A Study to Learn About How Trumenba Vaccine Shots Work Against Gonorrhea Infection in Teenagers and Young Adults in the United States.
Study Details
Study Description
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:
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Are 15-30 years old.
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Have received at least one dose of Trumenba and a MenACWY vaccine or who have received only MenACWY vaccine.
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)]
- 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)]
- 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)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Individuals of 15-30 years old registered in the PharMetrics Plus system
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Individuals having the index vaccination event at the age of 15-30 in 2016-2021
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Individual with continuous enrollment for 60 months during 2016-2020 to capture complete medical claims history
Exclusion Criteria:
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Individuals having any dose of Bexsero at any time during the study period and prior to the study
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Individuals with incomplete information on variables to be collected.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer | New York | New York | United States | 10001 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- B1971066