NCT04886154

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

A Phase I/II, Randomised, Controlled Study to Assess the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine When Administered to Healthy Adults (Phase I) and to Healthy Adolescents and Adults (Phase II)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1,440 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 10 Years – 50 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2021-06-14
• Primary completion: 2024-02-02
• Completion: 2024-02-02
• First posted: 2021-05-13
• Last updated: 2025-05-31
• Results posted: 2025-02-26

Locations

53 sites across 8 countries: United States, Australia, Belgium, Brazil, Finland, Poland, Sweden, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study