Comparison · NCT01341639-sae
PR5I vs INFANRIX Hexa: 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. PR5I vs INFANRIX Hexa: serious adverse events. Trial comparisons, record NCT01341639-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01341639-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 | 0.0377 | 0.0253 | 0.0559 | wilson | |
| Risk in group 2 | 0.0364 | 0.0241 | 0.0544 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00134 | -0.0206 | 0.0233 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.584 | 1.84 | log | |
| Odds ratio, group 1 over group 2 | 1.04 | 0.572 | 1.88 | log | |
| Number needed to harm, for one more participant with a serious adverse event on PR5I than on INFANRIX Hexa | 746 | 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 | PR5I | The PR5I group received V419, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by V419 and ProQuad™ at 12 months, and Prevenar 13™ and ProQuad™ at 13 months. | 23 | 610 | EG000 |
| Group 2 | INFANRIX Hexa | The INFANRIX™ hexa group received INFANRIX™ hexa, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by INFANRIX™ hexa and ProQuad™ at 12 months; and Prevenar 13™ and ProQuad™ at 13 months. | 22 | 605 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 2 months after Toddler Dose (up to approximately age 14 months)
Source ClinicalTrials.gov
Trial
- Title
- Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)
- NCT number
- NCT01341639
- Phases
- PHASE3
- Conditions
- Bacterial Infections, Virus Diseases
- Interventions
- V419, INFANRIX™ hexa, RotaTeq, Prevenar 13, ProQuad™
- Lead sponsor
- MCM Vaccines B.V.
- Results first posted
- 2019-04-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01341639?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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