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

NCT ID: NCT05873751

Last Updated: 2025-04-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1307378 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-24

Study Completion Date

2024-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Gonorrhea Chlamydia Meningococcal Vaccines

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Trumenba +MenACWY Vaccinated

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

Trumenba Vaccine

Intervention Type BIOLOGICAL

Trumenba vaccine given as standard of care

MenACWY Vaccine

Intervention Type BIOLOGICAL

MenACWY Vaccine given as standard of care

MenACWY Only Vaccinated

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

MenACWY Vaccine

Intervention Type BIOLOGICAL

MenACWY Vaccine given as standard of care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Trumenba Vaccine

Trumenba vaccine given as standard of care

Intervention Type BIOLOGICAL

MenACWY Vaccine

MenACWY Vaccine given as standard of care

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://pmiform.com/clinical-trial-info-request?StudyID=B1971066

To obtain contact information for a study center near you, click here.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCT05873751

Identifier Type: REGISTRY

Identifier Source: secondary_id

B1971066

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Clinical Evaluation of the ID NOW™ CT/NG Test
NCT06395675 NOT_YET_RECRUITING NA
Aztreonam for Pharyngeal Gonorrhea
NCT03867734 COMPLETED PHASE2/PHASE3