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NCT00976027 · ClinicalTrials.gov registry record · Phase 3
Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 9,172
- Enrollment target
NCT00976027: Clinical Trial Phase 3 study, sponsored by Sanofi.
NCT00976027 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 9,172 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1090% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00976027, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 9,172 participants
- Enrollment target
Study Summary
The aim of this study is to determine the efficacy of Fluzone High Dose vaccine and that of Fluzone® vaccine in the elderly. Primary objective: To measure the efficacy of the vaccine, defined as the prevention of laboratory-confirmed influenza caused by viral types/subtypes that are antigenically similar to those contained in the respective annual vaccine formulations. Secondary objectives: * To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone® vaccine in elderly adults, with respect to laboratory-confirmed influenza illness caused by any type or subtype of influenza virus. * To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone® vaccine in elderly adults, in preventing culture-confirmed influenza illness caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations.
Primary Outcome
The presence (and specific identification) of influenza virus in the respiratory tract of vaccinated individuals with influenza like illness (ILI) was confirmed by tissue culture (for infectious virus) and molecular techniques (polymerase chain reaction based assays), with results reported for cases cause by any viral type or subtype.
Interventions
- BIOLOGICAL Trivalent inactivated influenza vaccine
- BIOLOGICAL Trivalent inactivated influenza vaccine High Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9,172 participants |
| Start Date | 2009-09 |
| Est. Completion | 2012-04 |
| Phase | Phase 3 |
Why NCT00976027 stopped before completion
NCT00976027 is an interventional study that assigns participants to a tested intervention. Its 9,172 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 (1090% higher).
The record links to 0 conditions, and to 2 interventions - of which Trivalent inactivated influenza vaccine is the first listed.
NCT00976027 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00976027 about?
NCT00976027 is a clinical study titled "Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older". The aim of this study is to determine the efficacy of Fluzone High Dose vaccine and that of Fluzone® vaccine in the elderly. Primary objective: To measure the efficacy of the vaccine, defined as the prevention of laboratory-confirmed influenza caused by viral types/subtypes that are antigenically ...
What is the current status of trial NCT00976027?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 9,172 participants. The study started on 2009-09. Estimated completion is 2012-04.
What interventions are being tested in trial NCT00976027?
The interventions under investigation include: Trivalent inactivated influenza vaccine (BIOLOGICAL), Trivalent inactivated influenza vaccine High Dose (BIOLOGICAL).
Who is sponsoring clinical trial NCT00976027?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00976027's enrollment target sits among peer trials
9,172 31st of 2000 higher than 1,970 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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