drugset / Trial / NCT05636319

A Study to Evaluate the Efficacy, Safety, and Immunogenicity of SARS-CoV-2 Variant (BA.4 /5) mRNA Vaccine

NCT05636319 ↗

Phase 2/3 Unknown 14168 enrolled Suzhou Abogen Biosciences Co., Ltd.
RandomizedParallel-groupTriple-blindPrevention

Summary

A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of SARS-CoV-2 Variant (BA.4 /5) mRNA Vaccine (ABO1020) in Healthy Subjects Aged 18 Years and Older Who Have Completed the Full Vaccination

Timeline

Start
2022-11-23
Primary completion
2023-04-30
Completion
2024-07-31

Outcome

Met primary endpoint

paper yielding a vaccine efficacy of 66.18% (95% confidence interval: 57.21-73.27, p < 0.0001). PMID 39025066 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject ABO1020 Messenger RNA (mRNA) 15 ug Intramuscular

Indications