Comparison · NCT03918629-deaths
2-Dose Clostridium Difficile Vaccine vs 3-Dose Clostridium Difficile Vaccine: deaths from any cause
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. 2-Dose Clostridium Difficile Vaccine vs 3-Dose Clostridium Difficile Vaccine: deaths from any cause. Trial comparisons, record NCT03918629-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03918629-deaths
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0151 | 0.00917 | 0.0247 | wilson | |
| Risk in group 2 | 0.00702 | 0.00341 | 0.0144 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00807 | -0.00141 | 0.0184 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.15 | 0.88 | 5.25 | log | |
| Odds ratio, group 1 over group 2 | 2.17 | 0.88 | 5.34 | log | |
| Number needed to harm, for one more death from any cause on 2-Dose Clostridium Difficile Vaccine than on 3-Dose Clostridium Difficile Vaccine | 124 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 2-Dose Clostridium Difficile Vaccine | Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0) and visit 4 (Month 6) and 1 dose of placebo (0.9% sodium chloride) at visit 2 (Month 1). Participants were followed up to 6 months after last dose of vaccination at Month 6. | 15 | 994 | EG000 |
| Group 2 | 3-Dose Clostridium Difficile Vaccine | Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6. | 7 | 997 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Source ClinicalTrials.gov
Trial
- Title
- Clostridium Difficile Vaccine 2-Dose Versus 3-Dose Study
- NCT number
- NCT03918629
- Phases
- PHASE3
- Conditions
- Clostridium Difficile Associated Disease
- Interventions
- Clostridium difficile, Placebo
- Lead sponsor
- Pfizer
- Results first posted
- 2024-01-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03918629?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- 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
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone 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.
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