What side effects are associated with this type of intervention?

The most common side effects of meningococcal vaccines like rMenB+OMV NZ and MenACWY include injection site reactions (such as pain, redness, and swelling), fever, headache, fatigue, and muscle pain. These side effects are generally mild to moderate and resolve within a few days. Serious adverse events are rare but can include severe allergic reactions. Post-licensure surveillance has shown a low rate of serious adverse events, consistent with findings from clinical trials.

What prior FDA approvals exist?

The FDA has approved several vaccines for the prevention of Meningococcal Disease, which stimulate the immune system to produce antibodies against Neisseria meningitidis. These include the MenACWY conjugate vaccines (such as Menactra and Menveo) that target serogroups A, C, W, and Y, and the MenB vaccines (such as Bexsero and Trumenba) that target serogroup B. These vaccines are designed to provide broad protection against the most common serogroups of meningococcal bacteria responsible for invasive disease.

What other types of research exist?

Promising novel alternatives for meningococcal disease treatment in 2024 include the development of new conjugate vaccines that target additional serogroups beyond those covered by MenACWY, such as MenB-FHbp and MenB-4C. These vaccines have shown efficacy in producing robust immune responses. Additionally, research into intranasal delivery methods for meningococcal vaccines is ongoing, which may offer improved mucosal immunity and ease of administration.

← Back to Search

Vaccine

Combination Vaccines for Meningococcal Disease

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

Previous vaccination with 1 dose of quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo or Menactra) at least 4 years prior to informed consent and assent as applicable.

Written or /witnessed/thumb printed informed consent obtained from the subject/parent(s)/LAR(s) of the subject prior to performance of any study specific procedure.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during the 30 days (including day of vaccination) after each vaccination (administered at day 1, day 61 and day 91)

Awards & highlights

Pivotal Trial

Summary

This trial is testing two vaccines that protect against meningococcal disease in healthy teenagers. The vaccines help the body produce antibodies to fight off the bacteria. The study aims to see how well these vaccines work and how safe they are when given together.

Who is the study for?

Healthy individuals aged 16-18 who've had a MenACWY vaccine at least 4 years ago can join. They must not be pregnant, breastfeeding, or have autoimmune disorders, seizures, or meningococcal infection history. Participants agree to use contraception and follow the study rules.

What is being tested?

The trial is testing the safety and immune response of two vaccines given together: GSK's Meningococcal Group B Vaccine (rMenB+OMV NZ) and MenACWY Conjugate Vaccine in teens. Some may receive a placebo instead to compare results.

What are the potential side effects?

Possible side effects include pain at injection site, fever, fatigue, headache, nausea or muscle pain. Serious allergic reactions are rare but possible with any vaccine.

Eligibility Criteria

Inclusion Criteria

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

Select...

The person giving the consent or assent must have received one dose of the quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo or Menactra) at least 4 years prior.

Select...

We got written or thumbprinted consent from the subject or their parents or legal guardians before doing any study-specific procedures.

Select...

You need to take a pregnancy test before getting the vaccine and it should be negative.

Select...

has agreed to continue using contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Select...

We will get written consent from the subject (if applicable) and the subject's parent(s)/LAR(s) before doing any study-specific procedures.

Select...

The person has been using contraception for the past month in order to avoid becoming pregnant.

Select...

Before entering the study, the subjects were determined to be healthy by reviewing their medical history and conducting a clinical examination.

Select...

You or your child have an autoimmune disorder or a weakened immune system.

Select...

You or your child experience seizures on a regular basis.

Select...

Have you or your child ever had an infection called meningococcal?

Select...

Have you or your child received a meningococcal vaccine before?

Select...

Are you currently pregnant or breastfeeding?

Select...

You and/or your legal representative are willing and able to follow the instructions of the study as directed by the investigator.

Select...

You are between 16 and 18 years old when you receive your first vaccine.

Select...

Women who cannot become pregnant may participate in the study. This includes women who have not started their menstrual periods, had their tubes tied, had their uterus or ovaries removed, or have gone through menopause.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the 30 days (including day of vaccination) after each vaccination (administered at day 1, day 61 and day 91)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the 30 days (including day of vaccination) after each vaccination (administered at day 1, day 61 and day 91)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the 30 days (including day of vaccination) after each vaccination (administered at day 1, day 61 and day 91) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Human Serum Bactericidal Assay Geometric Mean Titers (GMTs) against each of the N. meningitidis serogroup B strains after the second vaccination with rMenB+OMV NZ

Percentage of subjects with AESI

Percentage of subjects with adverse events of special interest (AESI)

+6 more

Secondary study objectives

Geometric mean ratios (GMRs) against each of the N. meningitidis serogroup A, C, W and Y in both MenB+MenACWY and MenACWY Groups after MenACWY vaccination.

Geometric mean ratios (GMRs) against each of the N. meningitidis serogroup B strains in both MenB+MenACWY and MenB Groups after the first rMenB+OMV NZ dose.

Geometric mean ratios (GMRs) against each of the N. meningitidis serogroup B strains in both MenB+MenACWY and MenB Groups after the second rMenB+OMV NZ dose

+8 more

Awards & Highlights

Pivotal Trial

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: MenB+MenACWY GroupExperimental Treatment3 Interventions

Subjects will receive 1 dose rMenB+OMV NZ given concomitantly with MenACWY at Day 1, 1 dose of rMenB+OMV NZ at Day 61 and 1 dose of placebo at Day 91.

Group II: MenB GroupExperimental Treatment3 Interventions

Subjects will receive 1 dose of rMenB+OMV NZ and placebo concomitantly at Day 1, 1 dose of rMenB+OMV NZ at Day 61 and 1 dose of MenACWY at Day 91.

Group III: MenACWY GroupExperimental Treatment3 Interventions

Subjects will receive 1 dose of MenACWY and placebo concomitantly at Day 1, 1 dose of rMenB+OMV NZ each at Day 61 and at Day 91.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ)

2020

Completed Phase 3

~950

Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid)

2020

Completed Phase 3

~950

Placebo

1995

Completed Phase 3

~2670

0 / 15Eligibility 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 rMenB+OMV NZ and MenACWY vaccines work by stimulating the immune system to produce antibodies against meningococcal bacteria. The rMenB+OMV NZ vaccine targets serogroup B using outer membrane vesicles and recombinant proteins, while the MenACWY vaccine targets serogroups A, C, W, and Y using polysaccharide-protein conjugates. This broad protection is crucial for preventing severe infections and outbreaks of Meningococcal Disease.

Prevention of Neisseria gonorrhoeae with meningococcal B vaccine: a matched cohort study in Southern California.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.