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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2549 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-10

Study Completion Date

2023-03-13

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.

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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.

Conditions

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SARS-CoV-2 Acute Respiratory Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Health care professionals between 18 and 59 years old

Health care professionals

Adsorbed COVID-19 (Inactivated) Vaccine

Intervention Type BIOLOGICAL

Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute

General population 75 years old or more

Elderly 75y plus

Adsorbed COVID-19 (Inactivated) Vaccine

Intervention Type BIOLOGICAL

Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute

General population 60 and 74 years old

Elderly between 60-74y

Adsorbed COVID-19 (Inactivated) Vaccine

Intervention Type BIOLOGICAL

Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute

Interventions

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Adsorbed COVID-19 (Inactivated) Vaccine

Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute

Intervention Type BIOLOGICAL

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes