N/A
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.
Gonorrhea · Chlamydia · Meningococcal Vaccines
Bottom Line
View on ClinicalTrials.gov: NCT05873751 ↗Enrolled (actual)
1,307,378
Serious AEs
—
Results posted
Apr 2025
Primary outcome: Primary: Number of Participants With Gonococcal Infection After at Least 1 Dose of Trumenba to Determine Vaccine Effectiveness (VE) — 316; 2327 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Trumenba Vaccine (Biological); MenACWY Vaccine (Biological)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2024
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 | — |
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.
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.