Autopsy report · NCT00772954

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

“Issues with CTM stability.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 2 years 7 months after it had already started.
• Ran for about 3 months before it stopped.
• 36 participants enrolled.
• Results were posted on the registry 5 years 11 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 1

Sponsor

Sanofi

Sponsor type

Industry

Conditions

Clostridium Difficile Infection; Clostridium Difficile Diarrhea

Interventions

Vaccine diluent buffer; Clostridium difficile toxoid vaccine (50 μg); Clostridium difficile toxoid vaccine (100 μg)

Participants

36

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.