MedTrace Logo

Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of the Inactivated SARS-CoV-2 Vaccine (COVID-19)

NCT04560881 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2022-01-12

No results posted yet for this study

Summary

This is a randomized, double blind, placebo parallel-controlled phase III clinical trial to evaluate the efficacy, immunogenicity and safety of the inactivated SARS-CoV-2 Vaccine (Vero cell) in Argentine healthy population aged between 18 and 85 years old.

Conditions

  • COVID-19 Virus Infection

Interventions

BIOLOGICAL

Inactivated SARS-CoV-2 vaccine (Vero cell)

Immunization schedule: 2-doses of investigational vaccine or placebo are inoculated to the deltoid muscle of the upper arm according to the immunization schedule of Day 0, 21.

BIOLOGICAL

Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccine

Immunization schedule: 2-doses of investigational vaccine or placebo are inoculated to the deltoid muscle of the upper arm according to the immunization schedule of Day 0, 21.

Sponsors & Collaborators

  • Beijing Institute of Biological Products Co Ltd.

    collaborator INDUSTRY

  • China National Biotec Group Company Limited

    collaborator INDUSTRY

  • Fundación Huésped

    collaborator OTHER

  • Laboratorio Elea Phoenix S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2021-12-13
Completion
2021-12-13

Countries

  • Argentina

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 NCT04560881 on ClinicalTrials.gov