NCT05745545

Clinical Trial of COVID-19 Vaccine（SARS-CoV-2 Variant(Omicron BA.5) mRNA Vaccine） in Participants Aged 18 Years and Over

A Single-center, Randomized, Blinded, Placebo-controlled Clinical Trial to Evaluate the Protective Efficacy, Safety and Immunogenicity of One Dose of the SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine in People Aged 18 Years and Older Who Had Received Two or Three Doses of Inactivated COVID-19 Vaccine

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,200 (estimated)
• Sponsor: AIM Vaccine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, randomized, blinded, placebo-controlled clinical trial to evaluate the protective efficacy, safety and immunogenicity of one dose of the SARS-CoV-2 variant (Omicron BA.5) mRNA vaccine in people aged 18 years and older who had received two or three doses of inactivated COVID-19 vaccine.

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine	One dose was administered by intramuscular injection, 100μg，1.0ml/dose
DRUG	Saline solution	One dose was administered by intramuscular injection, 0.5ml/vial

Timeline

• Start date: 2023-01-04
• Primary completion: 2023-09-01
• Completion: 2023-11-01
• First posted: 2023-02-27
• Last updated: 2023-02-28

Locations

1 site across 1 country: China