MenABCWY Vaccine for Meningococcal Meningitis

Recruiting at 30 trial locations

Overseen By EU GSK Clinical Trials Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: GlaxoSmithKline

Must not be taking: Corticosteroids, Antineoplastics, Immunomodulators, others

Disqualifiers: Neuroinflammatory, Autoimmune, Immunodeficiency, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 48 months

300 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new vaccine that protects against five types of bacteria causing serious infections. It targets people at risk of these infections and works by helping their immune system recognize and fight the bacteria.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on certain immune-modifying drugs or investigational products, you may need to stop them before joining the study. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of the MenABCWY vaccine for meningococcal meningitis?

The MenACYW-TT vaccine, which is similar to MenABCWY, showed superior immune responses in toddlers for meningococcal serogroup C compared to other vaccines, indicating its potential effectiveness in preventing meningococcal disease. ^{1 2 3 4 5}

Is the MenABCWY vaccine safe for humans?

The MenABCWY vaccine has been tested in several studies and has shown an acceptable safety profile, with no major safety concerns reported. Some mild side effects like injection site pain and fever were noted, but serious adverse events were rare and not related to the vaccine. ^{6 7 8 9 10}

How is the MenABCWY vaccine different from other treatments for meningococcal meningitis?

The MenABCWY vaccine is unique because it combines components from two existing vaccines to protect against all five major serogroups of meningococcal bacteria, potentially simplifying the vaccination schedule compared to using separate vaccines for different serogroups. ^{6 8 10 11 12}

Eligibility Criteria

This trial is for healthy boys and girls aged 11 to 14 who haven't started their periods, had certain surgeries or are not pregnant. They must be willing to use birth control around the time of vaccination and follow the study rules. Consent from them or a guardian is needed.

Inclusion Criteria

I am between 11 and 14 years old.

You or your legal guardian have given written or thumbprint consent before any study procedure is performed.

Before any study-specific procedures are done, you must give written permission to participate (if you're able to do so).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the MenABCWY vaccine on different dosing schedules

48 months

3 visits (in-person) at Day 1, Day 721, and Day 1441

Follow-up

Participants are monitored for safety and effectiveness after each vaccination

6 months after first vaccination

Long-term follow-up

Antibody persistence is evaluated 25 months after the second dose

25 months after second dose

Treatment Details

Interventions

• MenABCWY vaccine

Trial Overview The MenABCWY vaccine, designed to protect against five types of meningococcal disease, is being tested for safety and immune response in adolescents. Participants will either receive this vaccine or a placebo according to different dosing schedules.

Participant Groups

Group I: ABCWY-48 Group Experimental Treatment 2 Interventions

Participants receive 2 doses of the MenABCWY vaccine at Day 1 and Day 1441, 1 dose of Placebo at Day 721.

Group II: ABCWY-24 Group Experimental Treatment 2 Interventions

Participants receive 2 doses of the MenABCWY vaccine at Day 1 and Day 721, 1 dose of Placebo at Day 1441.

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

References

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

Comparing the meningococcal serogroup C immune response elicited by a tetanus toxoid conjugate quadrivalent meningococcal vaccine (MenACYW-TT) versus a quadrivalent or monovalent C tetanus toxoid conjugate meningococcal vaccine in healthy meningococcal vaccine-naïve toddlers: A randomised, controlled trial. [2022]

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

A Licensed Combined Haemophilus influenzae Type b-Serogroups C and Y Meningococcal Conjugate Vaccine. [2021]

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

Meningococcal serogroup B-specific responses after vaccination with bivalent rLP2086: 4 year follow-up of a randomised, single-blind, placebo-controlled, phase 2 trial. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Treatment outcomes in persons with severe haemophilia B in the Nordic region: The B-NORD study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

rFVIII-Fc in severe haemophilia A: The incentive switch in case of high risk of joint bleedings. [2022]

6. 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]

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

Results from a large post-marketing safety surveillance study in the Republic of Korea with a quadrivalent meningococcal CRM-conjugate vaccine in individuals aged 2 months-55 years. [2021]

8. 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]

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

A Decade of Fighting Invasive Meningococcal Disease: A Narrative Review of Clinical and Real-World Experience with the MenACWY-CRM Conjugate Vaccine. [2022]

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

Immunogenicity and safety of investigational vaccine formulations against meningococcal serogroups A, B, C, W, and Y in healthy adolescents. [2018]

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

Immunogenicity and safety of different schedules of the meningococcal ABCWY vaccine, with assessment of long-term antibody persistence and booster responses - results from two phase 2b randomized trials in adolescents. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of a quadrivalent meningococcal polysaccharide CRM conjugate vaccine in infants and toddlers. [2022]