Immunogenicity and Safety of an Inactivated COVID-19 Vaccine

NCT04953325 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2022-04-14

No results posted yet for this study

Summary

This study is a randomized, placebo-controlled and open design, phase 4 clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the CoronaVac in healthy population aged 18 years and older.

Conditions

Interventions

BIOLOGICAL

Inactivated COVID-19 Vaccine

600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection

BIOLOGICAL

23-valent pneumococcal polysaccharide vaccine

25μg each of the following serotypes/each dose (0.5ml): 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F

BIOLOGICAL

Inactivated Hepatitis A Vaccine

500SU inactivated Hepatitis A virus in 1 mL of aluminium hydroxide solution per injection.

Sponsors & Collaborators

  • Sinovac Research and Development Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Li Zhang, Master · Shandong Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-09
Primary Completion
2021-10-31
Completion
2022-01-31

Countries

  • China

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 NCT04953325 on ClinicalTrials.gov