Completed PHASE1 INTERVENTIONAL 4-arm NCT00214461

Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly Volunteers

A Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study of the Safety, Tolerability and Immunogenicity of a Clostridium Difficile Toxoid Vaccine, Alum Adsorbed, in Healthy Elderly Volunteers (> or =65 Years)

Sponsor: Sanofi

Conditions Clostridium Infections

Interventions C. difficile toxoid vaccine (10 µg) C. difficile toxoid vaccine (2 µg) C. difficile toxoid vaccine (50 µg) Vaccine diluent buffer (Placebo)

Updated 6 times since 2017 Last updated: Apr 9, 2012 Started: Nov 30, 2005 Primary completion: Feb 28, 2006 Completion: Feb 28, 2006

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

This PHASE1 trial investigates Clostridium Infections and is currently completed. Sanofi leads this study, which shows 6 recorded versions since 2005 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Feb 2017 — Jun 2018 [monthly]

Completed PHASE1

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Completed PHASE1

First recorded

Nov 2005

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

• Lexington, United States
• Orlando, United States