Pentavalent Meningococcal Vaccine for Meningococcal Disease

Recruiting at 81 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: < 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sanofi Pasteur, a Sanofi Company

Disqualifiers: Immunodeficiency, Meningitis history, Tuberculosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 7 months

1220 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the Pentavalent Meningococcal ABCYW vaccine treatment for meningococcal disease?

Research shows that combining vaccines targeting different meningococcal serogroups, like the investigational MenABCWY vaccine, can provide broad protection against meningococcal disease. Studies indicate that these combined vaccines are effective in generating immune responses against multiple serogroups, similar to existing vaccines that target fewer serogroups. ^{1 2 3 4 5}

Is the pentavalent meningococcal ABCWY vaccine safe for humans?

The pentavalent meningococcal ABCWY vaccine has been tested in adolescents and young adults, showing an acceptable safety profile with no major safety concerns identified. One study reported a serious adverse event (fainting) in a different vaccine group, but overall, the investigational MenABCWY vaccine was considered safe. ^{5 6 7 8 9}

How does the Pentavalent Meningococcal ABCYW vaccine differ from other treatments for meningococcal disease?

The Pentavalent Meningococcal ABCYW vaccine is unique because it combines protection against all five major serogroups (A, B, C, W, and Y) of the bacteria that cause meningococcal disease, simplifying the vaccination schedule compared to using separate vaccines for different serogroups. ^{1 2 5 9 10}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injections of various meningococcal vaccines and placebos

7 months

Multiple visits for vaccinations and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 months

Regular follow-up visits

Treatment Details

Interventions

• Pentavalent Meningococcal ABCYW 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

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A comparative evaluation of two investigational meningococcal ABCWY vaccine formulations: Results of a phase 2 randomized, controlled trial. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Quadrivalent meningococcal ACYW-135 glycoconjugate vaccine for broader protection from infancy. [2009]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Vaccines against Meningococcal Diseases. [2020]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Critical appraisal of a quadrivalent CRM(197) conjugate vaccine against meningococcal serogroups A, C W-135 and Y (Menveo) in the context of treatment and prevention of invasive disease. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Immunogenicity and Safety of Investigational MenABCWY Vaccine and of 4CMenB and MenACWY Vaccines Administered Concomitantly or Alone: a Phase 2 Randomized Study of Adolescents and Young Adults. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse events following quadrivalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2016. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of a pentavalent meningococcal ABCWY vaccine in adolescents and young adults: an observer-blind, active-controlled, randomised trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Real-world evidence of quadrivalent meningococcal conjugate vaccine safety in the United States: a systematic review. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Immune Responses to Booster Vaccination With Meningococcal ABCWY Vaccine After Primary Vaccination With Either Investigational or Licensed Vaccines: A Phase 2 Randomized Study. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Public health perspective of a pentavalent meningococcal vaccine combining antigens of MenACWY-CRM and 4CMenB. [2022]