NCT05087056

Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents

A Phase IIb, Randomized, Observer-Blind Study to Describe the Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 11 Years – 14 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, tolerability, and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY) vaccine (GSK3536819A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups.

Conditions

• Meningitis, Meningococcal

Interventions

Type	Name	Description
COMBINATION_PRODUCT	MenABCWY vaccine	Two doses of the MenABCWY vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, on a 0-, 24-month schedule in the ABCWY-24 Group, and a 0-, 48-month schedule in the ABCWY-48 Group.
COMBINATION_PRODUCT	Placebo	Single dose of Placebo (saline solution in pre-filled syringe), administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1441 in the ABCWY-24 Group, and at Day 721 in the ABCWY-48 Group.

Timeline

• Start date: 2021-11-18
• Primary completion: 2027-03-10
• Completion: 2027-03-10
• First posted: 2021-10-21
• Last updated: 2026-04-13

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study