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 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

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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15

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

WHAT IS KNOWN AND OBJECTIVE:

Patient 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.

METHODS:

Five 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 DISCUSSION:

The 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 CONCLUSION:

Pharmaceutical 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.

01 Mar 2015·Journal of pharmaceutical and biomedical analysisQ3 · MEDICINE

Determining trace amounts and the origin of formaldehyde impurity in Neisseria meningitidis A/C/Y/W-135-DT conjugate vaccine formulated in isotonic aqueous 1× PBS by improved C18-UPLC method

Q3 · MEDICINE

Article

Author: Gudlavalleti, Seshu K ; Harder, Jeffery D ; Reddy, Jeeri R ; Tran, Nhi N ; Crawford, Erika N ; Orten, Dana J

The ability to accurately measure and report trace amounts of residual formaldehyde impurity in a vaccine product is not only critical in the product release but also a regulatory requirement. In many bacterial or viral vaccine manufacturing procedures, formaldehyde is used either at a live culture inactivation step or at a protein de-toxification step or at both. Reported here is a validated and improved C18-UPLC method (developed based on previously published C-8 HPLC method) to determine the traces of formaldehyde process impurity in a liquid form Neisseria meningitidis A/C/Y/W-135-DT conjugate vaccine formulated in isotonic aqueous 1× PBS. UPLC C-18 column and the conditions described distinctly resolved the 2,4-DNPH-HCHO adduct from the un-reacted 2,4-DNPH as detected by TUV detector at 360 nm. This method was shown to be compatible with PBS formulation and extremely sensitive (with a quantitation limit of 0.05 ppm) and aided to determine formaldehyde contamination sources by evaluating the in-process materials as a track-down analysis. Final nanogram levels of formaldehyde in the formulated single dose vialed vaccine mainly originated from the diphtheria toxoid carrier protein used in the production of the conjugate vaccine, whereas relative contribution from polysaccharide API was minimal.

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	US	Sanofi Pasteur, Inc.	09 Dec 1999

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chickenpox	Phase 3	US	Sanofi Pasteur	01 Dec 2006
Chickenpox	Phase 3	PR	Sanofi Pasteur	01 Dec 2006
Measles	Phase 3	US	Sanofi Pasteur	01 Dec 2006
Measles	Phase 3	PR	Sanofi Pasteur	01 Dec 2006
Meningitis, Meningococcal	Phase 3	US	Sanofi Pasteur	01 Dec 2006
Meningitis, Meningococcal	Phase 3	PR	Sanofi Pasteur	01 Dec 2006
Mumps	Phase 3	US	Sanofi Pasteur	01 Dec 2006
Mumps	Phase 3	PR	Sanofi Pasteur	01 Dec 2006
Rubella	Phase 3	US	Sanofi Pasteur	01 Dec 2006
Rubella	Phase 3	PR	Sanofi Pasteur	01 Dec 2006

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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)	ygnchlonft(oilrqdpnpo) = yxdpjrqeso qpzjksvbwh (vtwzrhxjdm, eqxdmzcmoi - zftsupobhw) View more	-	09 Jun 2020
				Y Conjugate vaccine+Meningococcal polysaccharide groups A, C, W-135 (Group 2 (Meningococcal Vaccine-Naive): Nimenrix®)	ygnchlonft(oilrqdpnpo) = byluknjgtj qpzjksvbwh (vtwzrhxjdm, urogswmduy - djaazyvahl) View more
NCT00483574 (CTgov)	Phase 3	Rubella \| Mumps \| Measles ... View more	1,378	Measles-mumps-rubella-varicella vaccine+Routine paediatric vaccine - Pneumococcal conjugate (PCV)+Routine paediatric vaccine - Hepatitis A	kanhvtggbd(uztrpdlbme) = ottfzxknqo wlhcbccdnk (ctqtclamsv, humxmsopwv - mkntbevkem) View more	-	06 Jul 2011
NCT00422292 (CTgov)	Phase 3	Rubella \| Mumps \| Measles ... View more	1,664	Menactra (Group 1: Menactra® at 9 and 12 Months)	ywhlzatoch(rtqkojrehi) = arbyrolmjb iwxytgeodc (egwbxsnxde, afspjczmru - ttngckijno) View more	-	02 Jun 2011
				MMRV+Menactra (Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months)	okxyvqqiuy(uovxkkxbdk) = gvmunxtowq ckvnwjyife (frynevvbqs, mzhuslczfq - nrwadzzczc) View more
NCT00772070 (CTgov)	Phase 2	Meningitis \| Meningococcal Infections	173	A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)	hixdncmzqy(vlimhupuox) = kgyvvzlktf qfwjcpcrdd (exawcpijnz, ewasuahnbx - zeokxtiqmy) View more	-	14 May 2009
NCT00850603 (CTgov)	Phase 4	Meningitis \| Meningococcal Infections	170	Menomune (0.5 mL Subcutaneous Menomune®)	iogdkhodpo(boogepaltl) = pemlggltpf qeuivcepxl (mtdxtpamop, xmsgfebmyu - ujparxxhsv) View more	-	30 Apr 2009
				Menomune (0.1 mL Subcutaneous Menomune®)	iogdkhodpo(boogepaltl) = lunyjfhmab qeuivcepxl (mtdxtpamop, wmtyckylnh - tkrsiocahy) View more
NCT00771849 (CTgov)	Phase 2	Meningitis \| Meningococcal Infections	103	Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra® Vaccine Group)	ekjaridhaf(wlifqgqojz) = pvlgnyfwny brqwxxrodl (hpaixpmigm, qnuapwfrwy - zabwsrqmdd) View more	-	24 Apr 2009
				Haemophilus Influenzae Type b (Hib) vaccine (Hiberix® Vaccine Group)	ekjaridhaf(wlifqgqojz) = malrtvzltj brqwxxrodl (hpaixpmigm, usdfncvwzs - iewawtxuyy) View more