# Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older

> **NCT00976027** · PHASE3 · TERMINATED · sponsor: **Sanofi** · enrollment: 9172 (actual)

## Conditions studied

- Influenza

## Interventions

- **BIOLOGICAL:** Trivalent inactivated influenza vaccine High Dose
- **BIOLOGICAL:** Trivalent inactivated influenza vaccine

## Key facts

- **NCT ID:** NCT00976027
- **Lead sponsor:** Sanofi
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2009-09
- **Primary completion:** 2011-05
- **Final completion:** 2012-04
- **Target enrollment:** 9172 (ACTUAL)
- **Why stopped:** No safety concerns, study terminated due to lack of primary endpoint cases in 2009-2010 Flu season (coincided with H1N1 Pandemic) Subjects followed per-protocol
- **Last updated:** 2012-08-01


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00976027

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00976027, "Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older". Retrieved via AI Analytics 2026-06-09 from https://api.ai-analytics.org/clinical/NCT00976027. Licensed CC0.

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