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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Gonorrhea, Chlamydia, Meningococcal Vaccines

Intervention / Treatment
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* Biological: Trumenba Vaccine
* Biological: MenACWY Vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trumenba +MenACWY Vaccinated<br>Exposure Cohort that received at least one dose of Trumenba and MenACWY vaccine | Biological: Trumenba Vaccine<br>* Trumenba vaccine given as standard of care<br>Biological: MenACWY Vaccine<br>* MenACWY Vaccine given as standard of care<br>|
| MenACWY Only Vaccinated<br>Non-exposure (reference cohort) that received at least one dose of MenACWY vaccine and no Trumenba vaccine. | Biological: MenACWY Vaccine<br>* MenACWY Vaccine given as standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of gonococcal Infections in US adolescents and young adults 15-30 after at least one dose of Trumenba |  | >14 days after index vaccination through end of data period (up to 2543 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of gonococcal infections in US adolescents and young adults 15-30 after at least 2 doses of Trumenba |  | >14 days after index vaccination through data period (up to 2543 days) | 
| Number of chlamydial infections in US adolescents and young adults 15-30 after at least 1 dose of Trumenba |  | >14 days after index vaccination through data period (up to 2543 days) | 
| Number of chlamydial Infections in US adolescents and young adults 15-30 after at least 2 doses of Trumenba |  | >14 days after index vaccination through data period (up to 2543 days) |