Comparison · NCT00313911-sae
DTaP-IPV-Hep B-PRP~T vs 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. DTaP-IPV-Hep B-PRP~T vs Tritanrix-Hep B/Hib™ + OPV: serious adverse events. Trial comparisons, record NCT00313911-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00313911-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 | 0.0639 | 0.0524 | 0.0779 | wilson | |
| Risk in group 2 | 0.0648 | 0.0489 | 0.0853 | wilson | |
| Risk difference, group 1 minus group 2 | -0.000839 | -0.0244 | 0.0203 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.987 | 0.7 | 1.39 | log | |
| Odds ratio, group 1 over group 2 | 0.986 | 0.683 | 1.42 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on DTaP-IPV-Hep B-PRP~T than on Tritanrix-Hep B/Hib™ + OPV | 1,190 | 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-Hep B-PRP~T | Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. | 91 | 1,423 | EG000 |
| Group 2 | Tritanrix-Hep B/Hib™ + OPV | Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. | 46 | 710 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection.
Source ClinicalTrials.gov
Trial
- Title
- Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
- NCT number
- NCT00313911
- Phases
- PHASE3
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b, Hepatitis B
- Interventions
- DTaP-IPV-HB-PRP~T, Tritanrix-HepB/Hib
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Results first posted
- 2012-11-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00313911?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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