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

Butantan Institute

Status

Completed

Conditions

SARS-CoV-2 Acute Respiratory Disease

Treatments

Biological: Adsorbed COVID-19 (Inactivated) Vaccine

Study type

Observational

Funder types

Other

Identifiers

NCT04845048

Instituto Butantan (Other Identifier)

CFV-01-IB

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,549 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.