CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 692 enrolled
Drug / intervention
CV0701 mRNA COVID-19 Vaccine (Low dose) +5 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05960097
NCT05960097Phase 2Completed

A Phase 2 Randomized, Active-controlled, Observer-blind Study to Assess the Safety, Reactogenicity, and Immunogenicity of a Booster Dose of Investigational COVID-19 mRNA Vaccines in Healthy Adults Who Previously Received a Complete Primary Vaccination Series With or Without Booster Dose(s)

GlaxoSmithKline·interventional·Posted Jul 25, 2023·Updated Oct 23, 2025

In Brief

A Phase 2 clinical trial evaluating CV0701 mRNA COVID-19 Vaccine (Low dose), CV0701 mRNA COVID-19 Vaccine (Medium dose), and 4 other interventions for SARS-CoV-2 and COVID-19. Completed, enrolled 692 participants across 17 sites in 2 countries.

Detailed Summary

The purpose of Part A of this study is to assess the immune response and safety of a booster dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the investigational vaccines to control vaccine. The purpose of Part B of this study is to assess the immune response and safety of a booster dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the investigational vaccine under three different storage conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSARS-CoV-2, COVID-19
CountriesAustralia, United States
CollaboratorsCureVac

Timeline

Phase 2CompletedFinished
202420252026
First PostedJul 25, 2023
Enrollment StartAug 1, 2023
Primary CompletionAug 30, 2024
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 2.9 years ago

Interventions

CV0701 mRNA COVID-19 Vaccine (Low dose)biological

Study vaccine was administered as a single intramuscular injection.

CV0701 mRNA COVID-19 Vaccine (Medium dose)biological

Study vaccine was administered as a single intramuscular injection.

CV0701 mRNA COVID-19 Vaccine (High dose)biological

Study vaccine was administered as a single intramuscular injection.

CV0601 mRNA COVID-19 Vaccinebiological

Study vaccine was administered as a single intramuscular injection.

Control vaccinebiological

Study vaccine was administered as a single intramuscular injection.

CV0801 mRNA COVID-19 Vaccinebiological

Study vaccine was administered as a single intramuscular injection.