Meningococcal Group B vaccine Bexsero for Gonorrhea Prevention
Recruiting
18 years - 50 years
All
Phase
2
50 participants needed
1 Location
Brief description of study
Detailed description of study
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
evaluable participants. 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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Healthy Volunteers,STD/STI,Gonorrhea,Vaccine
-
Age: 18 years - 50 years
-
Gender: All
Updated on
04 Aug 2024.
Study ID: IRB-300005422