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

Pfizer

Status: Completed

Conditions: Meningococcal Vaccines; Gonorrhea; Chlamydia

Treatments: Biological: MenACWY Vaccine; Biological: Trumenba Vaccine

Study type: Observational

Funder types: Industry

Identifiers

NCT05873751

NCT05873751 (Registry Identifier)

B1971066

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,307,378 patients

Sex: All

Ages: 15 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Individuals of 15-30 years old registered in the PharMetrics Plus system
2. Individuals having the index vaccination event at the age of 15-30 in 2016-2021

Exclusion criteria

1. Individuals having any dose of Bexsero at any time during the study period and prior to the study
2. Individuals with incomplete information on variables to be collected.

Trial design

1,307,378 participants in 2 patient groups

Trumenba +MenACWY Vaccinated

Description:

Exposure Cohort that received at least one dose of Trumenba and MenACWY vaccine

Treatment:

Biological: Trumenba Vaccine

Biological: MenACWY Vaccine

MenACWY Only Vaccinated

Description:

Non-exposure (reference cohort) that received at least one dose of MenACWY vaccine and no Trumenba vaccine.

Treatment:

Biological: MenACWY Vaccine