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.
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 Type
OBSERVATIONAL
Enrollment
1,307,378
Trumenba vaccine given as standard of care
MenACWY Vaccine given as standard of care
Pfizer
New York, New York, United States
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.
Time frame: 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 Gonococcal Infection After at Least 2 Doses of Trumenba to Determine 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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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)
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