drugset / Trial / NCT04747821

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

NCT04747821

Phase 4 Completed 27711 enrolled Butantan Institute
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject CoronaVac Vaccine

Indications