EICHORCondition: Gonococcal Infection · Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
This is a Phase II, randomized, observer-blind, placebo-controlled, multi-site trial of the FDA licensed rMenB+OMV NZ vaccine, Bexsero. The targeted study population is men and women 18-50 years of age who are disproportionately vulnerable to N. gonorrhoeae infection. Approximately 2,200 participants are expected to be enrolled to achieve at least 202 primary endpoints in the Per Protocol Population. Data will be collected in an observer-blind manner. Study product recipients and study staff responsible for the evaluation of any study endpoint will be unaware of whether Bexsero or placebo were administered. The duration of the study for participants who are enrolled and randomized will be approximately 16 months. Study participation is expected to be completed in approximately 36 months. The primary objective of the study is to demonstrate efficacy of Bexsero in prevention of urogenital and/or anorectal gonococcal infection.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
| University of Alabama at Birmingham School of Medicine - Infectious Disease | Birmingham, Alabama, United States | — |
| UCLA Clinical AIDS Research and Education (CARE) Center | Los Angeles, California, United States | — |
| SFDPH Bridge HIV Center | San Francisco, California, United States | — |
| Emory University School of Medicine - The Ponce de Leon Center | Atlanta, Georgia, United States | — |
| Emory University Hospital Midtown - Emory Clinic Infectious Diseases | Atlanta, Georgia, United States | — |
| University of Illinois at Chicago College of Medicine - Division of Infectious Diseases | Chicago, Illinois, United States | — |
| LSU - CrescentCare Sexual Health Center | New Orleans, Louisiana, United States | — |
| Walter Reed National Military Medical Center | Bethesda, Maryland, United States | — |
| Harlem Prevention Center, Columbia University, Mailman School of Public Health | New York, New York, United States | — |
| University of Pennsylvania HIV/AIDS Prevention Research Division | Philadelphia, Pennsylvania, United States | — |
| Malawi Clinical Research Site, Lilongwe | Lilongwe, Central Region, Malawi | — |
| The Thai Red Cross AIDS Research Centre | Bangkok, Thailand | — |
+ 1 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04350138