Comparison · NCT01545375-295cd0d0
dPly-PhtD Group vs Control Group: Number of Subjects With Any Serious Adverse Events (SAEs)
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. dPly-PhtD Group vs Control Group: Number of Subjects With Any Serious Adverse Events (SAEs). Trial comparisons, record NCT01545375-295cd0d0. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01545375-295cd0d0
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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 | 0.254 | 0.227 | 0.284 | wilson | |
| Risk in group 2 | 0.257 | 0.229 | 0.286 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00248 | -0.0427 | 0.0378 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.99 | 0.846 | 1.16 | log | |
| Odds ratio, group 1 over group 2 | 0.987 | 0.799 | 1.22 | log | |
| Number needed to treat, for one fewer participant with the outcome on dPly-PhtD Group than on Control Group | 404 | 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 | dPly-PhtD Group | Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate. | 229 | 900 | OG000 |
| Group 2 | Control Group | Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate. | 232 | 903 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Subjects With Any Serious Adverse Events (SAEs)
- Description
An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.
- Time frame
- From Day 0 to Month 22
- Population
- Analysis was performed on the Total vaccinated cohort which included all subjects who had received at least one vaccination dose.
Source ClinicalTrials.gov
Trial
- Title
- Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children
- NCT number
- NCT01545375
- Phases
- PHASE2
- Conditions
- Infections, Streptococcal
- Interventions
- Pneumococcal vaccine GSK2189242A, Placebo, Prevnar 13®, PedvaxHIB®
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2017-09-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01545375?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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