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Vaccine

MenABCWY vaccine for Meningococcal Meningitis

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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 month after the first vaccination (i.e., day 31) compared to day 1 (baseline)
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new meningitis vaccine in healthy young people aged 15 to 25 who have already had a previous meningitis shot. The goal is to see if the new vaccine is safe and helps their bodies fight off the bacteria that cause meningitis. The new vaccine is designed to protect against multiple types of meningitis.

Eligible Conditions
  • Meningococcal Meningitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 month after vaccination schedule (i.e., day 211 for abcwy group and day 31 for acwy group) compared to day 1 (baseline)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 month after vaccination schedule (i.e., day 211 for abcwy group and day 31 for acwy group) compared to day 1 (baseline) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Any Unsolicited Adverse Events (AEs) (Including All Serious Adverse Events [SAEs], AEs Leading to Withdrawal, AEs of Special Interest [AESIs] and Medically Attended AEs)
Number of Participants With Any Unsolicited Adverse Events (AEs) (Including All Serious Adverse Events [SAEs], AEs Leading to Withdrawal, AEs of Special Interest [AESIs] and Medically Attended AEs) Following Vaccination at Day 181 for ABCWY Group
Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs
+6 more
Secondary study objectives
GMRs Against Each Serogroup B Indicator Strains at 1 Month After Second Dose of MenABCWY Vaccination
GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination
Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After Second MenABCWY Vaccination
+7 more

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%
Attention deficit hyperactivity disorder
1%
Pharyngitis
1%
Dysmenorrhoea
1%
Tooth impacted
1%
Vomiting
1%
Seasonal allergy
1%
Pain in extremity
1%
Dizziness
1%
Asthma
1%
Acne
1%
Iron deficiency
1%
Cough
1%
Sinusitis
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

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
Active Control
Group I: ABCWY GroupExperimental Treatment2 Interventions
Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.
Group II: ACWY GroupActive Control2 Interventions
Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
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
4,808 Previous Clinical Trials
8,380,128 Total Patients Enrolled
5 Trials studying Meningococcal Meningitis
3,513 Patients Enrolled for Meningococcal Meningitis
~259 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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