Comparison · NCT00450437-55e645ed
Novartis MenACWY Vaccine vs Licensed Meningococcal Vaccine: Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years
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: Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years. Trial comparisons, record NCT00450437-55e645ed. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00450437-55e645ed
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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 | 0.0355 | 0.0291 | 0.0432 | wilson | |
| Risk in group 2 | 0.0274 | 0.0185 | 0.0405 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00806 | -0.00649 | 0.0199 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.29 | 0.832 | 2.01 | log | |
| Odds ratio, group 1 over group 2 | 1.3 | 0.828 | 2.06 | log | |
| Number needed to treat, for one more participant with the outcome on Novartis MenACWY Vaccine than on Licensed Meningococcal 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 | Novartis MenACWY Vaccine | One dose of the meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly. | 94 | 2,649 | OG000 |
| Group 2 | Licensed Meningococcal Vaccine | One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly. | 24 | 875 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years
- Description
Safety of Novartis Meningococcal ACWY and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of participants presenting at least one severe systemic reaction during the first 7 days (Days 1-7) following a single vaccination.~Note: severe adverse events: unable to perform normal daily activity
- Time frame
- 6 days after vaccination
- Population
- The analysis was performed on the safety set.
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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