Comparison · NCT01536405-sae
MMRV (AMP) vs MMRV (2006 Process): 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. MMRV (AMP) vs MMRV (2006 Process): serious adverse events. Trial comparisons, record NCT01536405-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01536405-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 | 0.0308 | 0.0202 | 0.0466 | wilson | |
| Risk in group 2 | 0.0264 | 0.0167 | 0.0413 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00444 | -0.0138 | 0.023 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.17 | 0.628 | 2.17 | log | |
| Odds ratio, group 1 over group 2 | 1.17 | 0.62 | 2.22 | log | |
| Number needed to harm, for one more participant with a serious adverse event on MMRV (AMP) than on MMRV (2006 Process) | 225 | 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 | MMRV (AMP) | Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP) | 21 | 682 | EG000 |
| Group 2 | MMRV (2006 Process) | Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process | 18 | 683 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 6 months (180 days) after vaccination 2
Source ClinicalTrials.gov
Trial
- Title
- Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)
- NCT number
- NCT01536405
- Phases
- PHASE3
- Conditions
- Measles, Mumps, Rubella, Varicella
- Interventions
- MMRV (AMP), MMRV (2006 process)
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2014-07-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01536405?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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