NCT05873751

A Study to Learn About How Trumenba Vaccine Shots Work Against Gonorrhea Infection in Teenagers and Young Adults in the United States.

Effect of Trumenba on Gonococcal Infections in Adolescents and Young Adults in the United States: A Retrospective Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,307,378 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 15 Years – 30 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a retrospective cohort study including individuals registered and available in the PharMetrics Plus database from 01 Jan 2016 to 31 Dec 2022 In order to estimate the effect of Trumenba vaccination, the cumulative incidence rate over time of the defined disease of interest among Trumenba + MenACWY vaccines will be compared to that among MenACWY vaccinees. Stratified analysis will be made by age groups, gender and state of residence

Conditions

• Gonorrhea
• Chlamydia
• Meningococcal Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	Trumenba Vaccine	Trumenba vaccine given as standard of care
BIOLOGICAL	MenACWY Vaccine	MenACWY Vaccine given as standard of care

Timeline

• Start date: 2023-04-24
• Primary completion: 2024-03-31
• Completion: 2024-03-31
• First posted: 2023-05-24
• Last updated: 2025-04-17
• Results posted: 2025-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study