Comparison · NCT00329849-sae
MenACWY-CRM vs MenACWY-PS: 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. MenACWY-CRM vs MenACWY-PS: serious adverse events. Trial comparisons, record NCT00329849-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00329849-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 | 0.00947 | 0.00499 | 0.0179 | wilson | |
| Risk in group 2 | 0.00182 | 0.000321 | 0.0102 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00766 | -0.00187 | 0.0162 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 5.21 | 0.662 | 41 | log | |
| Odds ratio, group 1 over group 2 | 5.25 | 0.663 | 41.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on MenACWY-CRM than on MenACWY-PS | 131 | 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 | MenACWY-CRM | Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM) | 9 | 950 | EG000 |
| Group 2 | MenACWY-PS | Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS) | 1 | 550 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age
- NCT number
- NCT00329849
- Phases
- PHASE3
- Conditions
- Meningococcal Disease
- Interventions
- Meningococcal ACWY-CRM conjugate vaccine, Meningococcal ACWY-PS polysaccharide vaccine
- Lead sponsor
- Novartis Vaccines
- Results first posted
- 2013-11-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00329849?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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