NCT05144139

A Phase I/II Clinical Trial in Healthy People Aged 18 Years and Above

A Phase I/II Clinical Trial to Evaluate the Safety, Immunogenicity and Immune Persistence of COVID-19 mRNA Vaccine in Healthy People Aged 18 Years and Above.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: Stemirna Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This clinical trial is a phase I/II clinical trial to evaluate the safety, immunogenicity and immune persistence of COVID-19 mRNA vaccine in healthy people aged 18 years and above.

Detailed description

This is the clinical trial including an open-label, single-arm Phase I study and a subsequent randomized, blind, placebo-parallel controlled Phase II study to evaluate the safety, immunogenicity and immune persistence of COVID-19 mRNA vaccine in healthy people aged 18-60 years and ≥18 years respectively, whose locations or circumstances put them at appreciable risk of acquiring COVID-19 and/or SARS-CoV-2 infection.

Conditions

• COVID-19 Pandemic

Interventions

Type	Name	Description
BIOLOGICAL	COVID-19 mRNA vaccine	Intramuscular injection, COVID-19 mRNA vaccine/placebo, 21 days interval

Timeline

• Start date: 2021-12-03
• Primary completion: 2022-08-28
• Completion: 2022-11-11
• First posted: 2021-12-03
• Last updated: 2022-12-28

Locations

1 site across 1 country: Laos