Active Pharmacovigilance Study of Adsorbed COVID-19 (Inactivated) Vaccine

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Active Pharmacovigilance Study of Post-vaccine Adverse Events of Sinovac's/ Butantan Institute Adsorbed COVID-19 (Inactivated) Vaccine

Conditions
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SARS-CoV-2 Acute Respiratory Disease

Intervention / Treatment
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* Biological: Adsorbed COVID-19 (Inactivated) Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult allowed to receive the Adsorbed COVID-19 (inactivated) Vaccine according to the Immunization National Plan. Informed consent form signed by participant. Show voluntary intention to participate in the study and availability throughout the study. Exclusion Criteria: History of severe allergic reactions or anaphylaxis to previous vaccines or allergy to any components of the study vaccine. History of fever (axillar temperature ≥ 37,8º C) 72 hours before the vaccine Be unavailable during the study period. Any other condition that, in the opinion of the principal investigator or his/her representative physician, could put the safety/rights of potential participants at risk or prevent them from complying with this protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Health care professionals between 18 and 59 years old<br>Health care professionals | Biological: Adsorbed COVID-19 (Inactivated) Vaccine<br>* Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute<br>|
| General population 75 years old or more<br>Elderly 75y plus | Biological: Adsorbed COVID-19 (Inactivated) Vaccine<br>* Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute<br>|
| General population 60 and 74 years old<br>Elderly between 60-74y | Biological: Adsorbed COVID-19 (Inactivated) Vaccine<br>* Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Adsorbed COVID-19 vaccine (inactivated), Pharmacovigilance