At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Immunogenicity and Safety of GSK Meningococcal ABCWY Vaccine Administered at Different Schedules Compared to GSK Meningococcal Group B Vaccine, in Healthy Adolescents
In Brief
A Phase 2 clinical trial evaluating Bexsero, Saline Placebo, and 2 other interventions for Infections, Meningococcal. Completed, enrolled 1,063 participants across 32 sites in 3 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Two doses administered intramuscularly into the deltoid area at Months 0 and 2 in rMenB\_0\_2 Group.
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.
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.
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.