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A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults

NCT04886154 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1440

Last updated 2025-05-31

Study results available
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Summary

The purpose of this study was to assess the safety, effectiveness, and immune response of the meningococcal combined ABCWY vaccine (GSK4023393A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups. The first time-in-human (FTIH), Phase I part of this study was conducted in healthy adults in a dose-escalating fashion with 2 formulations of the investigational MenABCWY-2Gen vaccine and served as a safety lead-in to the Phase II study. The Phase II part of the study was conducted in 2 parts: The 'formulation and schedule-finding' part followed in healthy adolescents and young adults and was designed to select the vaccine formulation and the schedule to be tested in Phase III. The 'blood sourcing' part was conducted in healthy adults in order to collect sufficient serum samples for the development of assays to be used in the MenABCWY-2Gen vaccine clinical development program.

Conditions

  • Infections, Meningococcal

Interventions

COMBINATION_PRODUCT

MenABCWY-2Gen low dose vaccine

MenABCWY-2Gen low dose vaccine is administered intramuscularly as 2 doses to participants in the ABCWY low dose Group in study Phase I, ABCWY low dose\_06 Group and ABCWY low dose\_02 Group in study Phase II (Formulation and Schedule-finding) and as 2 doses to participants in the ABCWY low dose\_01 Group, ABCWY low doseS\_02 Group and ABCWY low doseS\_06 Group in study Phase II (Sourcing).

COMBINATION_PRODUCT

MenABCWY-2Gen high dose vaccine

MenABCWY-2Gen high dose vaccine is administered intramuscularly 2 doses to participants in the ABCWY high dose Group in study Phase I, ABCWY high dose\_06 Group and ABCWY high dose\_02 Group in study Phase II (Formulation and Schedule-finding) and as 2 doses to participants in the ABCWY high dose\_01 Group, ABCWY high doseS\_02 Group and ABCWY high doseS\_06 Group in study Phase II (Sourcing).

COMBINATION_PRODUCT

Placebo

Placebo is administered intramuscularly as 2 doses to participants in the Placebo low dose Group, Placebo high dose Group in study Phase I and as 1 dose to participants in the ABCWY low dose\_06 Group, ABCWY low dose\_02 Group, ABCWY high dose\_06 Group, ABCWY high dose\_02 Group in study Phase II (Formulation and Schedule-finding).

COMBINATION_PRODUCT

MenB vaccine

MenB vaccine is administered intramuscularly as 2 doses in a 0,6-months schedule to participants in the Control Group in study Phase II (Formulation and Schedule-finding).

BIOLOGICAL

MenACWY vaccine

MenACWY vaccine is administered intramuscularly as 1 dose to participants in the Control Group in study Phase II (Formulation and Schedule-finding).

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-14
Primary Completion
2024-02-02
Completion
2024-02-02
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Finland
  • Poland
  • Sweden
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04886154 on ClinicalTrials.gov