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Immunogenicity and Safety Study of One Booster Dose of Trivalent COVID-19 Vaccine (Vero Cell), Inactivated

NCT05433272 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1400

Last updated 2023-01-12

No results posted yet for this study

Summary

This is a randomized, double-blind, active-controlled phase Ⅲ clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of one booster dose of trivalent COVID-19 vaccine (vero cell), inactivated, prototype strain, delta strain and omicron strain in healthy people aged 3 years old and above and have completed two or three doses of CoronaVac® in Colombia.

Conditions

Interventions

BIOLOGICAL

Trivalent COVID-19 Vaccine (Vero Cell), Inactivated, Prototype Strain, Delta Strain and Omicron Strain

The Trivalent COVID-19 Vaccine (Vero Cell), Inactivated, Prototype Strain, Delta Strain and Omicron Strain was developed by Sinovac Life Science Ltd. The antigen content of trivalent COVID-19 vaccine is a total of 18μg/0.5 ml, including 1200 SU/6 µg/0.5 ml for Prototype strain, 1200 SDU/6 µg/0.5 ml for Delta strain, and 1200 SOU/6 µg/0.5 ml for Omicron strain. The routine of administration is Intramuscular injection into deltoid region.

BIOLOGICAL

COVID-19 Vaccine (Vero Cell), Inactivated

The COVID-19 Vaccine (Vero Cell),Inactivated was manufactured by Sinovac Life Science Ltd.The antigen content of the active-controlled vaccine (CoronaVac) is 600 SU/3 µg/0.5 ml.The routine of administration is Intramuscular injection into deltoid region.

Sponsors & Collaborators

  • Sinovac Life Sciences Co., Ltd.

    collaborator INDUSTRY

  • Sinovac Biotech (Colombia) S.A.S.

    lead INDUSTRY

Principal Investigators

  • Andrés Cadena, Doctor · Clinica de la Costa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-10
Primary Completion
2023-09-10
Completion
2023-09-10

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Diseases

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 NCT05433272 on ClinicalTrials.gov