NCT04707391

Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine

A Phase IIIB, Randomized, Controlled, Observer-blind Study to Evaluate Safety and Immunogenicity of GSK's Meningococcal ABCWY Vaccine When Administered in Healthy Adolescents and Adults, Previously Primed With Meningococcal ACWY Vaccine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,250 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 15 Years – 25 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to assess immunogenicity and safety of MenABCWY vaccine in healthy adolescents and adults aged 15 to 25 years previously vaccinated with MenACWY vaccine.

Conditions

• Meningitis, Meningococcal

Interventions

Type	Name	Description
COMBINATION_PRODUCT	MenABCWY vaccine	2 doses of MenABCWY vaccine administered intramuscularly on Day 1 and Day 181 to participants in ABCWY group.
COMBINATION_PRODUCT	Placebo	1 dose of placebo administered intramuscularly on Day 211 to participants in ABCWY group
BIOLOGICAL	MenACWY vaccine	1 dose of MenACWY vaccine administered intramuscularly on Day 1 to participants in ACWY group
COMBINATION_PRODUCT	MenB vaccine	2 doses of MenB vaccine administered intramuscularly on Day 181 and Day 211 to participants in ACWY group. MenB vaccine is a non-investigational medical product (NIMP) in this study and is administered only in compliance with standard of care.

Timeline

• Start date: 2021-01-25
• Primary completion: 2023-05-03
• Completion: 2023-09-29
• First posted: 2021-01-13
• Last updated: 2024-07-03
• Results posted: 2024-07-03

Locations

69 sites across 4 countries: United States, Argentina, Australia, Canada

Regulatory

• FDA-regulated drug study