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

Completed

Conditions: Gonorrhea
Chlamydia
Meningococcal Vaccines

Interventions: Biological: Trumenba Vaccine
Biological: MenACWY Vaccine

Registration Number: NCT05873751

Lead Sponsor: Pfizer

Brief 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.

* Have enough months of data in the database.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 999

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
Individual with continuous enrollment for 60 months during 2016-2020 to capture complete medical claims history

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trumenba +MenACWY Vaccinated	MenACWY Vaccine	Exposure Cohort that received at least one dose of Trumenba and MenACWY vaccine
Trumenba +MenACWY Vaccinated	Trumenba Vaccine	Exposure Cohort that received at least one dose of Trumenba and MenACWY vaccine
MenACWY Only Vaccinated	MenACWY Vaccine	Non-exposure (reference cohort) that received at least one dose of MenACWY vaccine and no Trumenba vaccine.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Gonococcal Infection After at Least 1 Dose of Trumenba to Determine Vaccine Effectiveness (VE)	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)	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Gonococcal Infection After at Least 2 Doses of Trumenba to Determine VE	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)	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.
Number of Participants With Chlamydial Infection After at Least 1 Dose of Trumenba to Determine VE	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)	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.
Number of Participants With Chlamydial Infection After at Least 2 Doses of Trumenba to Determine VE	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)	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.