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Safety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19 in People Aged ⩾60 Years

NCT04470609 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 471

Last updated 2023-10-11

No results posted yet for this study

Summary

This study is a randomized, double-blinded, and placebo-controlled phase Ib/IIb clinical trial of the Inactivated SARS-CoV-2 Vaccine to evaluate the safety and immunogenicity of the vaccine in healthy people aged ⩾60 Years.

Conditions

Interventions

BIOLOGICAL

Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule

Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28

BIOLOGICAL

Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule

Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28

BIOLOGICAL

High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule

Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28

BIOLOGICAL

Placebo on a 0- and 28-day schedule

Two doses of placebo at the vaccination schedule of day 0,28

Sponsors & Collaborators

  • West China Second University Hospital

    collaborator OTHER

  • Yunnan Center for Disease Control and Prevention

    collaborator OTHER

  • Institute of Medical Biology, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Qin Yu · West China Second University Hospital

  • Xiaoqiang Liu · Yunnan Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-10
Primary Completion
2020-10-30
Completion
2021-10-27

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 NCT04470609 on ClinicalTrials.gov