Comparison · NCT03692871-sae
V114 vs Prevnar 13™: 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. V114 vs Prevnar 13™: serious adverse events. Trial comparisons, record NCT03692871-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03692871-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 | 0.0977 | 0.0854 | 0.112 | wilson | |
| Risk in group 2 | 0.104 | 0.0786 | 0.136 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00622 | -0.0408 | 0.0227 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.94 | 0.691 | 1.28 | log | |
| Odds ratio, group 1 over group 2 | 0.934 | 0.663 | 1.32 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on V114 than on Prevnar 13™ | 161 | 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 | V114 | Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4). | 192 | 1,965 | EG000 |
| Group 2 | Prevnar 13™ | Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4). | 45 | 433 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1)
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)
- NCT number
- NCT03692871
- Phases
- PHASE3
- Conditions
- Pneumococcal Infections
- Interventions
- V114, Prevnar 13™
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2022-05-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03692871?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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