At a glance
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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
In Brief
A Phase 2 clinical trial evaluating Meningococcal ABCWY Vaccine and Meningococcal B Recombinant vaccine for Infections, Meningococcal. Completed, enrolled 604 participants across 17 sites in 2 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
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.
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.