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

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

• Trumenba Vaccine (Biological): Trumenba vaccine given as standard of care
• MenACWY Vaccine (Biological): MenACWY Vaccine given as standard of care

Primary outcomes

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

Secondary outcomes

• 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 (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.
• 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 (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.
• 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)]: 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.

Sex: All, ages: 15 Years to 30 Years

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.

Participant flow

Outcome results

• Number of Participants With Gonococcal Infection After at Least 1 Dose of Trumenba to Determine Vaccine Effectiveness (VE) (Primary), Count of participants, Participants: Exposed Cohort: Vaccinated With Trumenba + MenACWY 316; Non-Exposed Cohort: Vaccinated With MenACWY Only 2327
• Number of Participants With Gonococcal Infection After at Least 2 Doses of Trumenba to Determine VE (Secondary), Count of participants, Participants: Exposed Cohort: Vaccinated With Trumenba + MenACWY 165; Non-Exposed Cohort: Vaccinated With MenACWY Only 2327
• Number of Participants With Chlamydial Infection After at Least 1 Dose of Trumenba to Determine VE (Secondary), Count of participants, Participants: Exposed Cohort: Vaccinated With Trumenba + MenACWY 1138; Non-Exposed Cohort: Vaccinated With MenACWY Only 7261
• Number of Participants With Chlamydial Infection After at Least 2 Doses of Trumenba to Determine VE (Secondary), Count of participants, Participants: Exposed Cohort: Vaccinated With Trumenba + MenACWY 584; Non-Exposed Cohort: Vaccinated With MenACWY Only 7261

Adverse events

Time frame: Data for adverse events and deaths were not assessed/evaluated during the study; hence timeframe is not applicable.

• Study Protocol (PDF, 2023-04-21)
• Statistical Analysis Plan (PDF, 2023-04-21)

• Pfizer CT.gov Call Center, Study director, Pfizer