PCV13-vaccinated Participants vs Unvaccinated Participants: PCV13 Vaccine Effectiveness (VE) for First Event of Invasive Pneumococcal Disease (IPD): Overall Follow-up
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.00195 | 0.00168 | 0.00227 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00233 | 0.00217 | 0.0025 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.000376 | -0.0007 | -0.000019 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.838 | 0.709 | 0.991 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.838 | 0.709 | 0.991 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on PCV13-vaccinated Participants than on Unvaccinated Participants | 2,660 | 1,430 | 52,700 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
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 | Source |
|---|---|---|---|---|---|---|
| Group 1 | PCV13-vaccinated Participants | Participants with an HIV diagnosis code who received PCV13 were included. The participants were followed up in the databases from 14 days after their PCV13 or index date if vaccinated during the baseline period, until the earliest occurrence of outcome, death, end of health plan enrollment, or end of study period. | 167 | 85,584 | OG000 | ClinicalTrials.gov |
| Group 2 | Unvaccinated Participants | Participants with an HIV diagnosis code who did not receive PCV13 were included. The participants were followed in the databases from index date until the earliest occurrence of PCV13 vaccination, death, end of health plan enrollment or end of study period. | 747 | 320,959 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | PCV13 Vaccine Effectiveness (VE) for First Event of Invasive Pneumococcal Disease (IPD): Overall Follow-up | ClinicalTrials.gov |
| Description | VE:\[(1-hazard ratio (HR)\]\*100 and was obtained from marginal structural Cox models(Cox-MSM) after applying Inverse probability of treatment (IPT)\*Inverse probability of censoring(IPC)weights.IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. IPD: based on International Classification of Diseases,9th revision, Clinical Modification(ICD-9-CM)or ICD-10-CM.Data for total number of participants with IPD is reported in descriptive and VE (IPTW\*IPCW+imbalanced variables) is reported in statistical section.PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up). | ClinicalTrials.gov |
| Time frame | From index date to the earliest of death, end of health plan enrollment or end of study period (maximum up to 8.25 years) | ClinicalTrials.gov |
| Population | PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'Overall Number of Participants Analyzed (N)' for Unvaccinated arm=participants unvaccinated at start of study evaluable for this outcome measure (OM); N for vaccinated arm=participants vaccinated by end of follow up for this OM; hence, N is different from those reported under participant flow and baseline. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | A Study To Learn About The Effects Of Pneumococcal Vaccine In People With HIV | ClinicalTrials.gov |
| NCT number | NCT05794191 | ClinicalTrials.gov |
| Phases | ClinicalTrials.gov | |
| Conditions | HIV, Pneumonia, Infections, Pneumococcal | ClinicalTrials.gov |
| Interventions | Vaccine Administration | ClinicalTrials.gov |
| Lead sponsor | Pfizer | ClinicalTrials.gov |
| Results first posted | 2025-10-20 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT05794191?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.