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Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal Infection

Study testing Meningococcal B vaccine for gonorrhea prevention effectiveness.

Recruiting
18-50 years
All
Phase 2

This study tests the safety and effectiveness of a vaccine called **Bexsero** to prevent **gonorrhea**, a sexually transmitted infection. Bexsero is already approved to prevent a different disease, meningitis B, and this study will see if it can also help with gonorrhea. The trial involves adults 18-50 who are at higher risk for gonorrhea. Participants are randomly given either the vaccine or a placebo (a fake shot). Neither the participant nor the study staff know who gets what, making it "observer-blind." The study lasts about **16 months** for each participant, but takes around **36 months** to complete. Participants have several visits, including blood tests and swabs for testing. To join, you must be healthy, not pregnant, and willing to follow study rules. You cannot have received this vaccine before or have certain health conditions. The study aims to show if Bexsero can stop gonorrhea infections.

  • The study lasts around 16 months for each participant.
  • Participants need to attend several visits for tests and vaccinations.
  • Participants must be healthy and free of certain infections to join.
Study details
    Gonococcal Infection

NCT04350138

National Institute of Allergy and Infectious Diseases (NIAID)

17 November 2024

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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