Comparison · NCT00348881-sae
Group 1: DTaP-Hep B-PRP~T + OPV vs Group 2: Tritanrix-Hep B/ Hib™ + OPV: 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. Group 1: DTaP-Hep B-PRP~T + OPV vs Group 2: Tritanrix-Hep B/ Hib™ + OPV: serious adverse events. Trial comparisons, record NCT00348881-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00348881-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 | 0.0218 | 0.0154 | 0.0307 | wilson | |
| Risk in group 2 | 0.0169 | 0.00972 | 0.0294 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00481 | -0.00918 | 0.0163 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.28 | 0.663 | 2.48 | log | |
| Odds ratio, group 1 over group 2 | 1.29 | 0.658 | 2.53 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Group 1: DTaP-Hep B-PRP~T + OPV than on Group 2: Tritanrix-Hep B/ Hib™ + OPV | 208 | 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 | Group 1: DTaP-Hep B-PRP~T + OPV | Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. | 31 | 1,425 | EG000 |
| Group 2 | Group 2: Tritanrix-Hep B/ Hib™ + OPV | Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age. | 12 | 708 | 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 238 post-vaccination.
Source ClinicalTrials.gov
Trial
- Title
- Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants
- NCT number
- NCT00348881
- Phases
- PHASE3
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B, Influenza
- Interventions
- DTaP-HB-PRP~T combined vaccine, Tritanrix-HepB/Hib™ vaccine, Oral poliomyelitis vaccine (OPV)
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Results first posted
- 2013-10-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00348881?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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