Exposed Cohort: Vaccinated With Trumenba + MenACWY vs Non-Exposed Cohort: Vaccinated With MenACWY Only: Number of Participants With Gonococcal Infection After at Least 1 Dose of Trumenba to Determine Vaccine Effectiveness (VE)
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 | 0.00147 | 0.00132 | 0.00164 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00213 | 0.00204 | 0.00222 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.000657 | -0.000834 | -0.000465 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.692 | 0.615 | 0.778 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.691 | 0.615 | 0.777 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Exposed Cohort: Vaccinated With Trumenba + MenACWY than on Non-Exposed Cohort: Vaccinated With MenACWY Only | 1,520 | 1,200 | 2,150 | 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 | Exposed Cohort: Vaccinated With Trumenba + MenACWY | Participants who had received at least one dose of Trumenba and at least one dose of MenACWY vaccine (prior to the Trumenba vaccination) between 01 January 2016 to 31 December 2021, their data was included in this retrospective study. Vaccination was not administered under this study. | 316 | 214,552 | OG000 | ClinicalTrials.gov |
| Group 2 | Non-Exposed Cohort: Vaccinated With MenACWY Only | Participants who had received at least one dose of MenACWY (but no doses of Trumenba vaccine) between 01-January-2016 to 31-December-2021, their data was included in this retrospective study. It is a reference cohort for this study. Vaccination was not administered under this study. | 2,327 | 1,092,826 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Number of Participants With Gonococcal Infection After at Least 1 Dose of Trumenba to Determine Vaccine Effectiveness (VE) | ClinicalTrials.gov |
| Description | Number of participants (cases) with infection of interest were reported. If a participant had repeated infection only first occurrence was considered, hence one participant with infection was counted only once. VE was calculated as 1 minus the hazard ratio (HR) multiplied by 100. VE is reported as part of statistical data in this outcome measure. The index date (zero time) was the date of the last dose of Trumenba vaccination, after at least one dose of MenACWY for the exposed cohort and first date of MenACWY vaccination for the unexposed cohort. | ClinicalTrials.gov |
| Time frame | During follow-up of maximum of 83.5 months (from 14 days after the index date up to 31 December 2022; available retrospective data evaluated for approximately 11 months of this study) | ClinicalTrials.gov |
| Population | All eligible participants whose data were included in this retrospective study. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | A Study to Learn About How Trumenba Vaccine Shots Work Against Gonorrhea Infection in Teenagers and Young Adults in the United States. | ClinicalTrials.gov |
| NCT number | NCT05873751 | ClinicalTrials.gov |
| Phases | ClinicalTrials.gov | |
| Conditions | Gonorrhea, Chlamydia, Meningococcal Vaccines | ClinicalTrials.gov |
| Interventions | Trumenba Vaccine, MenACWY Vaccine | ClinicalTrials.gov |
| Lead sponsor | Pfizer | ClinicalTrials.gov |
| Results first posted | 2025-04-17 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT05873751?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.