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

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.

Timeline

Start

2020-08-14

Primary completion

2022-09-13

Completion

2022-09-13

Outcome

Met primary endpoint

paper All primary objectives for MenABCWY were met. PMID 39647494 ↗

paper Non-inferiority of MenABCWY to 4CMenB was demonstrated by enc-hSBA assay PMID 39647494 ↗

paper Non-inferiority of two-dose MenABCWY to one-dose MenACWY-CRM was demonstrated by traditional hSBA assay PMID 39647494 ↗

release “In the phase III trial (NCT04502693), all primary endpoints were achieved for the MenABCWY vaccine candidate” gsk.com ↗

Publications

• Nolan T, Bhusal C, Beran J, Bloch M, Cetin BS, Dinleyici EC, Drazan D, Kokko S, Koski S, Laajalahti O, Langley JM, Ramet M, Richmond PC, Silas P, Tapiero B, Tiong F, Tipton M, Ukkonen B, Ulukol B, Lattanzi M, Trapani M, Willemsen A, Toneatto D; QUINTET study group. Breadth of immune response, immunogenicity, reactogenicity, and safety for a pentavalent meningococcal ABCWY vaccine in healthy adolescents and young adults: results from a phase 3, randomised, controlled observer-blinded trial. Lancet Infect Dis. 2025 May;25(5):560-573. doi: 10.1016/S1473-3099(24)00667-4. Epub 2024 Dec 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MenABCWY	Vaccine	—	Intramuscular
Subject	Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)	Vaccine	—	Intramuscular
Subject	rMenB+OMV NZ vaccine	Vaccine	—	Intramuscular

Indications