NCT04651790

Efficacy, Safety, and Immunogenicity of Two Vaccination Schedules of an Inactivated Vaccine Against COVID-19 in Adults

Multicenter, Phase 3, Randomized Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of Two Vaccination Schedules of an Inactivated Vaccine Against SARS-CoV-2 Infection in Adults.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,300 (actual)
• Sponsor: Pontificia Universidad Catolica de Chile · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study will evaluate the efficacy, safety, and immunogenicity of two vaccination schedules of an inactivated vaccine against SARS-CoV-2 infection in adults. Two doses of the vaccine will be administered in a 0,14 and a 0,28-day schedule. Follow-up of safety and efficacy will be assessed for 12 months after the first dose. Immunogenicity will be studied in a subgroup of participants.

Detailed description

This study will evaluate the efficacy, safety, and immunogenicity of two vaccination schedules of an inactivated vaccine against SARS-CoV-2 infection in adults. This study will be performed in 8 centers. Two schedules will be compared: 0,14 and 0,28-day, at a 1:1 rate. 40% of participants will be 60 or more years-old. Follow-up of safety and efficacy will be assessed for 12 months after administering the first dose. The collection of the data will be through an electronic Case Report Form. Immunogenicity will be studied in a subgroup of participants. Initially, 2,300 volunteers will be recruited.

Conditions

• Covid19
• Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 inactivated vaccine	The vaccine contains inactivated SARS-CoV-2 virus, aluminum hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate and sodium chloride.The final product will be supplied in a pre-filled syringe containing 0.5 ml of solution for injection that corresponds to a dose of the vaccine.

Timeline

• Start date: 2020-11-27
• Primary completion: 2022-08-01
• Completion: 2022-11-01
• First posted: 2020-12-03
• Last updated: 2023-02-02

Locations

1 site across 1 country: Chile