Trial record 1 of 2 for:
mrna-1083
A Study of mRNA-1083 (SARS-Cov-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06097273 |
Recruitment Status :
Active, not recruiting
First Posted : October 24, 2023
Last Update Posted : December 20, 2023
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Sponsor:
ModernaTX, Inc.
Information provided by (Responsible Party):
ModernaTX, Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | October 18, 2023 | ||||
First Posted Date ICMJE | October 24, 2023 | ||||
Last Update Posted Date | December 20, 2023 | ||||
Actual Study Start Date ICMJE | October 19, 2023 | ||||
Estimated Primary Completion Date | May 21, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study of mRNA-1083 (SARS-Cov-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age | ||||
Official Title ICMJE | A Phase 3, Randomized, Observer-Blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1083 (SARS-Cov-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age | ||||
Brief Summary | The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1083 as compared with active control, co-administered licensed influenza and severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) vaccines, in 2 independent age-group sub-study cohorts, healthy adults 65 years and older (Cohort A) and healthy adults 50 to <65 years of age (Cohort B). | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
8075 | ||||
Original Estimated Enrollment ICMJE |
8000 | ||||
Estimated Study Completion Date ICMJE | May 21, 2024 | ||||
Estimated Primary Completion Date | May 21, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol-defined inclusion/exclusion criteria may apply. |
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | Canada | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT06097273 | ||||
Other Study ID Numbers ICMJE | mRNA-1083-P301 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | ModernaTX, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | ModernaTX, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | ModernaTX, Inc. | ||||
Verification Date | December 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |