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NCT04969276 · ClinicalTrials.gov registry record · Phase 2
Study of a Quadrivalent High-Dose Influenza Vaccine and a Moderna COVID-19 Vaccine Administered Either Concomitantly or Singly in Participants 65 Years of Age and Older Previously Vaccinated With a 2-dose Schedule of Moderna COVID-19 Vaccine
A Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 306
- Enrollment target
NCT04969276: Completed Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT04969276 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 306 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (130% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04969276, a Phase 2 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 306 participants
- Enrollment target
Study Summary
The main purpose of this Phase II study was to assess the safety and immunogenicity of a dose of Fluzone High-Dose (HD) Quadrivalent vaccine and a third dose or booster dose of Moderna coronavirus disease 19 (COVID-19) vaccine administered concomitantly or singly in adults 65 years of age and older having received their second dose of the 2-dose schedule of Moderna COVID-19 vaccine at least 5 months before enrollment in the study.
Primary Outcome
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs that occurred during that time were recorded as
Interventions
- BIOLOGICAL Quadrivalent Inactivated Influenza High Dose
- BIOLOGICAL COVID-19 mRNA Vaccine (nucleoside modified)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 306 participants |
| Start Date | 2021-07-16 |
| Est. Completion | 2022-02-08 |
| Phase | Phase 2 |
What the finished NCT04969276 record still lists
NCT04969276 is an interventional study that assigns participants to a tested intervention. The registered 306 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (130% higher).
The record links to 0 conditions, and to 2 interventions - of which Quadrivalent Inactivated Influenza High Dose is the first listed.
NCT04969276 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04969276 about?
NCT04969276 is a clinical study titled "Study of a Quadrivalent High-Dose Influenza Vaccine and a Moderna COVID-19 Vaccine Administered Either Concomitantly or Singly in Participants 65 Years of Age and Older Previously Vaccinated With a 2-dose Schedule of Moderna COVID-19 Vaccine". The main purpose of this Phase II study was to assess the safety and immunogenicity of a dose of Fluzone High-Dose (HD) Quadrivalent vaccine and a third dose or booster dose of Moderna coronavirus disease 19 (COVID-19) vaccine administered concomitantly or singly in adults 65 years of age and older ...
What is the current status of trial NCT04969276?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 306 participants. The study started on 2021-07-16. Estimated completion is 2022-02-08.
What interventions are being tested in trial NCT04969276?
The interventions under investigation include: Quadrivalent Inactivated Influenza High Dose (BIOLOGICAL), COVID-19 mRNA Vaccine (nucleoside modified) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04969276?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04969276's enrollment target sits among peer trials
306 165th of 2000 higher than 1,835 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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