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

Gonorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05873751
• Other study ID #: B1971066
• Status: Recruiting
• Start date: April 24, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: February 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 999
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chlamydia
• Gonorrhea
• Meningococcal Vaccines

Intervention

Biological:
• Trumenba Vaccine
Trumenba vaccine given as standard of care
• MenACWY Vaccine
MenACWY Vaccine given as standard of care

Locations

Country	Name	City	State
United States	Pfizer	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)

External Links

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