Gonorrhea Clinical Trial
Official title:
Effect of Trumenba on Gonococcal Infections in Adolescents and Young Adults in the United States: A Retrospective Cohort Study
NCT number | NCT05873751 |
Other study ID # | B1971066 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 24, 2023 |
Est. completion date | March 31, 2024 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Pfizer | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
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) |
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