Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCT05873751 | Registry Identifier | ClinicalTrials.gov |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trumenba +MenACWY Vaccinated | Exposure Cohort that received at least one dose of Trumenba and MenACWY vaccine |
| |
| MenACWY Only Vaccinated | Non-exposure (reference cohort) that received at least one dose of MenACWY vaccine and no Trumenba vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trumenba Vaccine | Biological | Trumenba vaccine given as standard of care |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Male and female adolescents and young adults 15-30 years old included in the PharMetrics claims database from 01Jan2016 through 31Dec2022 Individuals in this cohort who have received the index vaccination between 2016 and 2021.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | New York | New York | 10001 | United States |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All eligible participants whose data were included in this retrospective study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All eligible participants whose data were included in this retrospective study. | Posted | Count of Participants | Participants | 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) |
|
Data for adverse events and deaths were not assessed/evaluated during the study; hence timeframe is not applicable.
This study involved data that existed as structured data and in these data sources individual identifying information was not available. The minimum criteria for reporting an adverse event (AE) (i.e., identifiable patient, identifiable reporter, a suspect product, and event) could not be met. Hence, adverse events were not planned to be evaluated.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer Clinical Trials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 21, 2023 | Mar 31, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 21, 2023 | Mar 31, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006069 | Gonorrhea |
| D002690 | Chlamydia Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
| ID | Term |
|---|---|
| C000729870 | MenB-FHbp vaccine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| MenACWY Vaccine |
| Biological |
MenACWY Vaccine given as standard of care |
|
| 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. | 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. | 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) |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| 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. |
| OG001 | 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. |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 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) |
|
|
|
|
| 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. | All eligible participants whose data were included in this retrospective study. | Posted | Count of Participants | Participants | 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) |
|
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 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) |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D002694 | Chlamydiaceae Infections |
| Midwest |
|
| West |
|
| Unknown |
|