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

NCT05087056 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2026-04-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-18
Primary Completion
2027-03-10
Completion
2027-03-10
FDA Drug
Yes

Countries

  • United States

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 NCT05087056 on ClinicalTrials.gov