Terminated PHASE3 INTERVENTIONAL 2-arm NCT00976027

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

Multi-Year Efficacy Study of Fluzone High-Dose Trivalent Vaccine Compared With Fluzone® Vaccine In Adults ≥ 65 Years of Age

Sponsor: Sanofi

Conditions Influenza

Interventions Trivalent inactivated influenza vaccine Trivalent inactivated influenza vaccine High Dose

Updated 11 times since 2017 Last updated: Jul 24, 2012 Started: Sep 30, 2009 Primary completion: May 31, 2011 Completion: Apr 30, 2012

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

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

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A PHASE3 clinical study on Influenza, this trial is terminated or withdrawn. The trial is conducted by Sanofi and has accumulated 11 data snapshots since 2009. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

Change History

11 versions recorded

Sep 2025 — Present [monthly]

Terminated PHASE3
Sep 2024 — Sep 2025 [monthly]

Terminated PHASE3
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE3
Dec 2021 — Jul 2024 [monthly]

Terminated PHASE3
Jan 2021 — Dec 2021 [monthly]

Terminated PHASE3

▶ Show 6 earlier versions

Nov 2020 — Jan 2021 [monthly]

Terminated PHASE3
Jun 2018 — Nov 2020 [monthly]

Terminated PHASE3
May 2018 — Jun 2018 [monthly]

Terminated PHASE3
Aug 2017 — May 2018 [monthly]

Terminated PHASE3
Feb 2017 — Aug 2017 [monthly]

Terminated PHASE3
Jan 2017 — Feb 2017 [monthly]

Terminated PHASE3

First recorded

Sep 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Sanofi

Data source: Sanofi

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Akron, United States , Anderson, United States , Arkansas City, United States , Aurora, United States , Birmingham, United States , Bristol, United States , Brockton, United States , Cary, United States , Celebration, United States , Charlotte, United States and 81 more locations