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Vaccine

MenABCWY Vaccine for Meningococcal Meningitis

Phase 2
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants or/and participants' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
Written or witnessed/thumb printed informed consent obtained from the participant/parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline (day 1), 1 month after the first dose of menabcwy (day 31) and 1 month after second dose of menabcwy (day 751 for the abcwy-24 group and day 1471 for the abcwy-48 group)
Awards & highlights

Study Summary

This trial will test a new vaccine to see if it is safe and effective against meningococcal disease, which is a serious infection.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include typical reactions at the injection site like pain, redness, swelling, as well as fever, headache, fatigue and muscle pain. These are common responses to vaccines but can vary between individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You and your parent/legal representative are willing and able to follow the study's rules and requirements, as determined by the investigator.
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You or your legal guardian have given written or thumbprint consent before any study procedure is performed.
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Before any study-specific procedures are done, you must give written permission to participate (if you're able to do so).
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I am between 11 and 14 years old.
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You are determined to be in good health by a doctor's evaluation before starting the study.
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I am a woman who cannot become pregnant due to surgery or being before puberty.
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You have used birth control for at least 30 days before getting the first vaccine.
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Women must have a negative pregnancy test on the day they receive the vaccine.
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Female participants of childbearing age need to use effective birth control for 30 days before and after each vaccination. They will also need to provide urine samples to confirm they are not pregnant before each vaccination.
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I am [your height in inches] inches tall.
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I weigh... pounds.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 month after the second dose of menabcwy (day 751 for the abcwy-24 group and day 1471 for the abcwy-48 group)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 month after the second dose of menabcwy (day 751 for the abcwy-24 group and day 1471 for the abcwy-48 group) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs
Percentage of participants with any unsolicited adverse events (AEs) including all serious adverse events (SAEs), AEs leading to withdrawal, adverse events of special interest (AESIs) and medically attended AEs
Percentage of participants with hSBA titers ≥ LLOQ for each N. meningitidis serogroup B indicator strains
+3 more
Secondary outcome measures
Percentage of participants with hSBA titers ≥ LLOQ for N. meningitidis serogroups A, C, W and Y
Percentage of participants with hSBA titers ≥ LLOQ for each N. meningitidis serogroup B indicator strains and for serogroups A, C, W and Y

Side effects data

From 2018 Phase 2 trial • 520 Patients • NCT03587207
98%
Injection site pain
71%
Fatigue
68%
Erythema
61%
Swelling
55%
Headache
52%
Induration
47%
Myalgia
28%
Arthralgia
25%
Nausea
7%
Pyrexia
5%
Injection site induration
3%
Nasopharyngitis
3%
Upper respiratory tract infection
3%
Injection site erythema
2%
Concussion
2%
Syncope
2%
Injection site swelling
2%
Migraine
1%
Toothache
1%
Abdominal pain
1%
Viral infection
1%
Gastritis
1%
Back pain
1%
Thermal burn
1%
Urticaria
1%
Diarrhoea
1%
Dizziness
1%
Lyme disease
1%
Respiratory tract infection viral
1%
Oral herpes
1%
Eczema
1%
Oropharyngeal pain
1%
Head injury
1%
Pharyngitis streptococcal
1%
Limb injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
rMenBOMV+ACWY_S Group
MenABCWY Group
rMenBOMV+ACWY_D Group
rMenBOMV Group
MenACWY Group

Trial Design

2Treatment groups
Experimental Treatment
Group I: ABCWY-48 GroupExperimental Treatment2 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 GroupExperimental Treatment2 Interventions
Participants receive 2 doses of the MenABCWY vaccine at Day 1 and Day 721, 1 dose of Placebo at Day 1441.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MenABCWY vaccine
2021
Completed Phase 3
~1770
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,748 Previous Clinical Trials
8,067,067 Total Patients Enrolled
5 Trials studying Meningococcal Meningitis
3,513 Patients Enrolled for Meningococcal Meningitis

Media Library

MenABCWY vaccine (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05087056 — Phase 2
Meningococcal Meningitis Research Study Groups: ABCWY-24 Group, ABCWY-48 Group
Meningococcal Meningitis Clinical Trial 2023: MenABCWY vaccine Highlights & Side Effects. Trial Name: NCT05087056 — Phase 2
MenABCWY vaccine (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05087056 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people with the relevant illness able to sign up for this trial at this time?

"That is accurate. The listing on clinicaltrials.gov says that the trial is still looking for patients. This trial was originally posted on December 29th, 2021 and was last edited on October 20th, 2022. They are looking for 300 individuals total at 24 different sites."

Answered by AI

In this particular study, are the participants restricted to a certain age group?

"This trial is only for adolescents aged 11 to 14. There are 13 other clinical trials for minors and 24 for elderly patients."

Answered by AI

At how many distinct research sites is this trial being conducted?

"There are two dozen hospitals running this study nationwide. A few examples of locations where you can enroll are Missoula, Endwell and Charlotte. You can pick the location nearest to you to help reduce travel time and costs."

Answered by AI

What are the odds of contracting complications from the MenABCWY vaccine?

"While there is some evidence of the MenABCWY vaccine's safety, it has not been proven effective yet and thus receives a score of 2."

Answered by AI

Would I be able to participate in this clinical study?

"This trial is looking for 300 participants between the ages of 11 and 14 who have meningitis or meningococcal. The following criteria must also be met: Participants or/and participants' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol., Written or witnessed/thumb printed informed consent obtained from the participant/parent(s)/LAR(s) of the participant prior to performance of any study specific procedure., Written informed assent obtained from the participant (if applicable) prior"

Answered by AI

Who else is applying?

What state do they live in?
Utah
Nebraska
How old are they?
< 18
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
~167 spots leftby Feb 2027