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An Effectiveness Study of the Sinovac's Adsorbed COVID-19 (Inactivated) Vaccine

NCT04747821 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27711

Last updated 2024-02-15

No results posted yet for this study

Summary

This is a stepped-wedge cluster randomized trial to assess effectiveness of Sinovac's Adsorbed COVID-19 (Inactivated) vaccine. Residents in the urban area of a municipality are eligible to participate. The city was divided in clusters and those cluster were grouped to determine the offer of vaccination in four steps. The vaccine will be offered to adults (18 years old and above) according to the location of their homes in a cluster. The vaccine schedule is two doses with four-weeks interval. Baseline samples to determine previous immunity will be collected before vaccination.

Cases of COVID-19 reported in the city will be recorded according to the WHO clinical progression scale. Comparison of periods before and after vaccination and relation to immunization coverage will be considered for the assessment of effectiveness in the clusters and groups of clusters.

Conditions

  • Covid19

Interventions

BIOLOGICAL

Adsorbed COVID-19 (Inactivated) Vaccine

Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac

Sponsors & Collaborators

  • Butantan Institute

    lead OTHER_GOV

Principal Investigators

  • Fernanda Boulos, MD, MSc · Butantan Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-07
Primary Completion
2023-03-07
Completion
2023-07-20

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04747821 on ClinicalTrials.gov