Comparison · NCT00450437-sae
Novartis MenACWY Vaccine vs Licensed Meningococcal Vaccine: 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. Novartis MenACWY Vaccine vs Licensed Meningococcal Vaccine: serious adverse events. Trial comparisons, record NCT00450437-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00450437-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 | 0.00868 | 0.00579 | 0.013 | wilson | |
| Risk in group 2 | 0.00571 | 0.00244 | 0.0133 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00297 | -0.00516 | 0.00838 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.52 | 0.579 | 3.98 | log | |
| Odds ratio, group 1 over group 2 | 1.52 | 0.578 | 4.02 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Novartis MenACWY Vaccine than on Licensed Meningococcal Vaccine | 337 | 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 | Novartis MenACWY Vaccine | One dose of the Novartis meningococcal ACWY conjugate vaccine (three lots combined) was administered intramuscularly, 11 to 55 years of age. | 23 | 2,649 | EG000 |
| Group 2 | Licensed Meningococcal Vaccine | One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly, 11 to 55 years of age. | 5 | 875 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Serious adverse events were collected from study day 1 to 180.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults
- NCT number
- NCT00450437
- Phases
- PHASE3
- Conditions
- Meningococcal Infections, Meningococcal Meningitis
- Interventions
- MenACWY CRM, Meningococcal ACWY Conjugate vaccine
- Lead sponsor
- Novartis Vaccines
- Results first posted
- 2010-09-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00450437?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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