NCT04502693

Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults

A Phase III, Randomized, Controlled, Observer-blind Study to Demonstrate Effectiveness, Immunogenicity and Safety of GSK's Meningococcal Group B and Combined ABCWY Vaccines When Administered to Healthy Adolescents and Young Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,657 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 10 Years – 25 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was 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 were evaluated in the study.

Detailed description

As per the feedback from the Center for Biologics Evaluation and Research (CBER), the scope of this post-marketing commitment study was 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 the MenB\_0\_2\_6, MenB\_0\_6 group, and MenACWY group, respectively, at day 211 were only as part of the standard care of treatment and to maintain blinding. These vaccination schedules were not considered for any endpoint evaluations.

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
COMBINATION_PRODUCT	rMenB+OMV NZ vaccine	rMenB+OMV NZ vaccine was administered intramuscularly.
BIOLOGICAL	Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)	MenACWY vaccine was administered intramuscularly.
COMBINATION_PRODUCT	Placebo	Placebo was administered intramuscularly.
COMBINATION_PRODUCT	MenABCWY-1	Lot 1 of the MenABCWY vaccine was administered intramuscularly.
COMBINATION_PRODUCT	MenABCWY-2	Lot 2 of the MenABCWY vaccine was administered intramuscularly.
COMBINATION_PRODUCT	MenABCWY-3	Lot 3 of the MenABCWY vaccine was administered intramuscularly.

Timeline

• Start date: 2020-08-14
• Primary completion: 2022-09-13
• Completion: 2022-09-13
• First posted: 2020-08-06
• Last updated: 2024-03-05
• Results posted: 2024-03-05

Locations

112 sites across 7 countries: United States, Australia, Canada, Czechia, Estonia, Finland, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study