NCT02946385 - Study to Assess the Immunological Long-term Persistence of Antibodies (Abs) 2 Years After GlaxoSmithKline (GSK) Meningococcal ABCWY Vaccination in the V102_15 (NCT02212457) and Response to a Booster in Adolescents | Biotech Hunter

Enrollment

604

Participants

Timeline

Start Date

November 15, 2016

Primary Completion Date

February 13, 2018

Study Completion Date

February 13, 2018

Conditions

Infections, Meningococcal

Interventions

BIOLOGICAL

Meningococcal ABCWY Vaccine

Intramuscular injection of one booster dose at Day 1 to follow-on subjects in the ABCWY\_ 0\_2 Group, ABCWY\_ 0\_2\_6 Group and ABCWY\_ 0\_6 Group, primed with 2 or 3 doses of the study vaccine and 2 doses at Days 1 and 61 to naïve subjects in the ABCWY naïve group.

BIOLOGICAL

Meningococcal B Recombinant vaccine

Intramuscular injection of one booster dose of the rMenB+OMV vaccine to subjects in the B\_0\_2 group, primed with 2 doses of the vaccine and intramuscular injection of 2 doses at Days 1 and 61 in the deltoid area of the non-dominant arm to naïve subjects in the rMenB+OMV Naïve group.

Trial Locations (17)

20520

GSK Investigational Site, Turku

28100

GSK Investigational Site, Pori

33100

GSK Investigational Site, Tampere

60100

GSK Investigational Site, Seinäjoki

67100

GSK Investigational Site, Kokkola

90220

GSK Investigational Site, Oulu

02230

GSK Investigational Site, Espoo

00100

GSK Investigational Site, Helsinki

00930

GSK Investigational Site, Helsinki

04400

GSK Investigational Site, Järvenpää

85-796

GSK Investigational Site, Bydgoszcz

39-200

GSK Investigational Site, Dębica

80 542

GSK Investigational Site, Gdansk

80-546

GSK Investigational Site, Gdansk

91 347

GSK Investigational Site, Lodz

41-103

GSK Investigational Site, Siemianowice Śląskie

50-368

GSK Investigational Site, Wroclaw