Comparison · NCT00483574-sae
Group 1: Menactra and Routine Pediatric Vaccines vs Group 2: Routine Pediatric Vaccines: 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. Group 1: Menactra and Routine Pediatric Vaccines vs Group 2: Routine Pediatric Vaccines: serious adverse events. Trial comparisons, record NCT00483574-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00483574-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 | 0.0399 | 0.0296 | 0.0535 | wilson | |
| Risk in group 2 | 0.0156 | 0.00667 | 0.0359 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0243 | 0.00152 | 0.0406 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.56 | 1.02 | 6.42 | log | |
| Odds ratio, group 1 over group 2 | 2.63 | 1.03 | 6.69 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Group 1: Menactra and Routine Pediatric Vaccines than on Group 2: Routine Pediatric Vaccines | 41.1 | 24.7 | 660 | 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 | Group 1: Menactra and Routine Pediatric Vaccines | Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively) | 42 | 1,053 | EG000 |
| Group 2 | Group 2: Routine Pediatric Vaccines | Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively) | 5 | 321 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Source ClinicalTrials.gov
Trial
- Title
- Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers
- NCT number
- NCT00483574
- Phases
- PHASE3
- Conditions
- Meningococcal Meningitis, Measles, Mumps, Rubella, Varicella
- Interventions
Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate, Measles-mumps-rubella-varicella vaccine, Routine paediatric vaccine - Pneumococcal conjugate (PCV), Routine paediatric vaccine - Hepatitis A
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Results first posted
- 2011-07-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00483574?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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