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Vaccine

Meningococcal ABCWY Vaccine for Meningococcal Disease

Phase 1 & 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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 31 versus day 1 in abcwy (0,6-months) and control groups, day 211 versus day 1 in abcwy (0,6-months) groups and day 211 versus day 31 in abcwy (0,2-months) groups
Awards & highlights

Study Summary

This trial is testing a new meningococcal vaccine in healthy adults to see if it is safe and effective. If it is, it will be further tested in adolescents and young adults.

Who is the study for?
Healthy adolescents and adults aged 10-25 for Phase II, and 18-50 for the 'blood sourcing' part. Participants must have had a MenACWY vaccine at least four years ago or be unvaccinated, agree to protocol requirements, use contraception if of childbearing potential, and not be pregnant.Check my eligibility
What is being tested?
The trial is testing two doses of a new meningococcal ABCWY vaccine against a placebo and other vaccines. It's in phases: first with healthy adults to check safety (Phase I), then with adolescents to find the best dose/schedule (Phase II), followed by blood sample collection.See study design
What are the potential side effects?
Potential side effects are not detailed but may include typical reactions to vaccines such as soreness at injection site, fever, fatigue, headache or allergic reactions. The study aims to ensure that these are minimal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 31 versus day 1 in abcwy (0,6-months) and control groups, day 211 versus day 1 in abcwy (0,6-months) groups and day 211 versus day 31 in abcwy (0,2-months) groups
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 31 versus day 1 in abcwy (0,6-months) and control groups, day 211 versus day 1 in abcwy (0,6-months) groups and day 211 versus day 31 in abcwy (0,2-months) groups 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 and AESIs in study Phase I (Safety Lead-in)
Percentages of participants with SAEs, AEs leading to withdrawal and AESIs in study Phase II (Formulation and Schedule-Finding)
Percentages of participants with SAEs, AEs leading to withdrawal and AESIs in study Phase II (Sourcing)
+11 more
Secondary outcome measures
Immunoglobulin G (IgG) antibodies against serogroups A, C, W and Y
Percentages of participants with 4-fold rise in hSBA titers against serogroup B indicator strains in study Phase II (Formulation and Schedule-finding)
Percentages of participants with a 4-fold rise in hSBA titers against serogroups A, C, W and Y in study Phase II (Formulation and Schedule-finding)
+7 more

Trial Design

15Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: ABCWY low dose_06 GroupExperimental Treatment2 Interventions
Participants receive MenABCWY-2Gen low dose vaccine in a 0, 6 month schedule and 1 dose of NaCl and are followed up until Day 541 in study Phase II (Formulation and Schedule-finding).
Group II: ABCWY low dose_02 GroupExperimental Treatment2 Interventions
Participants receive MenABCWY-2Gen low dose vaccine in a 0, 2 month schedule and 1 dose of NaCl and are followed up until Day 541 in study Phase II (Formulation and Schedule-finding).
Group III: ABCWY low dose_01 GroupExperimental Treatment1 Intervention
Participants receive MenABCWY-2Gen low dose vaccine in a 0,1 month schedule and are followed up until Day 211 in study Phase II (Sourcing).
Group IV: ABCWY low doseS_06 GroupExperimental Treatment1 Intervention
Participants receive MenABCWY-2Gen low dose vaccine in a 0, 6 month schedule and are followed up until Day 361 in study Phase II (Sourcing).
Group V: ABCWY low doseS_02 GroupExperimental Treatment1 Intervention
Participants receive MenABCWY-2Gen low dose vaccine in a 0, 2 month schedule and are followed up until Day 241 in study Phase II (Sourcing).
Group VI: ABCWY low dose GroupExperimental Treatment1 Intervention
Participants receive MenABCWY-2Gen low dose vaccine and are followed up until Day 211 in study Phase I.
Group VII: ABCWY high dose_06 GroupExperimental Treatment2 Interventions
Participants receive MenABCWY-2Gen high dose vaccine in a 0, 6 month schedule and 1 dose of NaCl and are followed up until Day 541 in study Phase II (Formulation and Schedule-finding).
Group VIII: ABCWY high dose_02 GroupExperimental Treatment2 Interventions
Participants receive MenABCWY-2Gen high dose vaccine in a 0,2 month schedule and 1 dose of NaCl and are followed up until Day 541 in study Phase II (Formulation and Schedule-finding).
Group IX: ABCWY high dose_01 GroupExperimental Treatment1 Intervention
Participants receive MenABCWY-2Gen high dose vaccine in a 0,1 month schedule and are followed up until Day 211 in study Phase II (Sourcing).
Group X: ABCWY high doseS_06 GroupExperimental Treatment1 Intervention
Participants receive MenABCWY-2Gen high dose vaccine in a 0, 6 month schedule and are followed up until Day 361 in study Phase II (Sourcing).
Group XI: ABCWY high doseS_02 GroupExperimental Treatment1 Intervention
Participants receive MenABCWY-2Gen high dose vaccine in a 0, 2 month schedule and are followed up until Day 241 in study Phase II (Sourcing).
Group XII: ABCWY high dose GroupExperimental Treatment1 Intervention
Participants receive MenABCWY-2Gen high dose vaccine and are followed up until Day 211 in study Phase I.
Group XIII: Control GroupActive Control3 Interventions
Participants randomized to Control Group receive 2 doses of Bexsero (MenB) vaccine and 1 dose of Menveo (MenACWY), 1 dose of NaCl and are followed up until Day 541 in study Phase II (Formulation and Schedule-finding).
Group XIV: Placebo high dose GroupPlacebo Group1 Intervention
Participants receive NaCl as a control for ABCWY high dose group and are followed up until Day 211 in study Phase I.
Group XV: Placebo low dose GroupPlacebo Group1 Intervention
Participants receive NaCl as a control for ABCWY low dose group and are followed up until Day 211 in study Phase I.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,751 Previous Clinical Trials
8,066,043 Total Patients Enrolled
11 Trials studying Meningococcal Disease
7,724 Patients Enrolled for Meningococcal Disease
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,142,501 Total Patients Enrolled
7 Trials studying Meningococcal Disease
5,443 Patients Enrolled for Meningococcal Disease

Media Library

MenABCWY-2Gen high dose vaccine (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04886154 — Phase 1 & 2
Meningococcal Disease Research Study Groups: ABCWY high doseS_06 Group, ABCWY high dose_02 Group, Placebo high dose Group, ABCWY low dose_06 Group, ABCWY high dose_01 Group, Placebo low dose Group, ABCWY high dose Group, ABCWY low doseS_02 Group, ABCWY low dose_02 Group, ABCWY low dose_01 Group, ABCWY high dose_06 Group, Control Group, ABCWY low dose Group, ABCWY high doseS_02 Group, ABCWY low doseS_06 Group
Meningococcal Disease Clinical Trial 2023: MenABCWY-2Gen high dose vaccine Highlights & Side Effects. Trial Name: NCT04886154 — Phase 1 & 2
MenABCWY-2Gen high dose vaccine (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04886154 — Phase 1 & 2
Meningococcal Disease Patient Testimony for trial: Trial Name: NCT04886154 — Phase 1 & 2

Frequently Asked Questions

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

What are the main goals that this medical study is aiming to achieve?

"The primary aim of this study, which will be assessed over a 30-day period following vaccination at Day 31, is to gauge the percentage of participants who experience serious adverse events (SAEs), adverse effects resulting in withdrawal from the trial and any AESIs. Secondary objectives encompass calculating percentages of those with 4-fold increases in hSBA titres against serogroup B indicator strains relative to day 1 for ABCWY groups on 0.6 month schedule and day 31 for ABCWY groups on 0.2 month schedule; determining what proportion of subjects have hSBA readings above limit of quantification (LLOQ) across"

Answered by AI

Is there still space available for participants in this research endeavor?

"As this clinical trial has since closed its recruitment period, which began on June 14th 2021 and ended October 20th 2022, patients seeking to join a study should look at the presently 13 studies looking for participants with meningococcal infections or any of the 20 trials recruiting people for a MenABCWY-2Gen low dose vaccine."

Answered by AI

Am I eligible to partake in this medical research program?

"To be eligible for this research, participants must have been diagnosed with meningococcal infections and should fall within the age range of 10 to 50. This clinical trial has a target enrolment goal of 1258 individuals."

Answered by AI

How many individuals have taken part in the experiment thus far?

"Currently, this study is not accepting applications. The trial was issued on 14th June 2021 and most recently updated on 20th October 2022. Those hoping to participate in a clinical trial can investigate the 13 trials researching meningococcal infections or the 20 studies focusing on MenABCWY-2Gen low dose vaccine which are both actively looking for volunteers."

Answered by AI

Does the eligibility criterion for this experiment extend to younger patients?

"As detailed in the trial's enrollment requirements, would-be participants must be between 10 and 50 years of age."

Answered by AI

What states are hosting the trial's implementation?

"At present, this clinical trial has 13 sites across the United States. Examples include Miami Lakes, Colorado Springs and Cincinnati. To reduce travel demands for patients, it is recommended to choose a testing site close by."

Answered by AI

What has the research revealed regarding MenABCWY-2Gen low dose vaccine?

"The MenABCWY-2Gen low dose vaccine was first evaluated in 2013 at The Rockefeller University. Since then, 18453 trials have been finished and 20 are presently ongoing with much of the recruitment being done out of Miami Lakes, Colorado."

Answered by AI

Who else is applying?

What state do they live in?
Nebraska
What site did they apply to?
GSK Investigational Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

What is the pay? How many visits? What is the address of the research trial site in Lincoln, Nebraska?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I need the money.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Average response time
  • < 1 Day
Most responsive sites:
  1. GSK Investigational Site: < 24 hours
Recent research and studies
clinicaltrials.govStudy
A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults
2021. "A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04886154.
~373 spots leftby Apr 2025
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