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

February 22, 2024 updated by: Pfizer

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

999

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10001
        • Recruiting
        • Pfizer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Male and female adolescents and young adults 15-30 years old included in the PharMetrics claims database from 01Jan2016 through 31Dec2022 Individuals in this cohort who have received the index vaccination between 2016 and 2021 and who have 60 months of continuous enrollment in the payer database.

Description

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Trumenba +MenACWY Vaccinated
Exposure Cohort that received at least one dose of Trumenba and MenACWY vaccine
Biological: Trumenba Vaccine
Trumenba vaccine given as standard of care
Biological: MenACWY Vaccine
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.
Biological: MenACWY Vaccine
MenACWY Vaccine given as standard of care

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2023

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

May 15, 2023

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1971066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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