Comparison · NCT01346293-sae
DTaP-IPV vs DAPTACEL®+IPOL®: 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. DTaP-IPV vs DAPTACEL®+IPOL®: serious adverse events. Trial comparisons, record NCT01346293-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01346293-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 | 0.00768 | 0.00503 | 0.0117 | wilson | |
| Risk in group 2 | 0.00483 | 0.00164 | 0.0141 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00285 | -0.00679 | 0.00799 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.59 | 0.476 | 5.32 | log | |
| Odds ratio, group 1 over group 2 | 1.6 | 0.474 | 5.36 | log | |
| Number needed to harm, for one more participant with a serious adverse event on DTaP-IPV than on DAPTACEL®+IPOL® | 351 | 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 | DTaP-IPV | Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly | 21 | 2,733 | EG000 |
| Group 2 | DAPTACEL®+IPOL® | Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL® | 3 | 621 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
Source ClinicalTrials.gov
Trial
- Title
- Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age
- NCT number
- NCT01346293
- Phases
- PHASE3
- Conditions
- Tetanus, Diphtheria, Pertussis, Measles, Polio
- Interventions
Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus, Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus, Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus, Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Results first posted
- 2015-05-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01346293?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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