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

NCT04707391 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1250

Last updated 2024-07-03

Study results available
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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

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-25
Primary Completion
2023-05-03
Completion
2023-09-29
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Canada

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 NCT04707391 on ClinicalTrials.gov