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NCT05333289 · ClinicalTrials.gov registry record · Phase 1
A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults
A Phase 1 study of Seasonal Influenza, sponsored by ModernaTX.
- Completed
- Registry status
- Phase 1
- Development phase
- 572
- Enrollment target
- 15
- Study locations
NCT05333289: Completed Phase 1 study of Seasonal Influenza, sponsored by ModernaTX.
NCT05333289 is a Phase 1 study of Seasonal Influenza that has completed, run by ModernaTX. The registered enrollment target is 572 participants, above the 260-participant average among 3 other Seasonal Influenza trials with a reported enrollment target (120% higher). The trial reports 15 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05333289, a Phase 1 study of Seasonal Influenza, has completed, sponsored by ModernaTX.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 572 participants
- Enrollment target
- 15
- Study locations
Study Summary
The primary objective of this study is to evaluate the safety, reactogenicity, and humoral immunogenicity of mRNA-1020, mRNA-1030, and mRNA-1010 vaccines against vaccine-matched influenza A and B strains.
Primary Outcome
Solicited ARs (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. Note, no
Conditions Studied
Interventions
- BIOLOGICAL mRNA-1030
- BIOLOGICAL mRNA-1020
- BIOLOGICAL mRNA-1010
- BIOLOGICAL Active Comparator
Study Locations (15)
Florida
- Alliance for MultiSpecialty Research - Coral Gables
- Health Awareness, Inc. - Jupiter
North Carolina
- Lucas Research - Morehead City
- Trial Management Associates, LLC - Wilmington
Utah
- Olympus Family Medicine - Salt Lake City
- South Ogden Family Medicine - South Ogden
Arizona
- Foothills Research Center - Phoenix
Georgia
- IACT Health - Columbus
Iowa
- Meridian Clinical Research - Sioux City
Kansas
- Heartland Research Associates, LLC - Wichita
Missouri
- Sundance Clinical Research, LLC - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 572 participants |
| Start Date | 2022-04-06 |
| Est. Completion | 2022-11-22 |
| Phase | Phase 1 |
What the finished NCT05333289 record still lists
NCT05333289 is an interventional study that assigns participants to a tested intervention. The registered 572 participants enrollment target is mid-sized for trials with a published cap, above the 260-participant average among 3 other Seasonal Influenza trials with a reported enrollment target (120% higher).
The record links to 1 condition, with Seasonal Influenza appearing as the primary indexed condition, and to 4 interventions - of which mRNA-1030 is the first listed.
NCT05333289 lists 15 locations in 12 states (Florida, North Carolina, Utah).
Frequently Asked Questions
What is clinical trial NCT05333289 about?
NCT05333289 is a clinical study titled "A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults". The primary objective of this study is to evaluate the safety, reactogenicity, and humoral immunogenicity of mRNA-1020, mRNA-1030, and mRNA-1010 vaccines against vaccine-matched influenza A and B strains.
What is the current status of trial NCT05333289?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 572 participants. The study started on 2022-04-06. Estimated completion is 2022-11-22.
What conditions does trial NCT05333289 study?
This clinical trial studies the following conditions: Seasonal Influenza.
What interventions are being tested in trial NCT05333289?
The interventions under investigation include: mRNA-1030 (BIOLOGICAL), mRNA-1020 (BIOLOGICAL), mRNA-1010 (BIOLOGICAL), Active Comparator (BIOLOGICAL).
Who is sponsoring clinical trial NCT05333289?
This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05333289 being conducted?
This trial has 15 study locations across Arizona, Florida, Georgia, Iowa, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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