Comparison · NCT03579459-sae
Clostridium Difficile Vaccine (Pooled Lots) vs Placebo: serious adverse events
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. Clostridium Difficile Vaccine (Pooled Lots) vs Placebo: serious adverse events. Trial comparisons, record NCT03579459-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03579459-sae
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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 | 0.0417 | 0.0309 | 0.0561 | wilson | |
| Risk in group 2 | 0.0453 | 0.0277 | 0.0734 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00361 | -0.0337 | 0.0192 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.92 | 0.516 | 1.64 | log | |
| Odds ratio, group 1 over group 2 | 0.917 | 0.501 | 1.68 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Clostridium Difficile Vaccine (Pooled Lots) than on Placebo | 277 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Clostridium Difficile Vaccine (Pooled Lots) | Participants received Clostridium difficile vaccine (200 microgram total toxoid per dose) Lot 1, Lot 2 or Lot 3 intramuscularly at Months 0, 1 and 6. | 41 | 983 | EG000 |
| Group 2 | Placebo | Participants received placebo (0.9% sodium chloride injection, in a 0.5 mL dose) intramuscularly at Months 0, 1 and 6. | 15 | 331 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Local reactions and systemic events (systematic assessment): within 7 days after vaccination. SAEs and other AEs: From Day 1 to 1 month after last vaccination (Up to Month 7)
Source ClinicalTrials.gov
Trial
- Title
- Evaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age
- NCT number
- NCT03579459
- Phases
- PHASE3
- Conditions
- Clostridium Difficile Associated Disease
- Interventions
- Clostridium difficile vaccine, placebo
- Lead sponsor
- Pfizer
- Results first posted
- 2023-01-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03579459?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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