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

NCT05873751 | Completed Results FDA Drug

• 2 other identifiers: B1971066NCT05873751
• Study Type: observational
• Target: 1,307,378
• Locations: 1 country
• Sites: 1

Brief 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. This data has already been collected in the past and is being studied between April and June of 2023.

Conditions

Gonorrhea; Chlamydia; Meningococcal Vaccines

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Gonococcal Infection After at Least 1 Dose of Trumenba to Determine Vaccine Effectiveness (VE)

  Number of participants (cases) with infection of interest were reported. If a participant had repeated infection only first occurrence was considered, hence one participant with infection was counted only once. VE was calculated as 1 minus the hazard ratio (HR) multiplied by 100. VE is reported as part of statistical data in this outcome measure. The index date (zero time) was the date of the last dose of Trumenba vaccination, after at least one dose of MenACWY for the exposed cohort and first date of MenACWY vaccination for the unexposed cohort.

  During follow-up of maximum of 83.5 months (from 14 days after the index date up to 31 December 2022; available retrospective data evaluated for approximately 11 months of this study)

Secondary Outcomes (3)

• Number of Participants With Gonococcal Infection After at Least 2 Doses of Trumenba to Determine VE

  During follow-up of maximum of 83.5 months (from 14 days after the index date up to 31 December 2022; available retrospective data evaluated for approximately 11 months of this study)

• Number of Participants With Chlamydial Infection After at Least 1 Dose of Trumenba to Determine VE

  During follow-up of maximum of 83.5 months (from 14 days after the index date up to 31 December 2022; available retrospective data evaluated for approximately 11 months of this study)

• Number of Participants With Chlamydial Infection After at Least 2 Doses of Trumenba to Determine VE

  During follow-up of maximum of 83.5 months (from 14 days after the index date up to 31 December 2022; available retrospective data evaluated for approximately 11 months of this study)

Study Arms (2)

Trumenba +MenACWY Vaccinated

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

Biological: Trumenba Vaccine; Biological: MenACWY Vaccine

MenACWY Only Vaccinated

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

Biological: MenACWY Vaccine

Interventions

Trumenba Vaccine BIOLOGICAL

Trumenba vaccine given as standard of care

Trumenba +MenACWY Vaccinated

MenACWY Vaccine BIOLOGICAL

MenACWY Vaccine given as standard of care

MenACWY Only Vaccinated; Trumenba +MenACWY Vaccinated

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

New York, New York, 10001, United States

Location

Related Links

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

MeSH Terms

Conditions

Gonorrhea; Chlamydia Infections

Interventions

MenB-FHbp vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Chlamydiaceae Infections

Results Point of Contact

• Title: Pfizer Clinical Trials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 24, 2023
• Study Start: April 24, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: April 17, 2025
• Results First Posted: April 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)