Effect of Trumenba on Gonococcal Infections in Adolescents and Young Adults in the United States: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 999
- 试验地点
- 1
- 主要终点
- Number of Participants With Gonococcal Infection After at Least 1 Dose of Trumenba to Determine Vaccine Effectiveness (VE)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals of 15-30 years old registered in the PharMetrics Plus system
- •Individuals having the index vaccination event at the age of 15-30 in 2016-2021
- •Individual with continuous enrollment for 60 months during 2016-2020 to capture complete medical claims history
排除标准
- •Individuals having any dose of Bexsero at any time during the study period and prior to the study
- •Individuals with incomplete information on variables to be collected.
研究组 & 干预措施
Trumenba +MenACWY Vaccinated
Exposure Cohort that received at least one dose of Trumenba and MenACWY vaccine
干预措施: Trumenba Vaccine (Biological)
Trumenba +MenACWY Vaccinated
Exposure Cohort that received at least one dose of Trumenba and MenACWY vaccine
干预措施: MenACWY Vaccine (Biological)
MenACWY Only Vaccinated
Non-exposure (reference cohort) that received at least one dose of MenACWY vaccine and no Trumenba vaccine.
干预措施: MenACWY Vaccine (Biological)
结局指标
主要结局
Number of Participants With Gonococcal Infection After at Least 1 Dose of Trumenba to Determine Vaccine Effectiveness (VE)
时间窗: 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.
次要结局
- 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 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 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))