MenABCWY vaccine for Meningitis, Meningococcal

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Meningitis, Meningococcal+1 More
MenABCWY vaccine - CombinationProduct
Eligibility
< 65
All Sexes
What conditions do you have?
Select

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
  • Meningitis, Meningococcal

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

6 Primary · 7 Secondary · Reporting Duration: 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

Month 1
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
Month 1
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
Month 1
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
Month 1
Percentages of participants with hSBA titers ≥ Lower Limit of Quantitation (LLOQ) against serogroups A, C, W, and Y at day 1, 1 month after the first and second MenABCWY vaccine and after the single MenACWY vaccine
Month 1
hSBA Geometric Mean Titers (GMTs) against serogroups A, C, W, and Y at day 1, 1 month after the first and second MenABCWY vaccine and after the single MenACWY vaccine
Day 211
GMTs against each serogroup B indicator strains at day 1, 1 month after second MenABCWY vaccine
Percentages of participants with hSBA titers ≥ LLOQ for each and all serogroup B indicator strains at day 1 and 1 month after the second dose of MenABCWY vaccine
At Day 211
Percentages of participants with 4-fold rise in hSBA titers against each N. meningitidis serogroup B indicator strains at 1 month after the second MenABCWY vaccine
Day 211
GMRs against each serogroup B indicator strains at 1 month after second dose of MenABCWY vaccine
Day 181
Percentages 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)
Day 181
Percentages of participants with solicited administration site events
Day 181
Percentages of participants with solicited systemic events
Day 361
Percentages of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

MenABCWY Group
94%Injection site pain
70%Fatigue
60%Headache
51%Swelling
50%Erythema
50%Myalgia
44%Induration
29%Arthralgia
24%Nausea
12%Pyrexia
5%Upper respiratory tract infection
3%Injection site swelling
2%Injection site induration
2%Tonsillitis
2%Viral infection
2%Injection site erythema
2%Vaccination complication
1%Injection site discolouration
1%Dizziness
1%Paraesthesia
1%Arthropod sting
1%Vertigo
1%Gastroenteritis
1%Inflammation
1%Toothache
1%Viral pharyngitis
1%Ligament sprain
1%Tendonitis
1%Enteritis
1%Urticaria
1%Depression
1%Sinusitis
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT03587207) in the MenABCWY Group ARM group. Side effects include: Injection site pain with 94%, Fatigue with 70%, Headache with 60%, Swelling with 51%, Erythema with 50%.

Trial Design

2 Treatment Groups

ACWY Group
1 of 2
ABCWY Group
1 of 2

Active Control

Experimental Treatment

1206 Total Participants · 2 Treatment Groups

Primary Treatment: MenABCWY vaccine · Has Placebo Group · Phase 3

ABCWY GroupExperimental Group · 2 Interventions: MenABCWY vaccine, Placebo · Intervention Types: CombinationProduct, CombinationProduct
ACWY GroupActiveComparator Group · 2 Interventions: MenB vaccine, MenACWY vaccine · Intervention Types: CombinationProduct, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MenABCWY vaccine
2018
Completed Phase 2
~520
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,640 Previous Clinical Trials
7,945,115 Total Patients Enrolled
10 Trials studying Meningitis, Meningococcal
10,691 Patients Enrolled for Meningitis, Meningococcal

Eligibility Criteria

Age < 65 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a male or female between, and including, 15 and 25 years of age (i.e., 25 years and 364 days) at the time of the first vaccination.
You have agreed to continue adequate contraception during the entire intervention period and for 30 days after completion of the vaccination series.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: November 10th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.