Comparison · NCT03197376-sae
Pneumosil vs Synflorix: 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. Pneumosil vs Synflorix: serious adverse events. Trial comparisons, record NCT03197376-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03197376-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 | 0.0339 | 0.0259 | 0.0443 | wilson | |
| Risk in group 2 | 0.0348 | 0.0239 | 0.0505 | wilson | |
| Risk difference, group 1 minus group 2 | -0.000874 | -0.0185 | 0.0142 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.975 | 0.613 | 1.55 | log | |
| Odds ratio, group 1 over group 2 | 0.974 | 0.602 | 1.58 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Pneumosil than on Synflorix | 1,140 | 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 | Pneumosil | Three doses of Pneumosil in primary series cohort and three + 1 booster dose in booster cohort | 51 | 1,503 | EG000 |
| Group 2 | Synflorix | Three doses of Synflorix in primary series cohort and three + 1 booster dose in booster cohort | 26 | 747 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Source ClinicalTrials.gov
Trial
- Title
- Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) in Healthy Infants
- NCT number
- NCT03197376
- Phases
- PHASE3
- Conditions
- Pneumonia, Pneumococcal
- Interventions
- Pneumosil, Synflorix
- Lead sponsor
- PATH
- Results first posted
- 2019-09-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03197376?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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