Comparison · NCT02853929-9980652c
dTpa Group vs Control Group: Number of Subjects With Unsolicited Adverse Events (AEs)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. dTpa Group vs Control Group: Number of Subjects With Unsolicited Adverse Events (AEs). Trial comparisons, record NCT02853929-9980652c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02853929-9980652c
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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 | 0.357 | 0.302 | 0.417 | wilson | |
| Risk in group 2 | 0.401 | 0.345 | 0.459 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0433 | -0.124 | 0.0384 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.892 | 0.718 | 1.11 | log | |
| Odds ratio, group 1 over group 2 | 0.832 | 0.587 | 1.18 | log | |
| Number needed to treat, for one fewer participant with the outcome on dTpa Group than on Control Group | 23.1 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | dTpa Group | This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery.~All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure | 94 | 263 | OG000 |
| Group 2 | Control Group | This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery.~All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure | 111 | 277 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Subjects With Unsolicited Adverse Events (AEs)
- Description
An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
- Time frame
- During the 31-day (Day 0-Day 30) follow-up period after booster vaccination
- Population
- The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available
Source ClinicalTrials.gov
Trial
- Title
- Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
- NCT number
- NCT02853929
- Phases
- PHASE4
- Conditions
- Diphtheria, Hepatitis B, Acellular Pertussis, Haemophilus Influenzae Type b, Tetanus, Poliomyelitis, Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
- Interventions
- Infanrix hexa
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2020-01-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02853929?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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