NCT05812014

Clinical Trail of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021) in Participants Aged 18 Years and Older

A Multi-center, Randomized, Blinded, Placebo-controlled, Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021) as Booster in Participants Aged 18 Years and Older Who Completed Primary/1 Booster Dose(s) of SARS-CoV-2 Vaccination

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9,800 (estimated)
• Sponsor: AIM Vaccine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a multi-center, randomized, blinded, placebo-controlled, phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of SARS-CoV-2 bivalent mRNA vaccine (LVRNA021) as booster in participants aged 18 years and older who completed primary/1 booster dose(s) of SARS-CoV-2 vaccination.

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 Bivalent mRNA vaccine (LVRNA021)	One dose was administered by intramuscular injection, 100μg，1.0ml/dose
DRUG	0.9% sodium chloride solution	One dose was administered by intramuscular injection, 1.0ml/dose

Timeline

• Start date: 2023-03-25
• Primary completion: 2024-03-01
• Completion: 2024-06-01
• First posted: 2023-04-13
• Last updated: 2023-04-19

Locations

1 site across 1 country: Pakistan