NCT02446743

Combined Study - Phase 3b MenB Long Term Persistence in Adolescents

A Phase 3b, Open Label, Controlled, Multi-Center, Extension Study to Assess the Persistence of Bactericidal Activity at 4 to 7.5 Years After Two Dose Primary Series of GlaxoSmithKline Biologicals Meningococcal B Recombinant Vaccine and the Response to a Third Dose in Adolescents and Young Adult Subjects Who Previously Participated in Parent Studies V72_41 (NCT01423084) and V72P10 (NCT00661713), Compared to Naïve Healthy Controls

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 531 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 15 Years – 24 Years
• Healthy volunteers: Accepted

Summary

The purpose/aim of this study is to assess 1) the long-term persistence (4 to 7.5 years after the last dose) of bactericidal activity following primary vaccination with rMenB+OMV NZ in adolescents \[who previously participated in parent studies V72\_41 (NCT0142384) and V72P10 (NCT00661713)\] and 2) the kinetics of immune response following booster vaccination with rMenB+OMV NZ

Detailed description

After all subjects (Groups A and B) from Canada and Australia have completed the study, an interim analysis for the primary and secondary immunogenicity objectives will be performed. Follow on subjects (Group A) from parent study V72\_41 (NCT0142384) will be analyzed for i) antibody persistence at approximately 4 years following a 2 dose primary series and ii) the immune response at 3, 7 and 30 days after a third dose (booster) of rMenB+OMV NZ. Canadian and Australian vaccine naïve subjects (Group B) will be analyzed for the immune response at 30 days after the first dose, and 3, 7 and 30 days after the second dose of rMenB+OMV NZ. Subjects in Group B (naïve subjects) will be randomized into two different blood draw schedules according to a 1:1 ratio.

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	rMenB+OMV NZ (Meningococcal (Group B) multi component recombinant adsorbed vaccine)	One dose of the vaccine administered intramuscularly in the deltoid area of the non-dominant arm.

Timeline

• Start date: 2015-11-17
• Primary completion: 2016-09-23
• Completion: 2016-09-23
• First posted: 2015-05-18
• Last updated: 2018-11-08
• Results posted: 2017-12-13

Locations

12 sites across 3 countries: Australia, Canada, Chile

Regulatory

• FDA-regulated drug study