ProQuad® Arm: Dose 2 vs ProQuad® Arm: Dose 1: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.00658 | 0.00435 | 0.00995 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0118 | 0.00871 | 0.0161 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00527 | -0.0101 | -0.000667 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.556 | 0.331 | 0.933 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.553 | 0.328 | 0.932 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with a serious adverse event on ProQuad® Arm: Dose 2 than on ProQuad® Arm: Dose 1 | 190 | 99.4 | 1,500 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
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 | Source |
|---|---|---|---|---|---|---|
| Group 1 | ProQuad® Arm: Dose 2 | Healthy infants (12 to 22 months of age) received ProQuad® Dose 2 on Day 28 to Day 42. | 22 | 3,342 | EG000 | ClinicalTrials.gov |
| Group 2 | ProQuad® Arm: Dose 1 | Healthy infants (12 to 22 months of age) received ProQuad® Dose 1 on Day 1. | 40 | 3,376 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2) | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Safety Study of ProQuad® rHA in Infants (V221-037) | ClinicalTrials.gov |
| NCT number | NCT00560755 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Measles, Mumps, Rubella, Varicella | ClinicalTrials.gov |
| Interventions | ProQuad® | ClinicalTrials.gov |
| Lead sponsor | Merck Sharp & Dohme LLC | ClinicalTrials.gov |
| Results first posted | 2017-10-17 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00560755?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.