deltatrials
Terminated PHASE1 INTERVENTIONAL 3-arm NCT00772954

Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity

A Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study of the Safety, Tolerability and Immunogenicity of Two Doses of a Clostridium Difficile Toxoid Vaccine, Alum Adsorbed, in Healthy Adult Volunteers (18 - 55 Years)

Sponsor: Sanofi

Updated 7 times since 2017 Last updated: Apr 19, 2012 Started: Mar 31, 2006 Primary completion: Jun 30, 2006 Completion: Jun 30, 2006
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Issues with CTM stability.

A PHASE1 clinical study on Clostridium Difficile Diarrhea and Clostridium Difficile Infection, this trial is terminated or withdrawn. The trial is conducted by Sanofi and has accumulated 7 data snapshots since 2006. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotTerminated~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotTerminated~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 22 months · monthly snapshotTerminated

Change History

7 versions recorded
  1. Sep 2024 — Present [monthly]

    Terminated PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1

  3. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE1

  4. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE1

  5. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE1

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Terminated PHASE1

  2. Jan 2017 — Feb 2017 [monthly]

    Terminated PHASE1

    First recorded

Mar 2006

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

No location information available.