15-price pneumonia vaccine! Mercedon V114 two Adult III studies were successful: submit a listing application at the end of the year!

September 10, 2020 // -- Merck and Co recently announced that two Phase III clinical studies evaluating the safety, toerability and immunogenicity of the Pneumococcal-binding vaccine V114 (15 price) in the study have achieved major immunogenicity targets.
June this year, two other Adult III studies of V114 also met safety and immunogenicity targets.
-PNEU-AGE (V114-019) study: Conducted in healthy adults 50 years of age and older, the results showed that: (1) V114 was not inferior to PCV13 in terms of 13 serotypes common to 2 vaccines compared to the listed 13-price pneumococcal binding vaccine (PCV13).
(2) V114 is highly effective in terms of the additional 2 serotypes 22F and 33F (not included in PCV13) contained in V114.
these results are based on antibody conditioning of phagocytic activity (opsonophagocytic activityy, OPA) reaction, OPA reaction can be used to determine vaccine-induced functional antibodies.
addition, the study also achieved key secondary immunogenic targets, confirming that V114 is effective in serotype 3 (the leading cause of global invasive pneumococcal disease) compared to PCV13.
-PNEU-TRUE (V114-020) study, conducted in healthy adults 50 years and older, showed that V114 met the primary immunogenicity target, confirming that three different batches of V114 had the same immune response in all 15 serotypes.
in both studies, V114 was generally well-to-do, as safe as PCV13 and consistent with V114 observed in previously reported studies.
In June this year, two other adult Phase III studies of V114 also met safety and immunogenicity goals: (1) the PNEU-WAY (W114-08) study was conducted in adults 18 years of age and older infected with HIV, and the results showed that V114 produced immune responses to all 15 serotypes in the vaccine, including serotypes 22F and 33F.
(2) PNEU-FLU (V114-021) study was conducted in healthy adults 50 years of age and older, and showed that V114 could be vaccinated in the same time as the four-price flu vaccine.
findings, as well as phase 3 data from the Mercedon Clinical Project, will be presented at future scientific conferences and will serve as a basis for submitting applications for regulatory clearances worldwide.
the company plans to file v114 regulatory filings with the U.S. Food and Drug Administration (FDA) by the end of the year. Dr. Roy Baynes, Senior Vice President and Head of Global Clinical Development and Chief Medical Officer of the
Mercedon Research Laboratory, said, "Serotonin-related diseases not covered by the currently available pneumococcal binding vaccine are increasing worldwide and may vary by country or region.
addition, we continue to see pneumococcal diseases caused by serotoning in existing pneumococcal vaccines.
, scientific innovations in the prevention of pneumococcal diseases are needed to target serotoning, which poses the greatest risk to a particular population, while maintaining an immune response as new serotonies increase.
phase 3 data show that V114 has a strong immune response to all 15 serotypes included in the vaccine and enhances the vaccine's potential to help protect adults from pneumococcal disease.
images from: firstcry.com there are more than 90 different types of pneumococcal bacteria, which affect adults differently than children.
pneumococcal serotypes (e.g. 22F and 33F) that are not included in the currently available combination vaccine are usually associated with invasive pneumococcal diseases worldwide.
Currently, 13 percent of invasive pneumococcal disease in adults 65 years of age and older in the United States is caused by serotypes 22F and 33F, while across Europe, adult pneumococcal disease caused by these two serotypes accounts for 7 to 12 percent.
addition, serotype 3 remains one of the main causes of invasive pneumococcal disease in adults and children, although it is included in the pneumococcal vaccine currently available.
the United States, 15 percent of invasive pneumococcal disease in adults 65 years and older is still caused by serotype 3;
V114 is a 15-price pneumococcal binding vaccine developed by Mercaton and is currently being clinically developed in Phase III for the prevention of pneumococcal disease in adults and children.
V114 is a combination of pneumococcal polysaccharides from 15 serotypes and CRM197 vector proteins, including 22F and 33F serotypes, which are commonly associated with invasive pneumococcal diseases worldwide but are not included in the pneumococcal binding vaccine currently licensed for adult use.
In January 2019, the FDA granted V114 Breakthrough Drug Qualification (BTD) for the prevention of invasive pneumococcal disease (IPD) caused by vaccine serotypes in infants and adolescents between 6 weeks and 18 years of age.
V114's Phase III Clinical Development Program consists of 16 clinical trials that examine V1114's safety, tolerance, and immunogenicity in different populations, including healthy older people, healthy children, people with impaired immune function, and people with certain chronic diseases.
plans to continue working with the U.S. Food and Drug Administration (FDA) and other regulators around the world to submit applications for the V114 vaccine after additional data from Phase III is available.
() Origin: Merck Announces Positive Topline Results from Two Phase 3 Adult Studies Evaluating V114, Merck's Investigational 15-valent Pneumoccal Conjugate Vaccine, Including Pivotal Trial.