Infections, Meningococcal Clinical Trial
Official title:
A Phase 2b Open-Label Multi-Center Study Assessing the Immunological Persistence of Antibodies at Approximately 2 Years After the Last Meningococcal Vaccination in Study V102_15 (NCT02212457) and the Response to a Booster Dose of GSK MenABCWY or Meningococcal Serogroup B Vaccines, in Healthy Adolescents
The purpose of this study is to compare the persistence of 2 or 3 doses of the GSK MenABCWY vaccine, or 2 doses of GSK rMenB+OMV vaccine (Bexsero) administered to healthy adolescents at approximately 24 months after the last meningococcal vaccination in the parent study V102_15(NCT02212457), compared with baseline antibody levels in vaccine naïve subjects at similar age at enrolment.
Naive subjects will be randomized 1:1 to receive MenABCWY or rMenB+OMV at Day 1. No
randomization to treatment arm for follow-on subjects is required as vaccine groups remain
the same as in the parent study V102_15 (NCT02212457).
Response to a booster dose of MenABCWY vaccine will also be assessed in follow-on subjects
who received 2 or 3 doses of MenABCWY (at 0.2-, 0,.6- or 0,.2,.6-month schedules) in the
parent study, and will be compared with responses to a single dose of MenABCWY in naive
subjects (subjects who are meningococcal vaccine-naive and of similar age to subjects
enrolled from the parent study).
Response to a booster dose of GSK Meningococcal B Recombinant vaccine (rMenB+OMV) will be
assessed in subjects who received 2 doses of rMenB+OMV (at 0, 2-month schedule) in the parent
study, and will be compared with responses to a single dose of rMenB+OMV in naive subjects.
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