NCT05939648

A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021)

Randomized, Blinded, Positive and Placebo-controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021) Booster Vaccination in People 18 Years of Age and Older Who Have Received SARS-CoV-2 Vaccine.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: AIM Vaccine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This trial is a phase II clinical trial of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021). The trial was randomized, blinded, placebo controlled. To evaluate the safety and immunogenicity of the study vaccine in participants aged 18 years and older who have received SARS-CoV-2 Vaccine.

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 Bivalent mRNA Vaccine	100 μg /1.0 mL/dose, slightly milky white and clear liquid, intramuscular injection into the lateral deltoid muscle of the upper arm.
OTHER	Saline	100 μg /1.0 mL/dose, intramuscular injection into the lateral deltoid muscle of the upper arm.

Timeline

• Start date: 2023-10-09
• Primary completion: 2023-11-30
• Completion: 2024-12-30
• First posted: 2023-07-11
• Last updated: 2023-11-24

Locations

1 site across 1 country: China