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Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults

NCT04502693 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3657

Last updated 2024-03-05

Study results available
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Summary

The purpose of this study was to evaluate the effectiveness of 2 doses or 3 doses of GSK's licenced meningococcal group B Bexsero (rMenB+OMV NZ) vaccine and of 2 doses of GSK's investigational combined meningococcal (MenABCWY) vaccine (GSK3536819A) in healthy adolescents and young adults. The immunogenicity and safety were evaluated in the study.

Conditions

  • Infections, Meningococcal

Interventions

COMBINATION_PRODUCT

rMenB+OMV NZ vaccine

rMenB+OMV NZ vaccine was administered intramuscularly.

BIOLOGICAL

Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)

MenACWY vaccine was administered intramuscularly.

COMBINATION_PRODUCT

Placebo

Placebo was administered intramuscularly.

COMBINATION_PRODUCT

MenABCWY-1

Lot 1 of the MenABCWY vaccine was administered intramuscularly.

COMBINATION_PRODUCT

MenABCWY-2

Lot 2 of the MenABCWY vaccine was administered intramuscularly.

COMBINATION_PRODUCT

MenABCWY-3

Lot 3 of the MenABCWY vaccine was administered intramuscularly.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-08-14
Primary Completion
2022-09-13
Completion
2022-09-13
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • Estonia
  • Finland
  • Turkey (Türkiye)

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 NCT04502693 on ClinicalTrials.gov