NCT05354063

A Study of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Older Adults.

A Phase I, Randomized, Observer-blinded, Placebo-controlled and Dose-escalation Clinical Trial to Evaluate the Safety and Preliminary Immunogenicity of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Adults Aged 60 Years and Over.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

This is a phase I, randomized, observer-blinded, placebo-controlled and dose-escalation clinical trial to evaluate the safety and preliminary immunogenicity of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese healthy adults aged 60 years and over.

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	20 μg dose of SYS6006	20 μg dose of SYS6006 vaccine IM on day 0 and day 21.
BIOLOGICAL	30 μg dose of SYS6006	30 μg dose of SYS6006 vaccine IM on day 0 and day 21.
DRUG	Placebo	Placebo IM on day 0 and day 21.

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-09-05
• Completion: 2023-10-01
• First posted: 2022-04-29
• Last updated: 2023-05-24

Locations

2 sites across 1 country: China