N/A
Completed N=1,307,378
A Study to Learn About How Trumenba Vaccine Shots Work Against Gonorrhea Infection in Teenagers and Young Adults in the United States.
Source: ClinicalTrials.gov NCT05873751 ↗Enrolled (actual)
1,307,378
Serious AEs
—
Results posted
Apr 2025
Primary outcomePrimary: Number of Participants With Gonococcal Infection After at Least 1 Dose of Trumenba to Determine Vaccine Effectiveness (VE) — 316; 2327 Participants
Summary
Brief Summary:
The main purpose of the study is to learn about how well Trumenba vaccine shot works against gonorrhea infection.
This study looks at data records from a database in the United States.
This study includes patient's data from the database who:
* Are 15-30 years old.
* Have received at least one dose of Trumenba and a MenACWY vaccine or who have received only MenACWY vaccine.
This data has already been collected in the past and is being studied between April and June of 2023.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Gonococcal Infection After at Least 1 Dose of Trumenba to Determine Vaccine Effectiveness (VE) |
316; 2327 | — |
| SECONDARY Number of Participants With Gonococcal Infection After at Least 2 Doses of Trumenba to Determine VE |
165; 2327 | — |
| SECONDARY Number of Participants With Chlamydial Infection After at Least 1 Dose of Trumenba to Determine VE |
1138; 7261 | — |
| SECONDARY Number of Participants With Chlamydial Infection After at Least 2 Doses of Trumenba to Determine VE |
584; 7261 | — |
Eligibility Criteria
Inclusion Criteria
- Individuals of 15-30 years old registered in the PharMetrics Plus system
- Individuals having the index vaccination event at the age of 15-30 in 2016-2021
Exclusion Criteria
- Individuals having any dose of Bexsero at any time during the study period and prior to the study
- Individuals with incomplete information on variables to be collected.
Data sourced from ClinicalTrials.gov (NCT05873751). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.