What is the mechanism of action of this treatment?

The most common treatments for Meningococcal Disease include vaccines like Bexsero, which target Neisseria meningitidis group B. These vaccines work by introducing antigens, such as recombinant proteins and outer membrane vesicles, that stimulate the body's immune system to produce antibodies against the bacteria. This immune response helps prevent infection by recognizing and neutralizing the pathogen if exposed in the future. This is crucial for Meningococcal Disease patients as it provides immunity and reduces the risk of severe complications, such as meningitis and septicemia, which can be life-threatening.

What side effects are associated with this type of intervention?

Common side effects of meningococcal vaccines like Bexsero, which target Neisseria meningitidis group B, include local reactions at the injection site such as pain, redness, and swelling. Systemic reactions may involve fever, headache, fatigue, and muscle or joint pain. Serious side effects are rare but can include severe allergic reactions.

What prior FDA approvals exist?

The FDA has approved several vaccines for the prevention of Meningococcal Disease, including Bexsero and Trumenba, both of which target Neisseria meningitidis group B. Bexsero (rMenB+OMV NZ) is designed to induce an immune response against group B meningococcal bacteria. Trumenba is another vaccine that targets group B and works similarly by inducing an immune response. These vaccines are part of a broader effort to prevent Meningococcal Disease, which also includes vaccines targeting other serogroups such as A, C, W, and Y.

What other types of research exist?

Promising novel alternatives to Bexsero for Meningococcal Disease patients include Trumenba (a bivalent rLP2086 vaccine) which targets factor H binding protein (fHbp) of Neisseria meningitidis group B. Additionally, ongoing research into multivalent vaccines that cover multiple serogroups, including group B, may provide broader protection in the future.

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Vaccine

Meningitis Vaccines for Infants

Phase 3

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

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

Must have

A male or female between, and including, 42 and 84 days of age (i.e., 6 through 12 weeks) at the time of the 1st vaccination

Be younger than 18 years old

Must not have

Neuroinflammatory disorders, congenital and peripartum neurological conditions, encephalopathies, seizures

Received a dose of DTPa-HBV-IPV, HRV, MMR, VV and/or Hib at any time prior to informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 month after the 4th vaccination (day 331) versus pre-4th vaccination (day 301)

Awards & highlights

Pivotal Trial

Summary

This trial is testing the safety and effectiveness of a vaccine in North American infants. The vaccine helps their immune system recognize and fight off harmful bacteria that can cause serious infections like meningitis. The study also ensures that infants receive their other routine vaccines on schedule.

Who is the study for?

Healthy infants aged 6 to 12 weeks, born full-term and with no immune system issues or severe allergies. They must not have received certain vaccines or blood products from birth, nor have chronic illnesses or conditions that could increase study risks.

What is being tested?

The trial tests the safety and effectiveness of Bexsero (meningococcal group B vaccine) given alongside PCV13 (pneumococcal conjugate vaccine) and other routine infant vaccines to see if they work well together without causing harm.

What are the potential side effects?

Possible side effects include reactions at the injection site like pain and swelling, fever, irritability, sleepiness, appetite changes, headache, joint pain, diarrhea, vomiting and muscle aches.

Eligibility Criteria

Inclusion Criteria

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

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My child is between 6 and 12 weeks old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a brain disorder such as epilepsy or encephalopathy.

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I have received vaccines like DTPa, Hepatitis B, Polio, Rotavirus, MMR, Chickenpox, or Hib before giving consent.

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I have never received cancer treatment or immunotherapy since birth.

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I have or had a disease caused by N. meningitidis.

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I have received the meningococcal B or pneumococcal vaccine before.

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My health condition is getting worse or is not under control.

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My immune system does not work properly due to a health condition.

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I have received blood products or immunoglobulins since I was born.

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I have conditions that prevent me from getting shots or having blood drawn.

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I have been on steroids for more than 14 days since birth.

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I have a birth defect in my digestive system that could lead to bowel twisting.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at one month after the 3rd vaccination (day 151) and one month after 4th vaccination (day 331)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at one month after the 3rd vaccination (day 151) and one month after 4th vaccination (day 331)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at one month after the 3rd vaccination (day 151) and one month after 4th vaccination (day 331) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Antibody Geometric Mean Concentrations (GMC) using electrochemiluminescence (ECL) assay for each of the 13 PCV13 antigens

Percentages of subjects with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs

Percentages of subjects with all unsolicited AEs

+7 more

Secondary study objectives

Antibody GMCs using ECL for each of the 13 PCV13 serotypes

Pertussis vaccine

GMCs for Anti-HBsAg antibodies

+20 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MenB+PCV GroupExperimental Treatment8 Interventions

Approximately 800 subjects enrolled in this group will receive rMenB+OMV NZ (Bexsero) concomitantly with PCV13 (Prev-nar13) and other RIV (Pediarix, Hiberix, Rotarix, M-M-R II, Varivax) at 2, 4, 6 and 12 months of age. Subjects who have received 3 PCV13 doses before 12 months of age but have not received their fourth booster dose will either receive PCV13 or PCV20 at 12 months of age (Visit 5).

Group II: Placebo+PCV GroupPlacebo Group8 Interventions

Approximately 400 subjects enrolled in this group will receive PCV13 concomitantly with placebo and other RIV at 2, 4, 6 and 12 months of age. Subjects who have received 3 PCV13 doses before 12 months of age but have not received their fourth booster dose will either receive PCV13 or PCV20 at 12 months of age (Visit 5).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

M-M-R II

2012

Completed Phase 3

~27980

Varivax

2012

Completed Phase 3

~20430

Prevnar13

2016

Completed Phase 4

~2460

Pediarix

2004

Completed Phase 3

~127860

Hiberix

2006

Completed Phase 3

~3790

Rotarix

2003

Completed Phase 4

~11900

0 / 12Eligibility 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 include vaccines like Bexsero, which target Neisseria meningitidis group B. These vaccines work by introducing antigens, such as recombinant proteins and outer membrane vesicles, that stimulate the body's immune system to produce antibodies against the bacteria. This immune response helps prevent infection by recognizing and neutralizing the pathogen if exposed in the future. This is crucial for Meningococcal Disease patients as it provides immunity and reduces the risk of severe complications, such as meningitis and septicemia, which can be life-threatening.