drugset / Trial / NCT05992935

Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405 to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 80 Years of Age

NCT05992935 ↗

Phase 1/2 Active not recruiting 1407 enrolled ModernaTX, Inc.
RandomizedParallel-groupTriple-blindPrevention

Summary

The purpose of the Part A Phase 1 of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 and mRNA-1405 in healthy adult participants 18 to 49 years of age and 60 to 80 years of age. The purpose of Part B Phase 2 and Part C Phase 2 is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 in healthy adult participants (18 to 80 years of age).

Timeline

Start
2023-08-25
Primary completion
2026-09-22
Completion
2026-09-22

Drugs

EvaluationDrugModalityDoseRoute
Subject mRNA-1403 Messenger RNA (mRNA) — Intramuscular
Subject mRNA-1405 Messenger RNA (mRNA) — —