Comparison · NCT01480258-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 NCT01480258-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01480258-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 | 0.00919 | 0.00422 | 0.0199 | wilson | |
| Risk in group 2 | 0.0152 | 0.00826 | 0.0277 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00599 | -0.0195 | 0.00676 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.606 | 0.221 | 1.66 | log | |
| Odds ratio, group 1 over group 2 | 0.602 | 0.217 | 1.67 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on PR5I than on INFANRIX™ Hexa | 167 | 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 | Infant series: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \[subset 1\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \[subset 2\]). Toddler dose: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age. | 6 | 653 | EG000 |
| Group 2 | INFANRIX™ Hexa | Infant series: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \[subset 1\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \[subset 2\]). Toddler dose: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age. | 10 | 659 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Up to approximately 11 months (serious AEs and deaths were collected for the duration of the study; unsolicited adverse events were collected from D1 to D15 after each hexavalent vaccination, solicited adverse events were collected D1 to D5 after each hexavalent vaccination)
Source ClinicalTrials.gov
Trial
- Title
- Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)
- NCT number
- NCT01480258
- Phases
- PHASE3
- Conditions
- Bacterial Infections, Virus Diseases
- Interventions
- PR5I, Rotavirus vaccine, Prevenar 13™, INFANRIX™ hexa
- Lead sponsor
- MCM Vaccines B.V.
- Results first posted
- 2019-04-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01480258?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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