MedTrace Logo

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

NCT04651790 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2300

Last updated 2023-02-02

No results posted yet for this study

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.

Conditions

  • Covid19
  • Vaccines

Interventions

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.

Sponsors & Collaborators

  • Ministry of Health, Chile

    collaborator OTHER_GOV

  • Sinovac Biotech Co., Ltd

    collaborator INDUSTRY

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • Katia Abarca, MD · Pontificia Universidad Catolica de Chile

  • Alexis M Kalergis, PhD · Pontificia Universidad Catolica de Chile

  • Susan M Bueno, PhD · Pontificia Universidad Catolica de Chile

  • Pablo A González, PhD · Pontificia Universidad Catolica de Chile

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-27
Primary Completion
2022-08-01
Completion
2022-11-01

Countries

  • Chile

Study Locations

More Related Trials

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 NCT04651790 on ClinicalTrials.gov