Main study design Sample Clauses

Main study design. ‌ This study is a randomized comparative immunogenicity study in an enrolled cohort. During this study, participants will be randomly assigned to receive an approved quadrivalent cell culture- based influenza vaccine (ccIIV4) and mRNA COVID-19 vaccine (Moderna) either concomitantly or sequentially, 28 days apart. Participants (aged 6-11 years and 18-64 years) will be enrolled in the 2023-2024 influenza season. Only two of the sites (Washington University in St. Louis and University Hospitals Cleveland Medical Center) will enroll children aged 6-11 years. Individuals will be enrolled who have not received their 2023-2024 influenza vaccine and have not received any COVID-19 vaccine in the preceding 6 months (i.e. at least 6 months have passed since their last COVID-19 vaccination). Participants will be enrolled if one dose of 2023-2024 influenza vaccine and a single booster dose of mRNA COVID-19 vaccine are indicated for current vaccination according to ACIP recommendations. To qualify for the study, children aged 8 years and younger must only need to receive a single dose of ccIIV4 per ACIP recommendations for the 2023-2024 season. mRNA COVID-19 vaccines recommended by CDC and/or authorized or approved by the FDA at the time of enrollment may include updated SARS-CoV-2 viral components which may be included in this study if authorized or approved by the FDA and recommended by the CDC. Demographic and health data (including influenza and COVID-19 vaccination and infection history) will be collected upon enrollment and verified after enrollment via electronic medical record extraction. Enrolled participants will be randomized to one of the following interventions (2:1:1) using a permuted block method stratified by age group (aged 6-11 years and 18-64 years) and site: (i) concomitant administration of the mRNA COVID-19 vaccine (Moderna) and quadrivalent influenza vaccine (ccIIV4); (ii) sequential administration of the quadrivalent influenza vaccine (ccIIV4) at Visit 1 (day 0) and the mRNA COVID-19 vaccine (Moderna) at Visit 2 (day 28); (iii) sequential administration of the mRNA COVID-19 vaccine (Moderna) at Visit 1 (day 0) followed by the quadrivalent influenza vaccine (ccIIV4) at Visit 2 (day 28). Whole blood samples to isolate sera, PBMC and plasma (target to collect PBMC and plasma samples at every visit from a subset of 250 participants; 200 adults and 50 children) will be collected prior to vaccination administration at Visit 1 (day 0) and Visit 2 (day 2...

Main study design. This study was conducted within the context of a larger cross-sectional study of men and women presenting at an urban STD clinic in Baltimore, MD between July 2000 and May 2002. Patients were eligible to participate if they were between 15 and 39 years of age, English- speaking, mentally competent to consent to participation, and did not have a known HIV diagnosis. Study participants completed a detailed behavioral audio computer-assisted self- interview (ACASI) questionnaire on sexual behaviors, prior STD history and symptoms, partner characteristics, condom use, and individual demographic characteristics. Participants and interviewers were matched by gender. Interviews were conducted in a private exam room prior to the patient being seen by the clinician. During the clinical exam, participating patients were asked to provide up to 20 ml of urine for detection of Chlamydia trachomatis and Neisseria gonorrhoeae by ligase chain reaction (LCR). For this sub-study, female participants were asked to provide a self-collected vaginal swab for detection of male DNA in vaginal fluid. All patients were provided a $30 food coupon for their participation. Of 1,079 female patients approached to participate in the study, 195 refused to participate, 188 patients did not show up for their scheduled interview, and 80 were found to be ineligible after initial screening. Of the 616 participants who completed the behavioral ACASI questionnaire, 607 participants provided a urine specimen for gonococcal and chlamydial infection testing. Furthermore, 511 female participants who completed the main study also provided a vaginal swab for Yc fragment testing, of which 478 produced a valid test result. The population of interest for this analysis comprises the 478 participants who completed the ACASI questionnaire and provided a self-collected vaginal swab which produced a valid result.