Comparison · NCT00500266-sae
13vPnC: Visit 1 to Visit 2 vs 13vPnC: 6-month Follow-up: 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. 13vPnC: Visit 1 to Visit 2 vs 13vPnC: 6-month Follow-up: serious adverse events. Trial comparisons, record NCT00500266-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00500266-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 | 0.00953 | 0.00519 | 0.0175 | wilson | |
| Risk in group 2 | 0.0391 | 0.0289 | 0.0526 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0296 | -0.0437 | -0.0167 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.244 | 0.123 | 0.484 | log | |
| Odds ratio, group 1 over group 2 | 0.237 | 0.118 | 0.475 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on 13vPnC: Visit 1 to Visit 2 than on 13vPnC: 6-month Follow-up | 33.8 | 22.9 | 60 | from the risk difference interval |
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 | 13vPnC: Visit 1 to Visit 2 | Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. Local reactions and systemic events were collected from Day 1 through Day 14. AEs were recorded from Visit 1 to Visit 2 (29-43 days after Visit 1). SAEs were collected throughout the study. | 10 | 1,049 | EG000 |
| Group 2 | 13vPnC: 6-month Follow-up | Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. At visit 3, the 6-month follow-up (166-194 days after Visit 1) only newly diagnosed chronic medical conditions were collected as AEs. SAEs were collected throughout the study. | 41 | 1,049 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3.
Source ClinicalTrials.gov
Trial
- Title
- Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects
- NCT number
- NCT00500266
- Phases
- PHASE3
- Conditions
- Pneumococcal Infections
- Interventions
- 13-valent Pneumococcal Conjugate Vaccine (13vPnC)
- Lead sponsor
- Pfizer
- Results first posted
- 2011-09-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00500266?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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