Last reviewed 2026-05-14 · How we verify

MencevaxACWY TM

GlaxoSmithKline · Phase 3 active Biologic

MencevaxACWY TM is a Meningococcal conjugate vaccine Biologic drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y.

MencevaxACWY is a meningococcal conjugate vaccine that stimulates the immune system to produce antibodies against serogroups A, C, W, and Y of Neisseria meningitidis.

MencevaxACWY is a meningococcal conjugate vaccine that stimulates the immune system to produce antibodies against serogroups A, C, W, and Y of Neisseria meningitidis. Used for Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y.

Likelihood of approval

62.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
Big-pharma sponsor +3.0pp
GlaxoSmithKline is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	MencevaxACWY TM
Sponsor	GlaxoSmithKline
Drug class	Meningococcal conjugate vaccine
Modality	Biologic
Therapeutic area	Immunology
Phase	Phase 3

Mechanism of action

The vaccine contains polysaccharide capsules from meningococcal serogroups A, C, W, and Y conjugated to a protein carrier (tetanus toxoid), which enhances immunogenicity and T-cell dependent immune responses. Upon administration, it triggers both humoral and cellular immunity, leading to the production of bactericidal antibodies that protect against invasive meningococcal disease caused by these four serogroups.

Approved indications

Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y

Common side effects

Injection site pain
Injection site erythema
Injection site swelling
Headache
Myalgia
Fatigue

Key clinical trials

Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

MencevaxACWY TM CI brief — competitive landscape report
MencevaxACWY TM updates RSS · CI watch RSS
GlaxoSmithKline portfolio CI

Frequently asked questions about MencevaxACWY TM

What is MencevaxACWY TM?

MencevaxACWY TM is a Meningococcal conjugate vaccine drug developed by GlaxoSmithKline, indicated for Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y.

How does MencevaxACWY TM work?

MencevaxACWY is a meningococcal conjugate vaccine that stimulates the immune system to produce antibodies against serogroups A, C, W, and Y of Neisseria meningitidis.

What is MencevaxACWY TM used for?

MencevaxACWY TM is indicated for Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y.

Who makes MencevaxACWY TM?

MencevaxACWY TM is developed by GlaxoSmithKline (see full GlaxoSmithKline pipeline at /company/gsk).

What drug class is MencevaxACWY TM in?

MencevaxACWY TM belongs to the Meningococcal conjugate vaccine class. See all Meningococcal conjugate vaccine drugs at /class/meningococcal-conjugate-vaccine.

What development phase is MencevaxACWY TM in?

MencevaxACWY TM is in Phase 3.

What are the side effects of MencevaxACWY TM?

Common side effects of MencevaxACWY TM include Injection site pain, Injection site erythema, Injection site swelling, Headache, Myalgia, Fatigue.

Drug class: All Meningococcal conjugate vaccine drugs
Manufacturer: GlaxoSmithKline — full pipeline
Therapeutic area: All drugs in Immunology
Indication: Drugs for Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing