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Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents

NCT02212457 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1063

Last updated 2019-06-27

Study results available
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Summary

The main purposes for conducting the study are firstly to assess immunological non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to healthy adolescents 10 to 18 years of age, to those of the licensed rMenB+OMV vaccine (Bexsero™) in terms of hSBA GMTs at one month after the second vaccination, secondly to give the flexibility for the national vaccination program by showing the safety and immunogenicity of MenABCWY administrated according to four different vaccination schedules and additionally to evaluate a potential benefit of the 3-dose vaccination series.

Conditions

  • Infections, Meningococcal

Interventions

BIOLOGICAL

Bexsero

Two doses administered intramuscularly into the deltoid area at Months 0 and 2 in rMenB\_0\_2 Group.

OTHER

Saline Placebo

One dose administered intramusculary in the deltoid muscle at Month 1 in ABCWY\_ 0\_2 Group and rMenB\_0\_2 Group, Month 2 in ABCWY\_0\_6 Group and ABCWY\_0\_11 Group and Month 6 in ABCWY\_0\_1 Group.

BIOLOGICAL

Havrix

Two doses administered in the deltoid muscle at Month 2 and 12 in ABCWY\_0\_1 Group, Month 1 and 12 in Group ABCWY\_0\_6 Group and ABCWY\_0\_2\_6 Group , Month 0 and 6 in ABCWY\_0\_11 Group and Month 6 and 12 in ABCWY\_ 0\_2 Group and rMenB\_0\_2 Group.

BIOLOGICAL

MenABCWY

Two to three doses administered in the deltoid muscle at Month 0 and 1 in ABCWY\_0\_1 Group, Month 0 and 6 in ABCWY\_0\_6 Group, Month 1 and 12 in ABCWY\_0\_11 Group, Month 0, 2 and 6 in ABCWY\_0\_2\_6 Group, Month 0 and 2 in ABCWY\_ 0\_2 Group and rMenB\_0\_2 Group.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-08-21
Primary Completion
2015-05-22
Completion
2016-03-03

Countries

  • United States
  • Finland
  • Poland

Study Locations

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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 NCT02212457 on ClinicalTrials.gov