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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Infections, Meningococcal

Treatments: Biological: MenABCWY; Other: Saline Placebo; Biological: Bexsero; Biological: Havrix

Study type: Interventional

Funder types: Industry

Identifiers

NCT02212457

205215

2013-002451-15 (EudraCT Number)

V102_15 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,063 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,063 participants in 6 patient groups

rMenB_0_2 Group

Experimental group

Description:

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.

Treatment:

Other: Saline Placebo

Biological: Havrix

Biological: Bexsero

ABCWY_ 0_2 Group

Experimental group

Description:

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.

Treatment:

Other: Saline Placebo

Biological: Havrix

Biological: MenABCWY

ABCWY_0_1 Group

Experimental group

Description:

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.

Treatment:

Other: Saline Placebo

Biological: Havrix

Biological: MenABCWY

ABCWY_0_6 Group

Experimental group

Description:

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.

Treatment:

Other: Saline Placebo

Biological: Havrix

Biological: MenABCWY

ABCWY_0_11 Group

Experimental group

Description:

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.

Treatment:

Other: Saline Placebo

Biological: Havrix

Biological: MenABCWY

ABCWY_0_2_6 Group

Experimental group

Description:

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.

Treatment:

Biological: Havrix

Biological: MenABCWY