Pentavalent Meningococcal Vaccine for Meningococcal Disease

No longer recruiting at 83 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety and immune response of a new meningococcal vaccine in healthy adults and adolescents. The study will compare different vaccines, including the new pentavalent meningococcal ABCYW vaccine, which targets multiple strains of the meningococcal bacteria. Participants will receive various vaccines or placebos to determine which is most effective. Ideal candidates for this study are those who have never received a meningococcal vaccine or had their last shot over four years ago and are generally healthy. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage vaccine development.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the investigational pentavalent meningococcal ABCYW vaccine has a well-understood safety profile. Studies indicate it is generally well-tolerated, with only minor side effects like redness or swelling at the injection site. Strong evidence also supports that other similar meningococcal vaccines have a good safety record.

For the Sanofi MenB vaccine, data shows it is safe and effective. Most side effects are mild to moderate, such as pain or swelling at the injection site. Years of research and real-world data have not shown any major safety concerns.

Both vaccines are being evaluated for safety in this trial. Since they are in early trials, they have passed initial safety checks, but more data is needed to confirm long-term safety. Participants can expect close monitoring for any side effects during the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the pentavalent meningococcal ABCYW vaccine because it offers a broader spectrum of protection against meningococcal disease compared to current options. Unlike existing vaccines that typically target just a few strains, this new vaccine targets five key strains (A, B, C, Y, and W) in a single shot. This comprehensive approach not only simplifies the vaccination process but potentially enhances immune defense across a wider range of meningococcal bacteria. This could be a game-changer in preventing meningococcal disease, which can be severe and life-threatening.

What evidence suggests that this trial's treatments could be effective for meningococcal disease?

This trial will compare the pentavalent meningococcal ABCYW vaccine with other vaccines. Research has shown that the pentavalent meningococcal ABCYW vaccine, which participants in this trial may receive, has been tested in teenagers and young adults and is generally safe with no major safety issues. Early results suggest that using this vaccine instead of other meningococcal vaccines could save money. It is designed to protect against several types of bacteria that cause meningococcal disease.

Another treatment option in this trial is the Sanofi MenB vaccine. Studies have found that it provides strong protection against meningococcal disease, greatly reducing the number of disease cases in vaccinated babies and young children. However, limited information exists on its effectiveness in teenagers and adults. ^{2 6 7 8 9}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40494224/

Cost-effectiveness of pentavalent meningococcal ... Using the pentavalent vaccine as an alternative to the simultaneous administration of MenACWY and MenB was cost-saving, but other uses are ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06647407

Study Details | NCT06647407 | Safety and Immunogenicity ... The aim of the study is to assess 2 formulations of the MenPenta vaccine compared to licensed meningococcal vaccines when administered alone in children (Stage ...

3. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7315a4.htm

Use of the Pfizer Pentavalent Meningococcal Vaccine... This report describes recommendations for using Pfizer pentavalent meningococcal vaccines among people ages 10 years and older.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11598276/

Analytical Challenges in Novel Pentavalent Meningococcal ... A scoping review aims to identify the main challenges and gaps in analyzing multivalent vaccines, especially in the case of novel serogroups, such as X.

5. withpower.com withpower.com/trial/phase-2-meningococcal-infections-9-2023-363fe

Pentavalent Meningococcal Vaccine for ... The pentavalent meningococcal ABCWY vaccine has been tested in adolescents and young adults, showing an acceptable safety profile with no major safety ...

6. cdc.gov cdc.gov/vaccine-safety/vaccines/meningococcal.html

Meningococcal Vaccine Safety MenACWY and MenB vaccines have a favorable safety profile—the body of scientific evidence overwhelmingly supports their safety ...

7. sanofistudies.com sanofistudies.com/cwout/CW-V9DEXS//gb/en/listing/312985/safety-and-immunogenicity-of-6/

Safety and Immunogenicity of an Investigational ... The aim of the study is to assess 2 formulations of the MenPenta vaccine compared to licensed meningococcal vaccines when administered alone in children.

8. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-safety-and-immune-response-of-menpenta-vaccine-for-meningococcal-disease-in-healthy-children-toddlers-and-infants/

Safety and immunogenicity study of Pentavalent ... This clinical trial aims to evaluate the safety and effectiveness of a new vaccine called MenPenta for preventing meningococcal disease.

9. gsk.com gsk.com/en-gb/media/press-releases/gsk-s-5-in-1-meningococcal-abcwy-vaccine-candidate-accepted-for-regulatory-review-by-us-fda/

GSK's 5-in-1 meningococcal ABCWY vaccine candidate ... It offers extensive evidence of immunogenicity with a well-characterised safety profile. In the US, this vaccine has received regulatory ...