What side effects are associated with this type of intervention?

Common side effects of meningococcal vaccines, including those targeting serogroups A, B, C, Y, and W, generally include local reactions such as pain, redness, and swelling at the injection site. Systemic reactions may involve fever, headache, fatigue, and muscle pain. Severe allergic reactions are rare but possible.

What prior FDA approvals exist?

The FDA has approved several vaccines for the prevention of Meningococcal Disease, targeting different serogroups of Neisseria meningitidis. These include the quadrivalent vaccines MenACWY (such as Menactra and Menveo), which protect against serogroups A, C, Y, and W. Additionally, vaccines like Bexsero and Trumenba have been approved to protect against serogroup B. The investigational Pentavalent Meningococcal ABCYW Vaccine aims to provide broader protection by targeting serogroups A, B, C, Y, and W in a single formulation.

What other types of research exist?

Promising novel alternatives to the Pentavalent Meningococcal ABCYW Vaccine include investigational vaccines such as the hexavalent meningococcal vaccine, which targets six serogroups (A, B, C, W, Y, and X). Additionally, ongoing research into protein-based vaccines and conjugate vaccines that offer broader protection and longer-lasting immunity are also noteworthy. These alternatives are currently in various stages of clinical trials and may provide enhanced protection against meningococcal disease.

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Cancer Vaccine

Pentavalent Meningococcal Vaccine for Meningococcal Disease

Phase 1 & 2

Waitlist Available

Research Sponsored by Sanofi Pasteur, a Sanofi Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18 to 25 years or 10 to 17 years on the day of inclusion

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to 12 months

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects could include pain at the injection site, fever, fatigue, headache, muscle pain, chills, nausea or joint pain similar to other vaccines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 10-25 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose 1 and 1 month post-last dose in adolescent participants

Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the last dose in adolescent participants

Number of participants with immediate adverse events (AEs)

+8 more

Secondary study objectives

Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (additional MenB strains) pre-dose 1 and 1 month post-last dose in adolescent participants

Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (additional MenB strains) pre-dose 1 and 1 month post-last dose in adults and adolescent participants

Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) at each timepoint

+13 more

Trial Design

7Treatment groups

Experimental Treatment

Active Control

Group I: Group 6: Sanofi MenBExperimental Treatment2 Interventions

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

Group II: Group 2: MenPenta Formulation 2Experimental Treatment2 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 1Experimental Treatment2 Interventions

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

Group IV: Group 7: PENBRAYAActive Control1 Intervention

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

Group V: Group 3: Bexsero® + Menveo®Active Control2 Interventions

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

Group VI: Group 5: MenQuadfi®Active Control2 Interventions

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

Group VII: Group 4: Trumenba® + Menveo®Active Control2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Meningococcal group B vaccine

2018

Completed Phase 3

~790

Placebo

1995

Completed Phase 3

~2670

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Meningococcal Disease, particularly vaccines like the Pentavalent Meningococcal ABCYW Vaccine, work by stimulating the immune system to recognize and combat Neisseria meningitidis. These vaccines contain polysaccharides from the bacterial capsule conjugated to a protein carrier, which enhances the immune response. This mechanism is vital for patients as it offers broad protection against multiple serogroups (A, B, C, Y, and W), significantly reducing the risk of severe infections and potential outbreaks.

The impact of administration of conjugate vaccines containing cross reacting material on Haemophilus influenzae type b antibody responses in infants: A systematic review and meta-analysis of randomised controlled trials.Immunogenicity and safety of the quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (MenACWY-TT) in 2-10-year-old children: results of an open, randomised, controlled study.