Clostridium Difficile Vaccine vs Placebo: Number of Participants With Recurrent Episodes of CDI (Definition 2) After Dose 3
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.000649 | 0.000277 | 0.00152 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.000384 | 0.000131 | 0.00113 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.000264 | -0.000568 | 0.00117 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.69 | 0.404 | 7.06 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.69 | 0.403 | 7.07 | log | ClinicalTrials.gov | |
| Number needed to treat, for one more participant with the outcome on Clostridium Difficile Vaccine than on Placebo | 3,780 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Clostridium Difficile Vaccine | Participants who received Clostridium difficile vaccine 200 microgram total toxoid per dose intramuscularly at Months 0, 1 and 6. | 5 | 7,707 | OG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Participants who received placebo (normal saline solution of 0.9 percent \[%\] sodium chloride) intramuscularly at Months 0, 1 and 6. | 3 | 7,805 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With Recurrent Episodes of CDI (Definition 2) After Dose 3 | ClinicalTrials.gov |
| Description | CDI definition 2 for a recurrent episode (an episode of CDI that occurred 8 weeks or less after the onset of a previous CDI episode \[provided the symptoms of the previous episode had resolved\]), was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours; and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (by PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases. | ClinicalTrials.gov |
| Time frame | From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months) | ClinicalTrials.gov |
| Population | Per Protocol-3 analysis population included all randomized participants who received dose 1, dose 2, and dose 3 of the investigational product to which they were randomized and had no major protocol violations up to and including 14 days after dose 3. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Clostridium Difficile Vaccine Efficacy Trial | ClinicalTrials.gov |
| NCT number | NCT03090191 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Clostridium Difficile Infection | ClinicalTrials.gov |
| Interventions | Clostridium difficile vaccine, Placebo | ClinicalTrials.gov |
| Lead sponsor | Pfizer | ClinicalTrials.gov |
| Results first posted | 2023-02-13 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT03090191?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.