A Safety and Immune Response Study to Evaluate Varying Doses of an mRNA Vaccine Against Coronavirus Disease 2019 (COVID-19) in Healthy Adults
Public ClinicalTrials.gov record NCT05972993. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Exploratory, First Time in Human (FTIH), Observer-blind, Randomized, Controlled Study to Evaluate Safety, Reactogenicity and Immunogenicity of Various Doses of GlaxoSmithKline Biologicals SA's (GSK) Investigational Omicron Variant S Glycoprotein (mRNA-CR-04) Vaccine When Administered Intramuscularly in Healthy Adults 18 to 49 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the safety, reactogenicity and immune responses of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA-CR-04 vaccine construct when administered in healthy adults previously vaccinated with SARS-CoV-2 mRNA vaccines.
Study identification
- NCT ID
- NCT05972993
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 114 participants
Conditions and interventions
Conditions
Interventions
- mRNA-CR-04 vaccine 10μg Biological
- mRNA-CR-04 vaccine 30μg Biological
- mRNA-CR-04 vaccine 100μg Biological
- Placebo Drug
- mRNA-CR-04 vaccine 3μg Biological
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years to 49 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 6, 2023
- Primary completion
- May 8, 2024
- Completion
- Oct 13, 2024
- Last update posted
- May 27, 2025
2023 – 2024
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | San Diego | California | 92108 | — |
| GSK Investigational Site | Melbourne | Florida | 32934 | — |
| GSK Investigational Site | Peoria | Illinois | 61614 | — |
| GSK Investigational Site | Austin | Texas | 78705 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05972993, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 27, 2025 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05972993 live on ClinicalTrials.gov.