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-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious Diseases

Active Indication

Meningococcal Infections

Inactive Indication

ChickenpoxMeaslesMeningitis+ [3]

Originator Organization

Sanofi

Active Organization

Aventis Pasteur MSD SNC

Inactive Organization

Sanofi PasteurSanofi Pasteur, Inc.

Drug Highest PhaseApproved

First Approval Date

United States (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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8

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

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.

01 Mar 2013·Journal of Adolescent HealthQ2 · MEDICINE

Use of MenACWY-CRM in Adolescents in the United States

Q2 · MEDICINE

Review

Author: Steven Black ; Stan L. Block

Adolescents constitute a high-risk group for invasive meningococcal disease. MenACWY-CRM (Menveo, Novartis Vaccines, Cambridge, MA) is a quadrivalent meningococcal conjugate vaccine indicated to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135, and Y. It has been approved for use in persons age 2-55 years. The tolerability and immunogenicity of MenACWY-CRM in adolescents have been ascertained in phase 2 and 3 trials against MPSV4 (Menomune, sanofi pasteur, Swiftwater, PA), an unconjugated quadrivalent meningococcal vaccine, and MenACWY-D (Menactra, sanofi pasteur), another conjugated quadrivalent meningococcal vaccine. Clinical trials also have demonstrated that MenACWY-CRM is well tolerated and immunogenic when administered to adolescents concomitantly with the combined tetanus, diphtheria, and acellular pertussis vaccine (Boostrix, GlaxoSmithKline Biologicals, Rixensart, Belgium) and the quadrivalent human papillomavirus vaccine (Gardasil, Merck & Co., Inc., Whitehouse Station, NJ).

01 Oct 2010·BioDrugsQ3 · MEDICINE

Meningococcal Quadrivalent (Serogroups A, C, W135, and Y) Conjugate Vaccine (Menveo®)

Q3 · MEDICINE

Review

Author: Deeks, Emma D

Menveo is a quadrivalent meningococcal polysaccharide conjugate vaccine containing the four Neisseria meningitidis capsular polysaccharides, A, C, W135, and Y, each conjugated to the mutant diphtheria toxin, known as crossreactive material 197 (CRM(197)). Administration of a single dose of the Menveo vaccine elicited a strong immune response against all four vaccine serogroups in adolescents and adults in randomized, single- or multicenter, phase II or III trials. In adolescents, Menveo was generally more immunogenic against vaccine serogroups than the polysaccharide conjugate vaccine Menactra or the unconjugated polysaccharide vaccine Menomune, in terms of seroresponse and/or seroprotection rates and geometric mean titers (GMTs) 1 month post-vaccination in two phase II or III studies. In two phase III trials in adults aged 19-55 years, the immunogenicity of Menveo was generally noninferior or superior to that of Menactra against all four vaccine serogroups, with regard to seroresponse/seroprotection rates, and GMTs 1 month after vaccination. Moreover, an exploratory arm of one of these studies suggested Menveo was at least as immunogenic as Menomune in adults aged 56-65 years. Longer term, the immunogenicity of Menveo persisted for 12-22 months post-vaccination in the adolescent studies, with the vaccine generally remaining at least as immunogenic as Menactra or Menomune. Coadministration of Menveo with a combined tetanus, reduced diphtheria, and acellular pertussis (Tdap) vaccine or Tdap and human papillomavirus vaccines generally did not affect the immunogenicity of these vaccines in adolescents and young adults in two additional randomized, single- or multicenter, phase III studies. The tolerability profile of Menveo was generally similar to that of the comparator vaccines Menactra or Menomune in adults and adolescents, and few Menveo recipients experienced serious adverse events within 30 days or 6 months post-vaccination.

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

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Meningococcal Infections	Italy	Aventis Pasteur MSD SNC	17 Mar 2002

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chickenpox	Discovery	Puerto Rico	Sanofi Pasteur	01 Dec 2006
Chickenpox	Discovery	United States	Sanofi Pasteur	01 Dec 2006
Measles	Discovery	Puerto Rico	Sanofi Pasteur	01 Dec 2006
Measles	Discovery	United States	Sanofi Pasteur	01 Dec 2006
Meningitis, Meningococcal	Discovery	Puerto Rico	Sanofi Pasteur	01 Dec 2006
Meningitis, Meningococcal	Discovery	United States	Sanofi Pasteur	01 Dec 2006
Mumps	Discovery	United States	Sanofi Pasteur	01 Dec 2006
Mumps	Discovery	Puerto Rico	Sanofi Pasteur	01 Dec 2006
Meningococcal Infections	Discovery	United States	Sanofi Pasteur, Inc.	09 Dec 1999

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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)	ulehqxlpym(tjlhpgfqkw) = nopcdxbaey jryrwtkegb (ussxclmejt, umkpomukzz - jmgjuztuat) View more	-	09 Jun 2020
				Y Conjugate vaccine+Meningococcal polysaccharide groups A, C, W-135 (Group 2 (Meningococcal Vaccine-Naive): Nimenrix®)	ulehqxlpym(tjlhpgfqkw) = xpshjbrkzw jryrwtkegb (ussxclmejt, qtvwlcxleu - kpqojabbvv) View more
NCT01239043 (CTgov)	Phase 2	Meningitis, Meningococcal	139	Menomune®: A, C, Y, W 135 Meningococcal Polysaccharide (Menomune® Vaccine Group)	lltzrjdwxr(vhfmoeaqkh) = mxjxhfoglc uhwrcamqoi (sduhemjhnu, wbsoxwymju - oougisqoab) View more	-	19 Jun 2012
				Menactra®: Meningococcal (A, C, Y (Menactra® Vaccine Group)	lltzrjdwxr(vhfmoeaqkh) = yucelpehwb uhwrcamqoi (sduhemjhnu, heerctixbi - ncksnhnwmw) View more
NCT00850603 (CTgov)	Phase 4	Meningitis \| Meningococcal Infections	170	Menomune (0.5 mL Subcutaneous Menomune®)	cjwmogulxl(mlatgwwnxy) = laxurqmzyv gatjxjqsoq (uergzhgyzq, zgplnwundu - nvxteqxcep) View more	-	30 Apr 2009
				Menomune (0.1 mL Subcutaneous Menomune®)	cjwmogulxl(mlatgwwnxy) = mfyeqxiaiy gatjxjqsoq (uergzhgyzq, zparoztzvk - ytlvxfewue) View more