NCT03587207

Study to Assess Potential Immune Interference When GlaxoSmithKline (GSK) Biologicals' MenABCWY Vaccine is Administered to Healthy Subjects Aged 10-25 Years

Immunogenicity and Safety of Meningococcal MenABCWY Vaccine, and of rMenB+OMV NZ and MenACWY Administered Concomitantly in the Same Arm or in 2 Different Arms, or Alone

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 520 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 10 Years – 25 Years
• Healthy volunteers: Accepted

Summary

The purpose of the current study is to evaluate whether there is immune interference when MenABCWY \[consisting of MenACWY lyophilized component and rMenB+OMV NZ (Bexsero) liquid component\] is administered to healthy adolescents and adults following a 2-dose vaccination schedule with MenABCWY administered 2 months apart.

Conditions

• Meningitis, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	MenABCWY vaccine	Two doses administered intramuscularly in the deltoid region of the non-dominant arm.
BIOLOGICAL	rMenB+OMV NZ (Bexsero) vaccine	Two doses administered 2 months apart intramuscularly in the deltoid region of the non-dominant arm to subjects randomised to the rMenBOMV+ACWY\_S Group, rMenBOMV+ACWY\_D Group and rMenBOMV Group
BIOLOGICAL	MenACWY (Menveo) vaccine	Two doses administered intramuscularly in the deltoid region of the dominant/non-dominant arm to subjects randomised to the rMenBOMV+ACWY\_S Group and rMenBOMV+ACWY\_D Group and one dose administered intramuscularly in the deltoid region of the dominant/non-dominant arm to subjects randomised to the MenACWY Group

Timeline

• Start date: 2018-07-09
• Primary completion: 2018-12-19
• Completion: 2018-12-19
• First posted: 2018-07-16
• Last updated: 2020-02-12
• Results posted: 2020-01-02

Locations

1 site across 1 country: Czechia