NCT02212457 - Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents | Biotech Hunter

Enrollment

1,063

Participants

Timeline

Start Date

August 21, 2014

Primary Completion Date

May 22, 2015

Study Completion Date

March 3, 2016

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.

Trial Locations (32)

13901

GSK Investigational Site, Binghamton

20520

GSK Investigational Site, Turku

28100

GSK Investigational Site, Pori

29414

GSK Investigational Site, Charleston

29464

GSK Investigational Site, Mt. Pleasant

32934

GSK Investigational Site, Melbourne

33012

GSK Investigational Site, Hialeah

33100

GSK Investigational Site, Tampere

39200

GSK Investigational Site, Dębica

44122

GSK Investigational Site, Cleveland

45406

GSK Investigational Site, Dayton

49120

GSK Investigational Site, Niles

50368

GSK Investigational Site, Wroclaw

55108

GSK Investigational Site, Saint Paul

60100

GSK Investigational Site, Seinäjoki

67010

GSK Investigational Site, Augusta

67100

GSK Investigational Site, Kokkola

68005

GSK Investigational Site, Bellevue

68114

GSK Investigational Site, Omaha

72401

GSK Investigational Site, Jonesboro

86031

GSK Investigational Site, Osielsko

90200

GSK Investigational Site, Oulu

91347

GSK Investigational Site, Lodz

02230

GSK Investigational Site, Espoo

00100

GSK Investigational Site, Helsinki

00930

GSK Investigational Site, Helsinki

04400

GSK Investigational Site, Järvenpää

01300

GSK Investigational Site, Vantaa

80 542

GSK Investigational Site, Gdansk

80-546

GSK Investigational Site, Gdansk

41 103

GSK Investigational Site, Siemianowice Śląskie

01809

GSK Investigational Site, Warsaw