Trials / Completed
CompletedNCT04845048
Active Pharmacovigilance Study of Adsorbed COVID-19 (Inactivated) Vaccine
Active Pharmacovigilance Study of Post-vaccine Adverse Events of Sinovac's/ Butantan Institute Adsorbed COVID-19 (Inactivated) Vaccine
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,549 (actual)
- Sponsor
- Butantan Institute · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Adsorbed COVID-19 (Inactivated) Vaccine | Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute |
Timeline
- Start date
- 2021-05-10
- Primary completion
- 2023-03-12
- Completion
- 2023-03-13
- First posted
- 2021-04-14
- Last updated
- 2023-05-22
Locations
3 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT04845048. Inclusion in this directory is not an endorsement.