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ACTIVE NOT RECRUITING
NCT05087056
PHASE2

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

11 Years - 14 Years

Study Type

INTERVENTIONAL

Enrollment

312

Start Date

2021-11-18

Completion Date

2027-03-10

Last Updated

2026-04-13

Healthy Volunteers

Yes

Interventions

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.

Locations (6)

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Ventura, California, United States

GSK Investigational Site

Macon, Georgia, United States

GSK Investigational Site

Valparaiso, Indiana, United States

GSK Investigational Site

Missoula, Montana, United States

GSK Investigational Site

Charlotte, North Carolina, United States