Delving into the Latest Updates on Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W-135 Combined(Sanofi) with Synapse

Overview

Basic Info

Drug Type

Combination vaccine, Prophylactic vaccine

Synonyms

Menomune-A/C/Y/W-135

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesNervous System Diseases

Active Indication-

Inactive Indication

MeningitisMeningococcal Infections

Originator Organization

Sanofi

Active Organization-

Inactive Organization

Sanofi PasteurSanofi Pasteur, Inc.

Drug Highest PhaseWithdrawn

First Approval Date

US (09 Dec 1999),

Meningococcal Infections

Regulation-

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The purpose of the study was to evaluate the immunogenicity and describe the safety of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed Meningococcal polysaccharide groups A, C, W-135 and Y (Nimenrix®) Conjugate vaccine in toddlers 12 to 23 months of age in the European Union (EU). The toddlers were either meningococcal vaccine naïve or had received monovalent meningococcal C (MenC) vaccination during infancy to evaluate any potential impact of the meningococcal vaccine background on the immunogenicity and safety profile of the investigational product.
Primary Objectives:
To demonstrate the non-inferiority of the antibody response to meningococcal serogroups A, C, Y, and W after a single dose of MenACYW Conjugate vaccine or Nimenrix® in toddlers who either were meningococcal vaccine naïve or had received monovalent MenC vaccination during infancy.
To demonstrate the non-inferiority of the antibody response to meningococcal serogroups A, C, Y, and W after a single dose of MenACYW Conjugate vaccine or Nimenrix® in meningococcal vaccine naïve toddlers.
Secondary Objectives:
To compare the antibody responses (geometric mean titers [GMTs]) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW Conjugate vaccine or Nimenrix® as measured by serum bactericidal assay using human complement (hSBA) in toddlers who either were meningococcal vaccine naïve or had received monovalent MenC vaccination during infancy.
To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW Conjugate vaccine or Nimenrix® as measured by hSBA in meningococcal vaccine naïve toddlers.
To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW Conjugate vaccine or Nimenrix® as measured by hSBA in toddlers who received monovalent MenC vaccination during infancy.

Start Date24 Feb 2017

Sponsor / Collaborator

Sanofi Pasteur

NCT01239043 / CompletedPhase 2

Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® Vaccine Approximately Three Years Following Initial Vaccination in Adults Who Participated in Trial MTA29

The purpose of this trial is to describe antibody persistence and response to re-vaccination with either Menactra® or Menomune® vaccine approximately three years following initial vaccination in adults who participated in trial MTA29 (NCT00874549).
Objectives:
To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination.
To evaluate persistence of serum bactericidal antibodies in subjects who received Menactra® or Menomune® vaccine approximately three years ago.
To evaluate the immune response to serogroups A, C, Y, and W-135 in subjects re-vaccinated with either Menactra® or Menomune® vaccine.

Start Date01 Nov 2010

Sponsor / Collaborator

Sanofi

NCT00862277 / CompletedNot Applicable

Evaluation of the Persistence of Bactericidal Antibodies in Adolescents and Adults Who Received a Single Dose of Menactra® Four to Eight Years Earlier

To evaluate the persistence of bactericidal antibodies in adolescents and adults who received one dose of Menactra® vaccine approximately four to eight years earlier

Start Date01 Dec 2008

Sponsor / Collaborator

Sanofi Pasteur

100 Clinical Results associated with Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W-135 Combined(Sanofi)

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100 Translational Medicine associated with Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W-135 Combined(Sanofi)

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100 Patents (Medical) associated with Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W-135 Combined(Sanofi)

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16

Literatures (Medical) associated with Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W-135 Combined(Sanofi)

01 Apr 2022·Infectious Diseases and TherapyQ3 · MEDICINE

A Decade of Fighting Invasive Meningococcal Disease: A Narrative Review of Clinical and Real-World Experience with the MenACWY-CRM Conjugate Vaccine

Q3 · MEDICINE

ReviewOA

Author: Ruiz Garcia, Yara ; Bekkat-Berkani, Rafik ; Soumahoro, Lamine ; Pellegrini, Michele ; Abitbol, Véronique

The quadrivalent A, C, W and Y meningococcal vaccine conjugated to nontoxic mutant of diphtheria toxin (MenACWY-CRM) has been licensed since 2010 for the prevention of invasive meningococcal disease (IMD), an uncommon but life-threatening condition. Here, we summarize the experience accrued with MenACWY-CRM during the first decade since its licensure, by providing an overview of clinical trials investigating the safety, immunogenicity and co-administration of MenACWY-CRM with other vaccines as well as presenting real-world evidence regarding the impact of MenACWY-CRM vaccination on carriage and IMD incidence. MenACWY-CRM has demonstrated an acceptable clinical safety profile across a wide range of age groups; no safety concerns have been reported in special populations, such as immunocompromised infants and toddlers, or pregnant women. MenACWY-CRM has also been proven to be immunogenic in various age groups and geographic settings, and a booster dose has been shown to elicit strong anamnestic responses in all studied populations, irrespective of the vaccine used for priming. With no clinically relevant vaccine interactions reported, MenACWY-CRM is being conveniently integrated into existing vaccination programs for various age and risk groups; this possibility of co-administration helps improving vaccine coverage and streamlining the healthcare process of fighting preventable infectious diseases. Vaccination of adolescents and adults has been proven to reduce nasopharyngeal carriage for serogroups C, W and Y, which is an important element in reducing transmission. Real-world evidence indicates that MenACWY-CRM can reduce IMD incidence even in high-exposure groups. When combined with vaccines against serogroup B meningococci, MenACWY-CRM can offer protection against five of the most common serogroups responsible for IMD, which is an important advantage in the continuously evolving landscape of meningococcal serogroup epidemiology.

01 Aug 2021·Journal of Clinical Pharmacy and TherapeuticsQ4 · MEDICINE

Improving meningococcal MenACWY and 4CMenB/meningococcal group B vaccine‐related health literacy in patients: Importance of readability of pharmaceutical Patient Leaflets

Q4 · MEDICINE

Article

Author: Brennan, Orlaith C. ; Millar, Beverley C. ; Moore, John E. ; Moore, Peter JA ; Nutt, Thomas W.

WHAT IS KNOWN AND OBJECTIVEPatient information leaflets (PILs) or Patient Leaflets (PLs) formally accompany dispensed medicines and are intended to provide the patient with information on how to use the medicine safely. To date, there have been no studies that have examined the readability of meningococcal vaccine patient-facing information, including information contained within the vaccine PIL. Given the role of pharmacists in presenting PILs to patients, it was, therefore, the aim of this study to quantitatively analyse the readability of Patient Leaflets, which accompany licensed meningococcal vaccines in the UK and US and to compare PILs to vaccine pharmaceutical manufacturers' summary of product characteristics (SPC), as well as other patient-facing vaccine-related information.METHODSFive sources of meningococcal vaccine information were examined for the licensed meningococcal vaccines in the UK (Bexsero, Menveo, Menitorix, Trumenba, Nimenrix & NeisVac-C) and in the United States (Bexsero, Menveo, Trumenba, Menactra, Menomune-A/C/Y/W-135, Menquadfi), including as follows: (i) SPC (Electronic Medicines Compendium, UK), (ii) Package Insert (FDA; USA), (iii) Patient Leaflet (Electronic Medicines Compendium, UK), (iv) Vaccine pharmaceutical websites and (v) government web resources. Readability was examined employing 10 readability metrics, including the Flesch Reading Ease and the Flesch-Kincaid Grade level.RESULTS AND DISCUSSIONThe information source with the greatest readability scores was the UK Patient Leaflet, which had a mean Flesch Reading Ease score of 58.1 and a mean Flesch-Kincaid Grade score of 7.3, followed by the US Department of Health & Human Services patient-facing website for vaccines (55.9 & 8, respectively), followed by the US Centers for Disease Control and Prevention Vaccine Information Statement (47.3 & 9.4, respectively). Pharmaceutical patient-facing websites for meningococcal vaccines had mean scores of 44.6 and 9.9, respectively. When compared with UK Patient Leaflets, pharmaceutical websites were statistically different with poorer readability with both Flesch Reading Ease and Flesch-Kincaid Grade Level indices (p = 0.02 & p = 0.04, respectively).WHAT IS NEW AND CONCLUSIONPharmaceutical meningococcal vaccine PILs were easily read and had statistically significant good readability scores in comparison with vaccine SPCs and US Package Inserts, pharmaceutical product websites and other government patient-facing meningococcal vaccine information. Preparation of patient-facing materials of a complex topic, such as describing meningococcal vaccines, is difficult to accomplish. Although there is a plurality of sources of information through websites and social media, PILs are one of the few sources that are provided directly to patients. This underpins the potential importance of PILs and the importance of their readability. Adoption of readability calculators and scrutiny of materials for their readability will help authors develop materials with improved understanding for vaccine recipients, potentially leading to improved health literacy and vaccine uptake. Renewed efforts should be sought to promote the information within the PIL, thereby maximizing the value of this resource with vaccine recipients, their carers and family.

05 May 2015·Analytical ChemistryQ1 · CHEMISTRY

Determination of Meningococcal Serogroups in Formulated Monovalent and Multivalent Polysaccharide and Polysaccharide-Conjugate Vaccines

Q1 · CHEMISTRY

Article

Author: Kunkel, Jeremy P. ; Cook, Matthew C.

Comment on "Quantification of each Serogroup Polysaccharide of Neisseria meningitidis in A/C/Y/W-135-DT Conjugate Vaccine by High-Performance Anion-Exchange Chromatog.-Pulsed Amperometric Detection Anal." Gudlavalleti, S.K.; Crawford, E.N.; Harder, J.D.; Reddy J.R.Anal.Chem. 2014, 86, 5383-5390.

100 Deals associated with Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W-135 Combined(Sanofi)

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External Link

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Meningitis	Discovery	US	Sanofi Pasteur	01 Mar 2003

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02955797 (CTgov)	Phase 3	Meningitis, Meningococcal	918	W) Tetanus Toxoid Conjugate Vaccine (Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine)	fvplkcqjok(ezavtyghvg) = vpzapxrsma huodfjhcgn (ugvznixuxp, ufbkxbdpkh - vybdkdlokc) View more	-	09 Jun 2020
				Y Conjugate vaccine+Meningococcal polysaccharide groups A, C, W-135 (Group 2 (Meningococcal Vaccine-Naive): Nimenrix®)	fvplkcqjok(ezavtyghvg) = lunnugzpjy huodfjhcgn (ugvznixuxp, sbyanehlkc - nuzbwebyfu) View more
Pubmed \| Drugs Aging	Not Applicable	-	400	Quadrivalent Meningococcal Serogroups A, C, W-135 and Y Tetanus Toxoid Conjugate Vaccine (MenACWY-TT) (MenACWY-TT)	ozqyisbiee(jbcwlfjxia) = rstnhejnfm caukvdjlfk (rxuirvqdhl ) View more	-	01 May 2013
				Quadrivalent Meningococcal Serogroups A, C, W-135 and Y Tetanus Toxoid Conjugate Vaccine (MenACWY-TT) (MenPS)	lnlpiajmif(zpjjjfzqar) = jowtqrlllx eeljhbciln (juldunmizg ) View more
NCT01239043 (CTgov)	Phase 2	Meningitis, Meningococcal	139	Menomune®: A, C, Y, W 135 Meningococcal Polysaccharide (Menomune® Vaccine Group)	vanaczzutq(xazjiqxpyk) = otjfyufrow qhosrhfprm (rhlwnvhlbz, rdspxrfxzg - zjzndgqyfr) View more	-	19 Jun 2012
				Menactra®: Meningococcal (A, C, Y (Menactra® Vaccine Group)	vanaczzutq(xazjiqxpyk) = tellojplnw qhosrhfprm (rhlwnvhlbz, brmayijxny - rwvrdhowhk) View more
NCT00850603 (CTgov)	Phase 4	Meningitis \| Meningococcal Infections	170	Menomune (0.5 mL Subcutaneous Menomune®)	ntiutishyu(crgtlbbhot) = xedtwqfjnw hhkfrlcicq (pnwkrjkjst, swowhxdaoh - yftijybmqe) View more	-	30 Apr 2009
				Menomune (0.1 mL Subcutaneous Menomune®)	ntiutishyu(crgtlbbhot) = otvyecpebk hhkfrlcicq (pnwkrjkjst, vpztpfuaxo - rldfjkihja) View more