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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 vaccination schedule (i.e., day 31 for abcwy group [first dose] and acwy group, day 211 for abcwy group [second dose]) versus day 1
Awards & highlights

Study Summary

This trial will evaluate whether a new meningitis vaccine is safe and effective in people who have previously been vaccinated against 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)
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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentages of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs
Percentages of participants with a 4-fold rise in hSBA titers against N. meningitidis serogroups A, C, W, and Y at 1 month after the second MenABCWY vaccine and after the single MenACWY vaccine
Percentages of participants with a 4-fold rise in human serum bactericidal assay (hSBA) titers against N. meningitidis serogroups A, C, W, and Y at 1 month after the first MenABCWY vaccine and after the single MenACWY vaccine
+3 more
Secondary outcome measures
GMRs against each serogroup B indicator strains at 1 month after second dose of MenABCWY vaccine
GMTs against each serogroup B indicator strains at day 1, 1 month after second MenABCWY vaccine
Geometric mean ratios (GMRs) against serogroups A, C, W, and Y at 1 month after the first and second MenABCWY vaccine and after the single MenACWY vaccine
+4 more

Side effects data

From 2018 Phase 2 trial • 520 Patients • NCT03587207
94%
Injection site pain
70%
Fatigue
60%
Headache
51%
Swelling
50%
Myalgia
50%
Erythema
44%
Induration
29%
Arthralgia
24%
Nausea
12%
Pyrexia
5%
Upper respiratory tract infection
3%
Injection site swelling
2%
Injection site erythema
2%
Injection site induration
2%
Tonsillitis
2%
Vaccination complication
2%
Viral infection
1%
Paraesthesia
1%
Ligament sprain
1%
Dizziness
1%
Depression
1%
Toothache
1%
Enteritis
1%
Tendonitis
1%
Urticaria
1%
Injection site discolouration
1%
Sinusitis
1%
Arthropod sting
1%
Vertigo
1%
Gastroenteritis
1%
Inflammation
1%
Viral pharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
MenABCWY Group
rMenBOMV+ACWY_S Group
rMenBOMV+ACWY_D Group
rMenBOMV Group
MenACWY Group

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ABCWY GroupExperimental Treatment2 Interventions
All participants in this group receive 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
All participants in this group receive 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
4,742 Previous Clinical Trials
8,065,111 Total Patients Enrolled
5 Trials studying Meningococcal Meningitis
3,513 Patients Enrolled for Meningococcal Meningitis

Frequently Asked Questions

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

What other research studies have used the MenABCWY vaccine?

"There are 20 clinical trials active that involve the MenABCWY vaccine. Of these, 12 have reached Phase 3. The majority of research related to this vaccine is being conducted in Newmarket, Ontario; however, there 726 total locations running trials for MenABCWY across the world."

Answered by AI

To whom does this opportunity to participate in this research project extend?

"This study is designed for 15 to 25-year-olds who have meningitis or meningococcal. There is space for around 1206 patients in total."

Answered by AI

Will this experiment still be enrolling patients?

"Although this particular trial is not currently looking for patients, information from clinicaltrials.gov suggests that it was actively recruiting at some point in the past. The last update to the posting was on June 1st, 2022. There are presently 53 other trials seeking participants."

Answered by AI

Is this research project studying individuals below the age of 55?

"This trial is specifically for patients aged 15 to 25. There are 27 other clinical trials available for minors and 31 trials open to adults 65 and older."

Answered by AI

What has been found in terms of MenABCWY vaccine safety?

"There is a fair amount of data supporting the safety of MenABCWY vaccine--both in terms of efficacy and general safety. Consequently, we've given it a 3."

Answered by AI

How many test subjects are in this research?

"This particular trial is not currently looking for patients. The study was first posted on January 25th, 2021 and updated June 1st, 2022. If you are seeking other studies, there are 33 trials actively searching for patients with meningitis, meningococcal and 20 studies for MenABCWY vaccine that are still recruiting participants."

Answered by AI

What are the main goals of this medical study?

"The primary outcome of this clinical trial is the percentage of participants with a 4-fold rise in hSBA titers against N. meningitidis serogroups A, C, W, and Y at 1 month after vaccination. Secondary outcomes include the percentages of participants with 4-fold rises in hSBA titers against each N. meningitidis serogroup B indicator strain at 1 month after vaccination, as well as the percentages of participants with hSBA titers ≥ Lower Limit of Quantitation (LLOQ) against serogroups A, C, W, and Y at day 1,"

Answered by AI
~300 spots leftby Mar 2025