Pfizer launched 4 Phase III clinical trials to evaluate three vaccines in development: 20 pneumonic pneumonia vaccine, RSV vaccine, 5-valent meningitis vaccine!
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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 24, 2020 /PRNewswireBiovalleyBIOON/--Pfizer
(
) has announced the launch of four Phase IIIclinical trialsto evaluate several vaccines in its pipelinetwo studies (NCT04382326 and NCT04379713) will be conducted in infants and young children older than 2 months to evaluate a 4-needle immune procedure for the 20-valent pneumococcal polysaccharide-binding vaccine 20vPnCThe two studies will expand data on vaccine safety and tolerance of 20vPnC in infants, and will include a control group of 13 ® (Prevnar 13®, pneumococcal 13 gin-binding vaccine (diphtheria CRM197 protein))Among them, the purpose of the study of NCT04382326 is to determine the non-poor efficacy ofimmunologybetween 20vPnC and 13 ®, which is a key requirement for vaccine licensing1 study (NCT04424316) will be conducted in pregnant women, a randomized, double-blind, placebo-controlled study that assesses maternal immunity of RSVpreF, a candidate vaccine for respiratory syncytial virus (RSV), to prevent the safety and effectiveness of lower respiratory diseases (LRI) in infants1 study (NCT04440163) will be conducted in adolescents and young adults to assess the safety, tolerance and immunogenicity of the 5-valent meningococcal vaccine Menocococcal and the listed meningococcal vaccine, with the aim of determining the non-disadvantaged efficacy ofimmunology"The simultaneous launch of four Phase III studies in the vaccine pipeline reflects Pfizer's continued commitment to unlocking the potential promise and value of the vaccine," said Dr Kathrin U Jansen, Senior Vice President and Director of Vaccines at Sanofi If approved, all three vaccine candidates could help prevent serious, potentially fatal infectious diseases that can have a negative impact on millions of people of different ages around the world "
- 20vPnC: this is a 20-price pneumococcal polysaccharide-binding vaccine that includes 13 serotypes (1, 3, 4, 5, 6A, 6B) contained in 13 ® (Prevnar 13®) 7F, 9V, 14, 18C, 19A, 19F and 23F, and 7 new serotypes (8, 10A, 11A, 12F, 15BC, 22F and 33F) These seven new serotypes are global causes of invasive pneumococcal disease, of which 6 (8, 10A, 11A, 15BC, 22F and 33F) are associated with high fatality rates, and 4 are associated with antibiotics resistance (11A, 15BC, 22F and 33F) and/or meningitis (10A, 15BC, 22F and 33F) Previously, the FDA granted 20vPnC a breakthrough drug (BTD) for the prevention of invasive diseases and pneumonia in adults 18 years and older In September 2017 and May 2019, the FDA awarded 20vPnC fast-track (FTD) for adult and pediatric indications, respectively - RSVpreF: this is a candidate for respiratory syncytial virus (RSV) vaccine, designed to protect infants from lower respiratory diseases (LRI) through maternal immunity In April, the IIb proof-of-concept study, which received positive top-line results, will be detailed at a future medical conference In November 2018, the FDA granted RSVpreF Fast Track (FTD) to prevent RSV-related lower respiratory diseases in infants through active immunity in pregnant women - MenABCWY: this is a five-price meningococcal vaccine that combines two approved meningococcal vaccines, Nimenrix (A, C, W-135, Group Y meningococcal combination vaccine) and Trumenba (Group B meningococcal vaccine) Meningococcal disease is a rare but serious disease that can occur without warning and can lead to meningitis and severe blood infections The majority of invasive meningococcal disease worldwide can be attributed to five types of neissement of meningococcal bacteria (A, B, C, W, Y) These meningococcal groups contribute to 96% of all invasive meningoccal disease (IMD), with Group B accounting for the majority of adolescent and young adult diseases in the United States and Europe (BioValleyBioon.com) original source: Pfizer Announces Start of Four 3 Clinical Trials for .
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