NCT04470609

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

A Randomized, Double-blind, Placebo-controlled, Phase Ib/IIb Trial of an Inactivated SARS-CoV-2 Vaccine in Healthy People Aged ⩾60 Years

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 471 (actual)
• Sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

This phase Ib/IIb trial is designed to evaluate the safety and immunogenicity of different doses of the Inactivated SARS-CoV-2 Vaccine based upon the randomized, double-blind and placebo-controlled principle. A total of 471 subjects aged ⩾60 years will be enrolled in the study, of which 96 and 375 will be enrolled for phase Ib and phase Ⅱb,respectively. The enrolled subjects in phase Ib receive two doses of low-, medium-, or high-dose of experimental vaccines or placebo at an interval of 28 days, while the enrolled subjects in Phase Ⅱb receive two doses of medium, high-dose experimental vaccines or placebo at an interval of 28 days.

Conditions

• COVID-19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-07-10
• Primary completion: 2020-10-30
• Completion: 2021-10-27
• First posted: 2020-07-14
• Last updated: 2023-10-11

Locations

1 site across 1 country: China