Meningococcal polysaccharide vaccine group Y

Overview

Meningococcal group Y polysaccharide is group-specific polysaccharide antigens extracted and purified from Neisseria meningitidis serogroup Y. N. meningitidis is a bacteria that causes endemic and epidemic diseases including meningitis and meningococcemia. It is subcutaneously administered as an active immunization against the invasive meningococcal disease caused by the serogroup Y.

Indication

No indication information available.

Associated Conditions

Invasive Meningococcal Infection caused by Neisseria meningitidis serogroup Y

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants	2024/10/17	NCT06647407	Phase 1	Recruiting	Sanofi Pasteur, a Sanofi Company
Study on Immunogenicity and Safety of a Meningococcal ACYW Conjugate Vaccine in Healthy Infants and Toddlers	2024/02/29	NCT06284915	Phase 3	Active, not recruiting	Sanofi Pasteur, a Sanofi Company
Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents	2023/11/13	NCT06128733	Phase 1	Active, not recruiting	Sanofi Pasteur, a Sanofi Company
Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy	2023/07/03	NCT05929651	Phase 4	Recruiting	Sanofi Pasteur, a Sanofi Company
A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months	2023/02/24	NCT05743881	Phase 1	Active, not recruiting	ModernaTX, Inc.
Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine	2021/10/26	NCT05093829	Phase 3	Completed	Emory University
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion (Ad26.RSV.Pre-F) Vaccine in RSV-Seronegative Toddlers 12 to 24 Months of Age	2018/07/31	NCT03606512	Phase 1	Completed	Janssen Vaccines & Prevention B.V.
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine When Co-administered With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe	2018/06/06	NCT03547271	Phase 3	Completed	Sanofi Pasteur, a Sanofi Company
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US	2018/05/25	NCT03537508	Phase 3	Completed	Sanofi Pasteur, a Sanofi Company

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
Menveo Powder and Solution for Solution for Injection	GSK Vaccines S.r.l. (MenCWY Liquid), GSK Vaccines GmbH (MenA Lyo)	SIN14083P	INJECTION, POWDER, FOR SOLUTION	5 microgram conjugated to 5.6-10 microgram	1/20/2012
Menactra®, solution for injection	Sanofi Pasteur Inc.	SIN13922P	INJECTION, SOLUTION	4 mcg/dose (0.5 ml)	2/24/2011
MENQUADFI SOLUTION FOR INJECTION	Sanofi Pasteur, Inc.	SIN16454P	INJECTION, SOLUTION	10 mcg/ 0.5 mL	3/29/2022

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
MENVEO Meningococcal (Groups A,C,W-135 and Y) Oligosaccharide CRM197 solution for injection vial	393321	GlaxoSmithKline Australia Pty Ltd	Medicine	A	9/26/2023
MENVEO meningococcal (Groups A, C, W-135 and Y) oligosaccharide CRM197 conjugate vaccine	192696	GlaxoSmithKline Australia Pty Ltd	Medicine	A	5/23/2012
NIMENRIX Meningococcal (Groups A, C, W-135, Y) Polysaccharide Tetanus Toxoid Conjugate Vaccine, injection vial and diluent syringe	199742	Pfizer Australia Pty Ltd	Medicine	A	8/29/2013
MenQuadfi meningococcal (Groups A,C,Y,W) polysaccharide tetanus toxoid conjugate vaccine, solution for injection, vial	325682	Sanofi-Aventis Australia Pty Ltd	Medicine	A	10/29/2020

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
MENOMUNE-A/C/Y/W-135	aventis pasteur limited	02161184	Powder For Solution - Subcutaneous	2.5 MG / KIT	8/13/1998
NIMENRIX	Pfizer Canada Ulc	02402904	Powder For Solution , Kit - Intramuscular	5 MCG / 0.5 ML	8/22/2013
MENOMUNE-A/C/Y/W-135	Sanofi Pasteur Limited	00588490	Powder For Solution - Subcutaneous	500 MCG / KIT	12/31/1983
MENOMUNE-A/C/Y/W-135	Sanofi Pasteur Limited	01959018	Powder For Solution , Kit - Subcutaneous	50 MCG / 0.5 ML	10/29/1993

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

FDA Expands MenQuadfi Meningococcal Vaccine Approval to Include Infants as Young as 6 Weeks

2 months ago

The FDA approved an expanded indication for Sanofi's MenQuadfi meningococcal vaccine to include children aged 6 weeks to 23 months, making it the only MenACWY vaccine with no upper age limit.

Phase III Trial Confirms Strong Immune Response to Two-Dose Meningococcal Vaccine Series in Adolescents

5 months ago

New phase III trial data demonstrates over 99% of adolescents achieved protective antibody levels against all four meningococcal serotypes after receiving a MenACWY-TT booster dose.

FDA Gears Up for Key Decisions on Vaccines and Novel Therapies in H1 2025

6 months ago

• The FDA is set to decide on Bavarian Nordic's CHIKV VLP vaccine for chikungunya, potentially the first VLP-based option in the U.S. • GSK's ABCWY vaccine, targeting multiple strains of Neisseria meningitidis, awaits FDA decision for primary care and pediatric use. • Innoviva Specialty Therapeutics' zoliflodacin, a novel antibiotic for gonorrhea, is under FDA review amid rising antimicrobial resistance. • Merck's clesrovimab, a monoclonal antibody for COVID-19, is being reviewed by the FDA for pediatric patients.

GSK's Penmenvy Approved by FDA for Meningococcal Disease Prevention in Adolescents and Young Adults

8 months ago

The FDA has approved GSK's Penmenvy vaccine for individuals aged 10-25, targeting five major serogroups of Neisseria meningitidis.

GSK's Single-Vial, Fully Liquid Menveo Receives Positive CHMP Opinion for Meningococcal Disease Prevention

10 months ago

The European Medicines Agency's CHMP has recommended GSK's single-vial, fully liquid Menveo for active immunization against invasive meningococcal disease (IMD).

Help Us Improve

Your feedback helps us provide better drug information and insights.

AI-Powered Research

Premium Access