Clinical trial

Effect of Trumenba on Gonococcal Infections in Adolescents and Young Adults in the United States: A Retrospective Cohort Study

Name
B1971066
Description
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. * Have enough months of data in the database. This data has already been collected in the past and is being studied between April and June of 2023.
Trial arms
Trial start
2023-04-24
Estimated PCD
2024-03-31
Trial end
2024-03-31
Status
Recruiting
Treatment
Trumenba Vaccine
Trumenba vaccine given as standard of care
Arms:
Trumenba +MenACWY Vaccinated
MenACWY Vaccine
MenACWY Vaccine given as standard of care
Arms:
MenACWY Only Vaccinated, Trumenba +MenACWY Vaccinated
Size
999
Primary endpoint
Number of gonococcal Infections in US adolescents and young adults 15-30 after at least one dose of Trumenba
>14 days after index vaccination through end of data period (up to 2543 days)
Eligibility criteria
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 3. Individual with continuous enrollment for 60 months during 2016-2020 to capture complete medical claims history 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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 999, 'type': 'ESTIMATED'}}
Updated at
2024-02-26

1 organization

2 products

3 indications

Product
Trumenba
Indication
Gonorrhea
Indication
Chlamydia
Organization
Pfizer