Pentavalent Meningococcal Vaccine for Meningococcal Disease

Recruiting at81 trial locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Sanofi Pasteur, a Sanofi Company

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new vaccine that protects against five types of meningococcal bacteria in adults and adolescents. The vaccine helps the body learn to fight off these bacteria.

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

This trial is for healthy individuals aged 10-25 who may or may not have had a MenACWY vaccine at least 4 years ago. They must pass a medical evaluation including history and physical exam to participate.

Inclusion Criteria

I have not had the MenACWY vaccine or had it once over 4 years ago.

I am between 10-25 years old.

You are very healthy based on a medical check-up and the doctor's opinion.

Treatment Details

Interventions

• Pentavalent Meningococcal ABCYW vaccine (Cancer Vaccine)

Trial Overview The study tests the safety and immune response of an investigational pentavalent meningococcal ABCYW vaccine compared with other vaccines and placebo in adults and adolescents over up to 12 months.

Participant Groups

Group I: Group 6: Sanofi MenB Experimental Treatment 2 Interventions

Participants (ACWY naive and primed adults or adolescents) will receive injections of SP MenB vaccine and placebo

Group II: Group 2: MenPenta Formulation 2 Experimental Treatment 2 Interventions

Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo

Group III: Group 1: MenPenta Formulation 1 Experimental Treatment 2 Interventions

Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo

Group IV: Group 3: Bexsero® + Menveo® Active Control 2 Interventions

Participants (ACWY naive and primed adults or adolescents) will receive injections of Bexsero® + Menveo® vaccine

Group V: Group 5: MenQuadfi® Active Control 2 Interventions

Participants (ACWY naive and primed adults or adolescents) will receive injections of MenQuadfi® vaccine and placebo

Group VI: Group 7: PENBRAYA Active Control 1 Intervention

Participants (ACWY naive and primed adolescents) will receive injections of PENBRAYA vaccine and placebo

Group VII: Group 4: Trumenba® + Menveo® Active Control 2 Interventions

Participants (ACWY naive and primed adults or adolescents) will receive injections of Trumenba® + Menveo® vaccine

Who Is Running the Clinical Trial?

Sanofi Pasteur, a Sanofi Company

Lead Sponsor

Trials

429

Recruited

6,140,000+

Paul Hudson

Sanofi Pasteur, a Sanofi Company

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Dr. Thomas Triomphe

Sanofi Pasteur, a Sanofi Company

Chief Medical Officer since 2020

MD from Tehran University of Medical Sciences