MenABCWY vaccine for Meningococcal Meningitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Meningococcal MeningitisMenABCWY vaccine - CombinationProduct
Eligibility
11 - 14
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Meningococcal Meningitis

Treatment Effectiveness

Study Objectives

6 Primary · 2 Secondary · Reporting Duration: 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)

Month 1
Percentage of participants with hSBA titers ≥ LLOQ for each N. meningitidis serogroup B indicator strains
Month 25
Percentage of participants with hSBA titers ≥ LLOQ for each N. meningitidis serogroup B indicator strains and for serogroups A, C, W and Y
At Baseline (Day 1)
Percentage of participants with human serum bactericidal assay (hSBA) titers ≥ lower limit of quantitation (LLOQ) for each N. meningitidis serogroup B indicator strains
Month 1
Percentage of participants with hSBA titers ≥ LLOQ for N. meningitidis serogroups A, C, W and Y
Day 1441
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
Month 6
Percentage of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs
Day 1441
Percentage of participants with solicited administration site events
Percentage of participants with solicited systemic events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% 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

ABCWY-48 Group
1 of 2
ABCWY-24 Group
1 of 2

Experimental Treatment

300 Total Participants · 2 Treatment Groups

Primary Treatment: MenABCWY vaccine · Has Placebo Group · Phase 2

ABCWY-48 GroupExperimental Group · 2 Interventions: Placebo, MenABCWY vaccine · Intervention Types: CombinationProduct, CombinationProduct
ABCWY-24 GroupExperimental Group · 2 Interventions: Placebo, MenABCWY vaccine · Intervention Types: CombinationProduct, CombinationProduct
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
MenABCWY vaccine
2018
Completed Phase 2
~520

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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)

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,651 Previous Clinical Trials
7,949,880 Total Patients Enrolled
5 Trials studying Meningococcal Meningitis
3,513 Patients Enrolled for Meningococcal Meningitis

Eligibility Criteria

Age 11 - 14 · All Participants · 11 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between, and including, 11 and 14 years of age (i.e
Female participants of childbearing potential will be asked to provide urine samples for pregnancy testing at visits 1, 3 and 5.
How tall are you in inches?
How much do you weigh in pounds?

Who else is applying?

What state do they live in?
Utah50.0%
Nebraska50.0%
How old are they?
< 18100.0%
What site did they apply to?
GSK Investigational Site100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%