Chlamydia, Gonorrhea, Meningococcal Vaccines
Conditions
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
Interventions
BIOLOGICALTrumenba Vaccine
Trumenba vaccine given as standard of care
BIOLOGICALMenACWY Vaccine
MenACWY Vaccine given as standard of care
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to 30 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Participants (15-30 years of age) who received at least one dose of Trumenba and at least one dose of MenACWY prior to their Trumenba vaccination, between 01 January 2016 and 31 December 2021, were identified and their data (01 January 2016 to 31 December 2022) was retrieved from IQVIA PharMetrics Plus database. Available retrospective data was evaluated per objectives of the study during approximately 11 months.
Participants by arm
| Arm | Count |
|---|---|
| Exposed Cohort: Vaccinated With Trumenba + MenACWY Participants who had received at least one dose of Trumenba and at least one dose of MenACWY vaccine (prior to the Trumenba vaccination) between 01 January 2016 to 31 December 2021, their data was included in this retrospective study. Vaccination was not administered under this study. | 214,552 |
| Non-Exposed Cohort: Vaccinated With MenACWY Only Participants who had received at least one dose of MenACWY (but no doses of Trumenba vaccine) between 01-January-2016 to 31-December-2021, their data was included in this retrospective study. It is a reference cohort for this study. Vaccination was not administered under this study. | 1,092,826 |
| Total | 1,307,378 |
Baseline characteristics
| Characteristic | Non-Exposed Cohort: Vaccinated With MenACWY Only | Total | Exposed Cohort: Vaccinated With Trumenba + MenACWY |
|---|---|---|---|
| Age, Continuous | 17.18 Years STANDARD_DEVIATION 1.99 | 17.15 Years STANDARD_DEVIATION 1.9 | 16.97 Years STANDARD_DEVIATION 1.32 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States Midwest | 334106 Participants | 402240 Participants | 68134 Participants |
| Region of Enrollment United States Northeast | 199905 Participants | 236098 Participants | 36193 Participants |
| Region of Enrollment United States South | 390076 Participants | 476023 Participants | 85947 Participants |
| Region of Enrollment United States Unknown | 7708 Participants | 8023 Participants | 315 Participants |
| Region of Enrollment United States West | 161031 Participants | 184994 Participants | 23963 Participants |
| Sex: Female, Male Female | 553213 Participants | 662226 Participants | 109013 Participants |
| Sex: Female, Male Male | 539613 Participants | 645152 Participants | 105539 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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)
Population: All eligible participants whose data were included in this retrospective study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exposed Cohort: Vaccinated With Trumenba + MenACWY | Number of Participants With Gonococcal Infection After at Least 1 Dose of Trumenba to Determine Vaccine Effectiveness (VE) | 316 Participants |
| Non-Exposed Cohort: Vaccinated With MenACWY Only | Number of Participants With Gonococcal Infection After at Least 1 Dose of Trumenba to Determine Vaccine Effectiveness (VE) | 2327 Participants |
95% CI: [-10.35, 15.59]
Secondary
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)
Population: All eligible participants whose data were included in this retrospective study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exposed Cohort: Vaccinated With Trumenba + MenACWY | Number of Participants With Chlamydial Infection After at Least 1 Dose of Trumenba to Determine VE | 1138 Participants |
| Non-Exposed Cohort: Vaccinated With MenACWY Only | Number of Participants With Chlamydial Infection After at Least 1 Dose of Trumenba to Determine VE | 7261 Participants |
95% CI: [-10.35, 15.59]
Secondary
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)
Population: All eligible participants whose data were included in this retrospective study. Overall Number of Participants Analyzed signifies participants who received at least two doses of Trumenba were included in this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exposed Cohort: Vaccinated With Trumenba + MenACWY | Number of Participants With Chlamydial Infection After at Least 2 Doses of Trumenba to Determine VE | 584 Participants |
| Non-Exposed Cohort: Vaccinated With MenACWY Only | Number of Participants With Chlamydial Infection After at Least 2 Doses of Trumenba to Determine VE | 7261 Participants |
95% CI: [-23.5, 13.85]
Secondary
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)
Population: All eligible participants whose data were included in this retrospective study. Overall Number of Participants Analyzed signifies participants who received at least two doses of Trumenba were included in this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exposed Cohort: Vaccinated With Trumenba + MenACWY | Number of Participants With Gonococcal Infection After at Least 2 Doses of Trumenba to Determine VE | 165 Participants |
| Non-Exposed Cohort: Vaccinated With MenACWY Only | Number of Participants With Gonococcal Infection After at Least 2 Doses of Trumenba to Determine VE | 2327 Participants |
95% CI: [-23.5, 13.85]