Pneumonia vaccine! Mercado 15 price pneumococcal conjugate vaccine V114 two adult Phase III clinical studies were successful!
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Last Update: 2020-07-20
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Source: Internet
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Author: User
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, June 23, 2020 //BiovalleyBIOON/-- Merck and Co recently announced the results of two Phase III clinical studies evaluating the safety, tolerance, and immunogenicity of the 15-valent pneumococcal-combined vaccine V114, showing that V114 met safety and immunogenicity goalsPNEU-WAY (W114-08) study in adults 18 years and older infected with HIV, the results showed that V114 produced an immune response to all 15 serotypes in the vaccine, including serotype 22F and 33FThe PNEU-FLU (V114-021) study was conducted in healthy adults 50 years and older and showed that V114 was administered in conjunction with theinfluenza vaccineThe results of these two studies, as well as the V110-029 study on Pneumococcal vaccine Pneumococcal ®23 in healthy adults aged 50 and over, were recently presented in the online digital library of the International Symposium on Pneumococcal and Pneumococcal Disease (ISPPD)"The greater risk of pneumococcal disease in certain populations reinforces the importance of new interventions to address their specific needs," said DrLuwy Musey, Executive Director of Vaccine Clinical Research at the's Mercado Research LaboratoryThe results of the first two Phase III studies from V114 are encouraging and we look forward to sharing additional data from our ongoing clinical development projects in the future, including our key study to assess V114 immunogenicity and the vaccine's potential to prevent serotypes that are most likely to cause invasive diseases"
images from: firstcry.com
V114 is a 15-valent pneumococcal combination vaccine developed by Mercado, currently in Phase III clinical development for the prevention of pneumococcal disease in adults and childrenV114 is made up of pneumococcal polysaccharides from 15 serotypes combined with crm197carriersproteins, including 22F and 33F serotypes, which are usually associated with invasive pneumococcal diseases worldwide but are not included in pneumococcal combination vaccines currently licensed for adults the V114 Phase III Clinical Development Project consists of 16 clinical trials , and studies the safety, tolerance and immunogenicity of V1114 in different populations, including healthy older people, healthy children, immunocompromised populations, and people with certain chronic diseases - PNEU-WAY: is a multi-centered, randomized, double-blind, positive comparative control phase III study conducted in people 18 years of age and older with HIV, with the aim of assessing the safety, tolerance and immunogenicity of Pmovneuax ®23 after 8 weeks of V114 vaccination In the study, a total of 302 subjects were randomly assigned to receive V114 (N-152) or the currently available 13-valent pneumococcal combination vaccine (PCV13) (N-150), and 2 groups were vaccinated with Pmovneuax ®23 after 8 weeks of vaccination results showed that the use of serotype-specific acidosis cell activity (OPA) geometric average titer (GMT) and immunoglobulin G (IgG) geometric mean concentration (GMC) to determine all 15 serotypes in the vaccine 30 days after vaccination, V114 reached the main immunogenicity target In the exploratory comparative analysis, V114 and PCV13 have a total of 13 serotypes of OPA-GMT and IgG-GMC in the two groups of general comparability In addition, the immune response of the two unique serotypes (22F and 33F) in the V114 group was higher than in the PCV13 group The security of the V114 is about the same as that of the PCV13 -PNEU-FLU:
is a multicenter, randomized, double-blind, placebo-controlled Phase III study designed to assess the safety, tolerance and immunogenicity of V114 when healthy adults aged 50 or over (N-1200) are simultaneously or non-simultaneously vaccinated against influenza
vaccine In the study, subjects who were randomly assigned to the simultaneous immunization group were given V114 and flu vaccine (QIV) on the first day and a placebo at the second visit about 30 days later Subjects who were randomly assigned to the non-simultaneous immune group were given placebo and QIV on the first day, and V114 at the second visit about 30 days later the study met two major immunogenic goals According to the serotype-specific OPA-GMT results 30 days after V114 vaccination, there was no significant difference between simultaneous vaccination and QIV vaccination and non-simultaneous vaccination In addition, qiV in combination with V114 is not inferior to QIV at the same time as V114, according to influenza virus-specific hemoglobin suppression (HAI) GMT 30 days after vaccination Based on cumulative safety data, the safety between the two vaccination groups was generally comparable the Company plans to continue to work with the U.S Food and Drug Administration (FDA) and other regulators around the world to submit a request for a v114 vaccine to market after obtaining additional data from Phase III In January 2019, the FDA awarded V114 Breakthrough Drug (BTD) to prevent invasive pneumococcal disease (IPD) caused by vaccine serotype in infants and adolescents between 6 weeks and 18 years of age (BioValleyBioon.com) original origins: Merck Announcs That V114, Its Bureau 15-Valent Pneumococcal Conjugate Vaccine, Met Safety and Immunogencity Objectives in Initial Phase 3 In Sadult S .
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