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

NCT05812014 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9800

Last updated 2023-04-19

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • LiveRNA Therapeutics Inc.

    collaborator UNKNOWN

  • Ningbo Rongan Biological Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • AIM Vaccine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Fan Zhang · AIM Vaccine Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-25
Primary Completion
2024-03-31
Completion
2024-06-30

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05812014 on ClinicalTrials.gov