# GSK provides positive pivotal phase III data for MenABCWY vaccine

- Link: https://www.directorstalkinterviews.com/gsk-provides-positive-pivotal-phase-iii-data-for-menabcwy-vaccine/4121109965
- Published: 2023-03-14T07:42:41+00:00
- Author: Amilia Stone

**[GSK plc](https://www.directorstalkinterviews.com/ftse-company/glaxosmithkline-plc/gsk.l)**(
LON/NYSE: GSK) has announced positive headline results from the phase III trial (
NCT04502693) evaluating the safety, tolerability, and immunogenicity of its MenABCWY
combination vaccine candidate, administered as two doses given six months apart 
in healthy individuals aged 10-25 years. GSK’s MenABCWY vaccine candidate combines
the antigenic components of its licensed meningococcal vaccines, _Bexsero_ (MenB)
and _Menveo_ (MenACWY)_._ All primary endpoints were met, including the non-inferiority
of the vaccine candidate for all five _Neisseria meningitides_ serogroups (A, B,
C, W, and Y) compared to licensed meningococcal vaccines _Bexsero_ and _Menveo_ 
in terms of an immune response. In addition, the vaccine candidate was well tolerated,
with a safety profile consistent with _Bexsero_ and _Menveo_.

·   MenABCWY combination vaccine candidate met all 11 primary endpoints of the pivotal
phase III clinical trial and was well tolerated with a safety profile consistent
with _Bexsero_ and _Menveo_

·   The primary endpoint data demonstrated statistical non-inferiority compared 
to _Bexsero_ and _Menveo_ in individuals 10-25 years old, with the 5-in-1 vaccine
candidate eliciting a clinically meaningful immune response

·   If approved, this 5-in-1 vaccine candidate could provide the broadest meningococcal
serogroup coverage and could lead to a simplified immunisation schedule

Invasive meningococcal disease (IMD), a major cause of meningitis and septicaemia,
is an uncommon but serious illness that can cause life-threatening complications
or even death, typically amongst previously healthy children and adolescents.^(1)
Among those contracting meningococcal diseases, one in ten will die, sometimes in
as little as 24 hours, despite treatment.^(2) One-in-five survivors suffers long-
term consequences, such as brain damage, amputations, hearing loss and nervous system
problems.^(1)

Five _Neisseria meningitides_ serogroups (A, B, C, W, and Y) account for nearly 
all IMD cases in most of the world.^(3) As yet, no licensed combination vaccine 
offers protection against these serogroups in a single vaccine. Currently, in the
US, two separate vaccines needing four injections are required to protect against
all five serogroups. This immunisation regimen, coupled with low awareness of the
disease, can lead to sub-optimal immunisation coverage rates, particularly for MenB,
with an estimated coverage of only approximately 31% of adolescents in the US.^(
4)

> **Tony Wood, Chief Scientific Officer at GSK, said**: “These statistically significant
> phase III data are a very encouraging step toward reducing the incidence of meningococcal
> disease. In the US, routine use of a 5-in-1 meningococcal vaccine with a two-dose
> regimen in adolescents at 16 to 18 years of age, just before this disease’s incidence
> peak, could drive significant public health impact. In addition, our 5-in-1 meningococcal
> vaccine candidate builds on our global leadership in meningococcal vaccines and
> commitment to innovation.”

GSK is working closely with regulators to review the full phase III data set, including
the supplemental Biologics License Application for _Bexsero._ This clinical trial
was both the confirmatory trial for _Bexsero_ and the phase III trial for MenABCWY.
Detailed results from this phase III trial will be presented in a peer-reviewed 
publication and at upcoming scientific meetings.

_1 ECDC, Factsheet about meningococcal diseases. Accessed March 2023._

_2. Bing Wang et al., “Case fatality rates of invasive meningococcal disease by 
serogroup and age: A systematic review and meta-analysis”, in Vaccine, Volume 37,
Issue 21, 9 May 2019, Pages 2768-2782. Accessed March 2023._

_3 CDC. Meningococcal Disease Causes and How It Spreads | CDC. Accessed March 2023._

_4 Pingali C, Yankey D, Elam-Evans LD, et al. National Vaccination Coverage Among
Adolescents Aged 13-17 Years – National Immunization Survey-Teen, United States,
2021. MMWR Morb Mortal Wkly Rep 2022; 71:1101-1108._

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