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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 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

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.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor
417 Previous Clinical Trials
6,107,657 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
872 Previous Clinical Trials
2,019,571 Total Patients Enrolled
~449 spots leftby Jun 2025