SARS-CoV-2 Acute Respiratory Disease
Conditions
Keywords
COVID-19, Adsorbed COVID-19 vaccine (inactivated), Pharmacovigilance
Brief summary
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
. 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.
Interventions
BIOLOGICALAdsorbed COVID-19 (Inactivated) Vaccine
Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute
Sponsors
Butantan Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions. | 7 days after each dose of the vaccine | Frequency of solicited and non-solicited local and systemic adverse reactions according to age group and severity. |
| Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of participants who presented adverse reactions according to the age group | 7 days after each dose of the vaccine | Frequency of participants who presented any solicited and non-solicited local and systemic adverse reactions according to age group and severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions. | First 30 minutes after each dose of the vaccine. | Frequency of solicited and non-solicited local and systemic adverse reactions according to the dose, severity and age group. |
| Incidence of serious adverse event (AE) | The whole period of study (365 days after the second dose) | Incidence of serious adverse event |
| Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions which needed medical care in participants >= 18 years. | 42 days after any dose of the vaccine | Frequency of solicited and non-solicited local and systemic adverse reactions, which required medical care according to the dose and severity. |
| Incidence of adverse event of special interest (AESI) | The whole period of study (365 days after the second dose) | Incidence of adverse event of special interest |
| Incidence of serious adverse event if a subject get pregnant (SAE) | From the recrod of pregnancy until the end of the study or upto the birth. | Incidence of serious adverse event if a subject get pregnant after received any dose of the vaccine |
| Description of medications used after adverse event (AE) | The whole period of study (365 days after the second dose) | Description of medications and duration used after adverse event |
| Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions which required medical care in participants < 18 years. | 365 days after the second dose of the vaccine. | Frequency of solicited and non-solicited local and systemic adverse reactions, which required medical care according to the dose and severity. |
Countries
Brazil
Outcome results
None listed