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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

NCT ID: NCT02212457

Last Updated: 2019-06-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1063 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-21

Study Completion Date

2016-03-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Infections, Meningococcal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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rMenB_0_2 Group

Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.

Group Type EXPERIMENTAL

Bexsero

Intervention Type BIOLOGICAL

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

Saline Placebo

Intervention Type OTHER

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.

Havrix

Intervention Type BIOLOGICAL

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.

ABCWY_ 0_2 Group

Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.

Group Type EXPERIMENTAL

Saline Placebo

Intervention Type OTHER

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.

Havrix

Intervention Type BIOLOGICAL

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.

MenABCWY

Intervention Type BIOLOGICAL

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.

ABCWY_0_1 Group

Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.

Group Type EXPERIMENTAL

Saline Placebo

Intervention Type OTHER

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.

Havrix

Intervention Type BIOLOGICAL

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.

MenABCWY

Intervention Type BIOLOGICAL

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.

ABCWY_0_6 Group

Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.

Group Type EXPERIMENTAL

Saline Placebo

Intervention Type OTHER

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.

Havrix

Intervention Type BIOLOGICAL

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.

MenABCWY

Intervention Type BIOLOGICAL

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.

ABCWY_0_11 Group

Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.

Group Type EXPERIMENTAL

Saline Placebo

Intervention Type OTHER

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.

Havrix

Intervention Type BIOLOGICAL

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.

MenABCWY

Intervention Type BIOLOGICAL

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.

ABCWY_0_2_6 Group

Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.

Group Type EXPERIMENTAL

Havrix

Intervention Type BIOLOGICAL

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.

MenABCWY

Intervention Type BIOLOGICAL

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.

Interventions

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Bexsero

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

Intervention Type BIOLOGICAL

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.

Intervention Type OTHER

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.

Intervention Type 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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Adolecents from 10-18 yearsof age, generally in good health, and available for all study visits, and who/whose legally acceptable representative has given written informed consent at the time of enrollment.
2. Individuals of who the investigator believes can and will comply with the requirements of the protocol (e.g. use of an eDiary, return for follow-up visits, available for phone contacts).
3. Female subjects of childbearing potential must have a negative urine preganancy test.

Exclusion Criteria

1. Serious, acute, or chronic illness. Previous or suspected disease caused by N. meningitidis. Previous immunization with any menincococcal or Hepatitis A vaccines.
2. Exposure to individuals with clicically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characteriszation.
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Jonesboro, Arkansas, United States

Site Status

GSK Investigational Site

Hialeah, Florida, United States

Site Status

GSK Investigational Site

Melbourne, Florida, United States

Site Status

GSK Investigational Site

Augusta, Kansas, United States

Site Status

GSK Investigational Site

Niles, Michigan, United States

Site Status

GSK Investigational Site

Saint Paul, Minnesota, United States

Site Status

GSK Investigational Site

Bellevue, Nebraska, United States

Site Status

GSK Investigational Site

Omaha, Nebraska, United States

Site Status

GSK Investigational Site

Binghamton, New York, United States

Site Status

GSK Investigational Site

Cleveland, Ohio, United States

Site Status

GSK Investigational Site

Dayton, Ohio, United States

Site Status

GSK Investigational Site

Charleston, South Carolina, United States

Site Status

GSK Investigational Site

Mt. Pleasant, South Carolina, United States

Site Status

GSK Investigational Site

Espoo, , Finland

Site Status

GSK Investigational Site

Helsinki, , Finland

Site Status

GSK Investigational Site

Helsinki, , Finland

Site Status

GSK Investigational Site

Järvenpää, , Finland

Site Status

GSK Investigational Site

Kokkola, , Finland

Site Status

GSK Investigational Site

Oulu, , Finland

Site Status

GSK Investigational Site

Pori, , Finland

Site Status

GSK Investigational Site

Seinäjoki, , Finland

Site Status

GSK Investigational Site

Tampere, , Finland

Site Status

GSK Investigational Site

Turku, , Finland

Site Status

GSK Investigational Site

Vantaa, , Finland

Site Status

GSK Investigational Site

Dębica, , Poland

Site Status

GSK Investigational Site

Gdansk, , Poland

Site Status

GSK Investigational Site

Gdansk, , Poland

Site Status

GSK Investigational Site

Lodz, , Poland

Site Status

GSK Investigational Site

Osielsko, , Poland

Site Status

GSK Investigational Site

Siemianowice Śląskie, , Poland

Site Status

GSK Investigational Site

Warsaw, , Poland

Site Status

GSK Investigational Site

Wroclaw, , Poland

Site Status

Countries

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United States Finland Poland

Other Identifiers

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V102_15

Identifier Type: OTHER

Identifier Source: secondary_id

2013-002451-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

205215

Identifier Type: -

Identifier Source: org_study_id

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