Trial Outcomes & Findings for A Study to Learn About How Trumenba Vaccine Shots Work Against Gonorrhea Infection in Teenagers and Young Adults in the United States. (NCT NCT05873751)
NCT ID: NCT05873751
Last Updated: 2025-04-17
Results Overview
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.
COMPLETED
1307378 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)
2025-04-17
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
214552
|
1092826
|
|
Overall Study
COMPLETED
|
214552
|
1092826
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Exposed Cohort: Vaccinated With Trumenba + MenACWY
n=214552 Participants
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.
|
Non-Exposed Cohort: Vaccinated With MenACWY Only
n=1092826 Participants
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.
|
Total
n=1307378 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.97 Years
STANDARD_DEVIATION 1.32 • n=214552 Participants
|
17.18 Years
STANDARD_DEVIATION 1.99 • n=1092826 Participants
|
17.15 Years
STANDARD_DEVIATION 1.9 • n=1307378 Participants
|
|
Sex: Female, Male
Female
|
109013 Participants
n=214552 Participants
|
553213 Participants
n=1092826 Participants
|
662226 Participants
n=1307378 Participants
|
|
Sex: Female, Male
Male
|
105539 Participants
n=214552 Participants
|
539613 Participants
n=1092826 Participants
|
645152 Participants
n=1307378 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States · Northeast
|
36193 Participants
n=214552 Participants
|
199905 Participants
n=1092826 Participants
|
236098 Participants
n=1307378 Participants
|
|
Region of Enrollment
United States · South
|
85947 Participants
n=214552 Participants
|
390076 Participants
n=1092826 Participants
|
476023 Participants
n=1307378 Participants
|
|
Region of Enrollment
United States · Midwest
|
68134 Participants
n=214552 Participants
|
334106 Participants
n=1092826 Participants
|
402240 Participants
n=1307378 Participants
|
|
Region of Enrollment
United States · West
|
23963 Participants
n=214552 Participants
|
161031 Participants
n=1092826 Participants
|
184994 Participants
n=1307378 Participants
|
|
Region of Enrollment
United States · Unknown
|
315 Participants
n=214552 Participants
|
7708 Participants
n=1092826 Participants
|
8023 Participants
n=1307378 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Exposed Cohort: Vaccinated With Trumenba + MenACWY
n=214552 Participants
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.
|
Non-Exposed Cohort: Vaccinated With MenACWY Only
n=1092826 Participants
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.
|
|---|---|---|
|
Number of Participants With Gonococcal Infection After at Least 1 Dose of Trumenba to Determine Vaccine Effectiveness (VE)
|
316 Participants
|
2327 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Exposed Cohort: Vaccinated With Trumenba + MenACWY
n=92661 Participants
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.
|
Non-Exposed Cohort: Vaccinated With MenACWY Only
n=1092826 Participants
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.
|
|---|---|---|
|
Number of Participants With Gonococcal Infection After at Least 2 Doses of Trumenba to Determine VE
|
165 Participants
|
2327 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Exposed Cohort: Vaccinated With Trumenba + MenACWY
n=214552 Participants
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.
|
Non-Exposed Cohort: Vaccinated With MenACWY Only
n=1092826 Participants
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.
|
|---|---|---|
|
Number of Participants With Chlamydial Infection After at Least 1 Dose of Trumenba to Determine VE
|
1138 Participants
|
7261 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Exposed Cohort: Vaccinated With Trumenba + MenACWY
n=92661 Participants
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.
|
Non-Exposed Cohort: Vaccinated With MenACWY Only
n=1092826 Participants
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.
|
|---|---|---|
|
Number of Participants With Chlamydial Infection After at Least 2 Doses of Trumenba to Determine VE
|
584 Participants
|
7261 Participants
|
Adverse Events
Exposed Cohort: Vaccinated With Trumenba + MenACWY
Non-Exposed Cohort: Vaccinated With MenACWY Only
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER