Clostridium Difficile Vaccine vs Placebo: Number of Participants Reporting Serious Adverse Events (SAEs)
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 | 0.0824 | 0.0768 | 0.0884 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0828 | 0.0772 | 0.0888 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.000382 | -0.00856 | 0.0078 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.995 | 0.902 | 1.1 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.995 | 0.893 | 1.11 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Clostridium Difficile Vaccine than on Placebo | 2,620 | 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. | 719 | 8,722 | 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. | 722 | 8,718 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Number of Participants Reporting Serious Adverse Events (SAEs) | ClinicalTrials.gov |
| Description | An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event. | ClinicalTrials.gov |
| Time frame | From Day 1 of Dose 1 up to 6 months after Dose 3 (up to Month 12) | ClinicalTrials.gov |
| Population | Safety analysis population included all participants who received at least 1 dose of the investigational product. | 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.