Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness of 2 doses or 3 doses of GSK's
      licenced meningococcal group B Bexsero (rMenB+OMV NZ) vaccine and of 2 doses of GSK's
      investigational combined meningococcal (MenABCWY) vaccine (GSK3536819A) in healthy
      adolescents and young adults. The immunogenicity and safety will also be evaluated in the
      study.
    

Detailed description: 
      As per the feedback from Center for Biologics Evaluation and Research (CBER) the scope of
      this post-marketing commitment study has been extended to demonstrate the effectiveness,
      immunogenicity and safety of GSK's investigational combined meningococcal ABCWY vaccine along
      with the rMenB+OMV NZ vaccine. Note that the rMenB+OMV and MenACWY vaccines provided to
      MenB_0_2_6, MenB_0_6 group and MenACWY group respectively at day 211 are only as part of
      standard care of treatment and to maintain blinding. These vaccination schedules are not
      considered for any endpoint evaluations.
    

Intervention name(s): rMenB+OMV NZ vaccine; Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY); Placebo; MenABCWY-1; MenABCWY-2; MenABCWY-3
Intervention type(s): Combination Product; Biological; Combination Product; Combination Product; Combination Product; Combination Product
Intervention description(s): rMenB+OMV NZ vaccine is administered intramuscularly to the non-dominant arm as 3 doses in a 0,2,6-M schedule or as 2 doses in a 0,6-M schedule to participants in the MenB_0_2_6 Group, as 2 doses in a 0,6-M schedule to participants in the MenB_0_6 Group and as 2 doses at Day 181 and Day 211 to participants in the ACWY Group.; MenACWY vaccine is administered intramuscularly to the non-dominant arm as 1 dose at Day 211 to participants in the MenB_0_2_6 Group, as 1 dose at Day 61 to participants in the MenB_0_6 Group and as 1 dose at Day 1 to participants in the ACWY Group.; Placebo is administered intramuscularly to the non-dominant arm as 1 dose at Day 211 to participants in the MenB_0_6 Group, 2 doses at Day 61 and Day 211 to participants in the ABCWY groups and as 1 dose at Day 61 to participants in the ACWY Group.; Lot 1 of the MenABCWY vaccine is administered intramuscularly to the non-dominant arm as 2 doses at Day 1 and Day 181 to participants in the ABCWY-1 Group.; Lot 2 of the MenABCWY vaccine is administered intramuscularly to the non-dominant arm as 2 doses at Day 1 and Day 181 to participants in the ABCWY-2 Group.; Lot 3 of the MenABCWY vaccine is administered intramuscularly to the non-dominant arm as 2 doses at Day 1 and Day 181 to participants in the ABCWY-3 Group.
Other intervention name(s): Bexsero; Menveo; NaCl, saline solution
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Bexsero; Menveo; MenABCWY; Effectiveness; Invasive meningococcal disease; Meningitis