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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)

Summary

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.

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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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 2023 Phase 3 trial • 1250 Patients • NCT04707391
84%
Administration site pain
52%
Headache
51%
Fatigue
22%
Myalgia
21%
Nausea
15%
COVID-19
11%
Arthralgia
9%
Administration site induration
8%
Administration site erythema
8%
Administration site swelling
4%
Pyrexia
3%
Upper respiratory tract infection
2%
Diarrhoea
2%
Anxiety
2%
Influenza
2%
Nasopharyngitis
2%
Urinary tract infection
2%
Oropharyngeal pain
1%
Pharyngitis
1%
Dysmenorrhoea
1%
Tooth impacted
1%
Vomiting
1%
Seasonal allergy
1%
Pain in extremity
1%
Attention deficit hyperactivity disorder
1%
Dizziness
1%
Asthma
1%
Acne
1%
Iron deficiency
1%
Sinusitis
1%
Cough
1%
Abdominal pain upper
1%
Nasal congestion
1%
Chlamydial infection
1%
Pharyngitis streptococcal
1%
Viral upper respiratory tract infection
1%
Depression
1%
Dermatitis contact
1%
Back pain
1%
Concussion
1%
Joint injury
1%
Ligament sprain
1%
Skin laceration
100%
80%
60%
40%
20%
0%
Study treatment Arm
ABCWY Group
ACWY 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
4,802 Previous Clinical Trials
8,377,702 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
~133 spots leftby Feb 2027
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