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NCT01427309 · ClinicalTrials.gov registry record · Phase 4
A Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults
A Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 31,989
- Enrollment target
NCT01427309: Completed Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT01427309 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 31,989 participants, above the 515-participant average among 9,235 other Phase 4 trials with a reported enrollment target (6111% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01427309, a Phase 4 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 31,989 participants
- Enrollment target
Study Summary
The aim of this study is to determine the efficacy of Fluzone High-Dose compared to standard dose Fluzone for laboratory-confirmed or culture-confirmed influenza caused by influenza types/subtypes that are similar (for laboratory-confirmed) or antigenically similar (for culture-confirmed) to those contained in the respective annual vaccine formulations. Primary Objective: * To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to laboratory-confirmed influenza caused by any influenza viral types/subtypes, associated with the occurrence of a protocol-defined influenza-like-illnesses (ILI). Secondary Objectives: * To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to laboratory-confirmed influenza, caused by any influenza viral types/subtypes, associated with the occurrence of a protocol-defined ILI. * To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza, caused by any influenza viral types/subtypes, associated with the occurrence of a protocol-defined ILI. * To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations, associated with the occurrence of a modified Centers for Disease Control and Prevention (CDC)-defined ILI. * To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza caused by any influenza viral types/subtypes, associated with the occurrence of a modified CDC-defined ILI. * To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza caused by viral types/subtypes antigenically similar to those contained in the respective
Primary Outcome
Influenza positive cultures were confirmed using direct immunofluorescence techniques with influenza type-specific antibodies. 3 culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture). The initial molecular test (PCR) was the validated ProFlu+™ assay by Prodesse, Inc., Waukesha, WI, which had been approved by the Food and Drug Administration t
Interventions
- BIOLOGICAL Trivalent Inactivated Influenza Vaccine
- BIOLOGICAL High Dose Trivalent Inactivated Influenza Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31,989 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-11 |
| Phase | Phase 4 |
What the finished NCT01427309 record still lists
NCT01427309 is an interventional study that assigns participants to a tested intervention. Its 31,989 participants enrollment target places it among the larger protocols in the corpus, above the 515-participant average among 9,235 other Phase 4 trials with a reported enrollment target (6111% higher).
The record links to 0 conditions, and to 2 interventions - of which Trivalent Inactivated Influenza Vaccine is the first listed.
NCT01427309 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01427309 about?
NCT01427309 is a clinical study titled "A Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults". The aim of this study is to determine the efficacy of Fluzone High-Dose compared to standard dose Fluzone for laboratory-confirmed or culture-confirmed influenza caused by influenza types/subtypes that are similar (for laboratory-confirmed) or antigenically similar (for culture-confirmed) to those c...
What is the current status of trial NCT01427309?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 31,989 participants. The study started on 2011-09. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01427309?
The interventions under investigation include: Trivalent Inactivated Influenza Vaccine (BIOLOGICAL), High Dose Trivalent Inactivated Influenza Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01427309?
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 NCT01427309's enrollment target sits among peer trials
31,989 4th of 2000 higher than 1,997 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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