Clinical trial NCT05873751: A Study to Learn About How Trumenba Vaccine Shots Work Against Gonorrhea Infection in Teenagers and Young Adults in the United States.
Official title: Effect of Trumenba on Gonococcal Infections in Adolescents and Young Adults in the United States: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gonorrhea
Chlamydia
Meningococcal Vaccines
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-05-24
Enrollment: 1307378
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Gonococcal Infection After at Least 1 Dose of Trumenba to Determine Vaccine Effectiveness (VE)
timeFrame: 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:
measure: Number of Participants With Gonococcal Infection After at Least 2 Doses of Trumenba to Determine VE
timeFrame: 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)
measure: Number of Participants With Chlamydial Infection After at Least 1 Dose of Trumenba to Determine VE
timeFrame: 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)
measure: Number of Participants With Chlamydial Infection After at Least 2 Doses of Trumenba to Determine VE
timeFrame: 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)
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: