drugset / Trial / NCT05593042

Immunogenicity Evaluation of Omicron Variant-based Vaccine and a Trivalent Vaccine in Adults Against COVID-19 in Chile

NCT05593042

RandomizedParallel-groupQuadruple-blindPrevention

Summary

Phase 2 clinical trial in adults previously vaccinated against SARS-CoV-2 in Chile with an initial schedule of two doses of CoronaVac® plus two booster doses with different vaccines. Subjects will randomly receive a third booster dose with Omicron, trivalent, or CoronaVac® vaccine. The humoral immunogenicity against COVID-19 will be compared in subjects that received the Omicron or the Trivalent vaccines with subjects that received CoronaVac® to determine the superiority of the two candidate vaccines versus CoronaVac®. Subjects will be followed for 6 months after the booster dose administration.

Timeline

Start
2022-11-28
Primary completion
2023-10-26
Completion
2023-10-26

Drugs

EvaluationDrugModalityDoseRoute
Comparator CoronaVac Vaccine 0.5 ml
Subject Omicron Vaccine Vaccine 0.5 ml
Subject Trivalent Vaccine Vaccine 0.5 ml

Indications