deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT01887912

Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection

Efficacy, Immunogenicity, and Safety Study of Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection (Cdiffense™)

Sponsor: Sanofi Pasteur, a Sanofi Company

Updated 18 times since 2017 Last updated: Mar 21, 2022 Started: Jul 30, 2013 Primary completion: Jun 12, 2018 Completion: Jun 12, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The Independent Data Monitoring Committee (IDMC) concluded that the probability that the study will meet its primary objective is low.

This PHASE3 trial investigates Clostridium Difficile Infection and is currently terminated or withdrawn. Sanofi Pasteur, a Sanofi Company leads this study, which shows 18 recorded versions since 2013 — indicating substantial longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jul 2017 · 5 months · monthly snapshot~Jul 2017 – ~Aug 2017 · 31 days · monthly snapshot~Aug 2017 – ~Oct 2017 · 2 months · monthly snapshot~Oct 2017 – ~Dec 2017 · 2 months · monthly snapshot~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~Aug 2019 · 12 months · monthly snapshot~Aug 2019 – ~Nov 2020 · 15 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshot~Dec 2021 – ~Apr 2022 · 4 months · monthly snapshot~Apr 2022 – ~Jul 2024 · 27 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshot~Dec 2025 – ~Feb 2026 · 2 months · monthly snapshot~Feb 2026 – present · 5 months · monthly snapshot

Change History

18 versions recorded
  1. Feb 2026 — Present [monthly]

    Terminated PHASE3

  2. Dec 2025 — Feb 2026 [monthly]

    Terminated PHASE3

  3. Sep 2025 — Dec 2025 [monthly]

    Terminated PHASE3

  4. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE3

  5. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

Show 13 earlier versions
  1. Apr 2022 — Jul 2024 [monthly]

    Terminated PHASE3

  2. Dec 2021 — Apr 2022 [monthly]

    Terminated PHASE3

  3. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE3

  4. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE3

  5. Aug 2019 — Nov 2020 [monthly]

    Terminated PHASE3

  6. Aug 2018 — Aug 2019 [monthly]

    Terminated PHASE3

    Status: Active Not RecruitingTerminated

  7. Jun 2018 — Aug 2018 [monthly]

    Active Not Recruiting PHASE3

  8. Dec 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  9. Oct 2017 — Dec 2017 [monthly]

    Recruiting PHASE3

  10. Aug 2017 — Oct 2017 [monthly]

    Recruiting PHASE3

  11. Jul 2017 — Aug 2017 [monthly]

    Recruiting PHASE3

    Status: Active Not RecruitingRecruiting

  12. Feb 2017 — Jul 2017 [monthly]

    Active Not Recruiting PHASE3

  13. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Jul 2013

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Sanofi Pasteur, a Sanofi Company
Data source: Sanofi

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