose of the vaccine
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.
Time frame: 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.
Time frame: First 30 minutes after each dose of the vaccine.
Incidence of serious adverse event (AE)
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Incidence of serious adverse event
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From the recrod of pregnancy until the end of the study or upto the birth.