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NCT05827068 · ClinicalTrials.gov registry record · Phase 1
A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults
A Phase 1 study of Seasonal Influenza, sponsored by ModernaTX.
- Completed
- Registry status
- Phase 1
- Development phase
- 698
- Enrollment target
- 20
- Study locations
NCT05827068: Completed Phase 1 study of Seasonal Influenza, sponsored by ModernaTX.
NCT05827068 is a Phase 1 study of Seasonal Influenza that has completed, run by ModernaTX. The registered enrollment target is 698 participants, above the 218-participant average among 3 other Seasonal Influenza trials with a reported enrollment target (220% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05827068, a Phase 1 study of Seasonal Influenza, has completed, sponsored by ModernaTX.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 698 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to measure the safety and the immune response to 3 next-generation influenza vaccine candidates (mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1) compared with influenza vaccine candidate mRNA-1010 controls in healthy adult participants.
Primary Outcome
Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Hea
Conditions Studied
Interventions
- BIOLOGICAL mRNA-1010
- BIOLOGICAL mRNA-1011.1
- BIOLOGICAL mRNA-1011.2
- BIOLOGICAL mRNA-1012.1
- BIOLOGICAL mRNA-1010.2
Study Locations (20)
Florida
- CenExel RCA - Hollywood
- Suncoast Research Associates, LLC - Miami
- CenExel FCR - Tampa
Missouri
- DelRicht Research - Springfield
- Sundance Clinical Research, LLC - St Louis
- DelRicht Research - Town and Country
California
- Long Beach Research Institute - Lakewood
- Long Beach Clinical Trials - Long Beach
Colorado
- Tekton Research - Fort Collins
- Critical Care, Pulmonary and Sleep Associates / CCT Research - Lakewood
Maryland
- CenExel CBH - Gaithersburg
- DelRicht Research - Rockville
Oklahoma
- Tekton Research - Edmond
- Tekton Research - Moore
Georgia
- Georgia Clinic / CCT Research - Norcross
Nebraska
- Meridian Clinical Research, LLC - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 698 participants |
| Start Date | 2023-03-27 |
| Est. Completion | 2023-11-20 |
| Phase | Phase 1 |
What the finished NCT05827068 record still lists
NCT05827068 is an interventional study that assigns participants to a tested intervention. The registered 698 participants enrollment target is mid-sized for trials with a published cap, above the 218-participant average among 3 other Seasonal Influenza trials with a reported enrollment target (220% higher).
The record links to 1 condition, with Seasonal Influenza appearing as the primary indexed condition, and to 5 interventions - of which mRNA-1010 is the first listed.
NCT05827068 names 20 study sites across 12 states, led by Florida, Missouri, California.
Frequently Asked Questions
What is clinical trial NCT05827068 about?
NCT05827068 is a clinical study titled "A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults". The purpose of this study is to measure the safety and the immune response to 3 next-generation influenza vaccine candidates (mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1) compared with influenza vaccine candidate mRNA-1010 controls in healthy adult participants.
What is the current status of trial NCT05827068?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 698 participants. The study started on 2023-03-27. Estimated completion is 2023-11-20.
What conditions does trial NCT05827068 study?
This clinical trial studies the following conditions: Seasonal Influenza.
What interventions are being tested in trial NCT05827068?
The interventions under investigation include: mRNA-1010 (BIOLOGICAL), mRNA-1011.1 (BIOLOGICAL), mRNA-1011.2 (BIOLOGICAL), mRNA-1012.1 (BIOLOGICAL), mRNA-1010.2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05827068?
This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05827068 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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