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NCT06097273 · ClinicalTrials.gov registry record · Phase 3
A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
A Phase 3 study, sponsored by ModernaTX.
- Completed
- Registry status
- Phase 3
- Development phase
- 8,061
- Enrollment target
NCT06097273: Completed Phase 3 study, sponsored by ModernaTX.
NCT06097273 is a Phase 3 study that has completed, run by ModernaTX. The registered enrollment target is 8,061 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (946% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06097273, a Phase 3 study, has completed, sponsored by ModernaTX.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 8,061 participants
- Enrollment target
Study 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).
Primary Outcome
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. The Per Protocol Immunogenicity Set (PPIS) included all randomized participants who received study intervention, complied with the timing of immunogenicity blood sample collections to have both Baseline and Day 29 assessments using a window of -7 to +14 days, had no major dosing error, had negative reverse transcription polymerase chain reaction (RT-PCR) test for influenza and sever
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Influenza Vaccine
- BIOLOGICAL COVID-19 Vaccine
- BIOLOGICAL mRNA-1083
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8,061 participants |
| Start Date | 2023-10-19 |
| Est. Completion | 2024-05-28 |
| Phase | Phase 3 |
What the finished NCT06097273 record still lists
NCT06097273 is an interventional study that assigns participants to a tested intervention. Its 8,061 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (946% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT06097273 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06097273 about?
NCT06097273 is a clinical study titled "A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age". 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 ad...
What is the current status of trial NCT06097273?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 8,061 participants. The study started on 2023-10-19. Estimated completion is 2024-05-28.
What interventions are being tested in trial NCT06097273?
The interventions under investigation include: Placebo (BIOLOGICAL), Influenza Vaccine (BIOLOGICAL), COVID-19 Vaccine (BIOLOGICAL), mRNA-1083 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06097273?
This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06097273's enrollment target sits among peer trials
8,061 32nd of 2000 higher than 1,969 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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