Freeze-dried meningococcal vaccine: Total error assessment of a near-infrared method for water content determination.

Freeze-dried meningococcal vaccine: Total error assessment of a near-infrared method for water content determination. Talanta. 2020 May 01;211:120659 Authors: Zubak AM, Horvat A, Čavužić D, Fabijanić I Abstract Accuracy of reference values obtained by the reference method is essential to ensure the quality of a near-infrared (NIR) model. The purpose of this study was to assess the accuracy of a newly developed NIR analytical method for the determination of water content in a freeze-dried meningococcal vaccine by evaluating not only uncertainties associated with the calibration model and NIR measurement procedures but also systematic error arising from the reference Karl-Fischer method. An experimental design based on the standard addition method (SAM) in freeze-dried vaccines is proposed for total error assessment of the NIR analytical system. The accuracy profile showed that the NIR model successfully determined water content over the 1.0-6.7% range. The SAM enabled overall proportional error assessment, which yielded a slope of 1.01. The present study confirmed the suitability of the proposed NIR analytical method for the determination of water content in the freeze-dried meningococcal vaccine. Furthermore, assessment of the overall proportional error proved that the NIR analytical method could be used to accurately estimate differences in water content, therein surpassing the reference method as the method of choice for determining intra- or inter...
Source: Talanta - Category: Chemistry Authors: Tags: Talanta Source Type: research

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Source: Human Vaccines and Immunotherapeutics - Category: Allergy & Immunology Authors: Source Type: research
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Source: Human Vaccines and Immunotherapeutics - Category: Allergy & Immunology Authors: Source Type: research
Condition:   Infections, Meningococcal Interventions:   Biological: Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ);   Biological: Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid);   Drug: Placebo Sponsor:   GlaxoSmithKline Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Abstract BACKGROUND: MenACYW-TT is an investigational quadrivalent meningococcal conjugate vaccine intended for use in individuals ≥6 weeks of age. We evaluated the safety and immunogenicity of MenACYW-TT when compared to a licensed quadrivalent conjugate meningococcal vaccine (Menveo®; MCV4-CRM; GlaxoSmithKline, Italy), and when co-administered with tetanus, diphtheria, acellular pertussis (Tdap) and human papilloma virus (HPV4) vaccines in healthy meningococcal vaccine-naïve adolescents (10-17 years old) in the United States of America. METHODS: In this pivotal Phase II, open-labe...
Source: Vaccine - Category: Allergy & Immunology Authors: Tags: Vaccine Source Type: research
This study aimed to investigate the genetic diversity of recent invasive meningococci in Turkey with respect to multilocus sequence type (MLST) and also meningococcal serogroup B (MenB) vaccine antigens to enable assessment of potential MenB strain coverage using the genetic Meningococcal Antigen Typing System (gMATS). Fifty-four isolates, representing 37.5% of all pediatric (ages 0-18 years) invasive meningococcal disease cases in Turkey from January 2013 to December 2017, underwent genome sequence analysis. Thirty-six (66.7%) isolates were MenB, 10 (18.5%) were serogroup W (MenW), 4 (7.4%) were serogroup A (MenA), 3...
Source: Vaccine - Category: Allergy & Immunology Authors: Tags: Vaccine Source Type: research
Conclusions: Because virtually all cases of pneumococcal meningitis lead to either permanent neurologic sequelae or death, it would be well worth the effort to develop a new vaccine capable of preventing pneumococcal meningitis regardless of capsular type. Such a vaccine would need to protect against colonization with most, if not all, pneumococci.
Source: The Pediatric Infectious Disease Journal - Category: Infectious Diseases Tags: Commentary Source Type: research
Background: Invasive pneumococcal disease (IPD) causes life-threatening illnesses including meningitis and bloodstream infection. Here, we report the impact of 7- and 13-valent pneumococcal conjugate vaccines (PCV7/PCV13) after introduction into the Irish pediatric immunization schedule in 2008 and 2010, respectively, and the clinical details surrounding suspected PCV vaccine failures. Methods: Serotyping and antimicrobial susceptibility testing of all culture-confirmed cases referred from children 50% since the introduction of PCVs. The most significant decline PCV serotypes in children
Source: The Pediatric Infectious Disease Journal - Category: Infectious Diseases Tags: Vaccine Reports Source Type: research
CONCLUSION: This paper highlights clear issues with the immunisation of adult CI recipients. PMID: 32161418 [PubMed - in process]
Source: New Zealand Medical Journal - Category: General Medicine Tags: N Z Med J Source Type: research
Conclusion. This study shows that macrolide resistance among S. pneumoniae isolated in Tunisia is mainly related to target site modification. Our observations demonstrate a high degree of genetic diversity and capsular types among strains resistant to macrolides. PMID: 32159507 [PubMed - as supplied by publisher]
Source: Journal of Medical Microbiology - Category: Microbiology Authors: Tags: J Med Microbiol Source Type: research
ConclusionApplying these new Choosing Wisely® recommendations will increase patient safety and the value of health care.
Source: Infection - Category: Infectious Diseases Source Type: research
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