GSK throws out the flu vaccine Fluarix excellent phase III data! Help children fight the flu
March 8, 2018 Source: CPhI Pharma Online Author: Knowing and Doing
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Spring is hot and cold, and seasonal flu is ravaging the world. Recently, GlaxoSmithKline (GSK) has released positive phase III data from the influenza vaccine Fluarix Tetra, which shows that it can protect children from the flu. This phase III clinical study reached its primary end point, and Fluarix Tetra provides active immunity for children aged 6-35 months, helping children to withstand 63.2% of moderate to severe flu and 49.8% of any flu.
Since the outbreak of the Spanish flu in 1918 and now 2018, humans have experienced four large-scale flu epidemics in 100 years, each causing a large number of deaths, including the Spanish flu in 1918, the Asian flu in 1957, and the flu in 1968 in Hong Kong. Influenza A H1N1 in 2009. The high variability of influenza viruses poses challenges to its treatment and prevention, and the flu virus has a chance to cause several flu outbreaks. Looking for a broad-spectrum antiviral or flu vaccine to become a major pharmaceutical company. The direction of the researchers.
The recent seasonal flu outbreak in 2017/18 has caused a significant number of patients to die, and even in this fight against the flu, the vaccine has played a significant role. The WTO recently issued a statement that four-valent vaccines (two types A and two types B) offer a wider range of protection than trivalent vaccines (two types A and one type B), while GSK's Fluarix Tetra is a A tetravalent flu vaccine.
As a world-class influenza vaccine company, GSK is committed to the development of a new influenza vaccine. The Fluarix Tetra is a four-valent influenza vaccine approved by the FDA in 2012. In 2013, it has entered European countries such as Germany, France and the United Kingdom. It has been used in more than 30 countries around the world. Fluarix Tetra is an influenza vaccine that can be used to boost active immunity in children and children over 6 months and to prevent influenza caused by seasonal influenza A and B viruses.
On March 6, 2018, GSK published a Phase III clinical study of the Fluarix Tetra, reaching two primary endpoints, demonstrating that it can provide active immunity against 63.2% for children aged 6-35 months (97.5% CI: 51.8-72.3) moderate to severe flu and 49.8% (97.5% CI: 41.8-56.8) of any flu. Due to the certain matching degree of Fluarix Tetra to influenza strains, the secondary endpoint data is even better. The effective resistance rate for moderate to severe influenza is 77.6% (97.5% CI: 64.3-86.6), the effective resistance rate of any influenza. It is 49.8% (97.5% CI: 41.8-56.8).
The Phase III clinical trial was a single-blind, multi-country study of observers to assess the effectiveness of a 6- to 35-month-old child's active immunization with the tetravalent vaccine Fluarix Tetra against known strains. The phase III study was conducted by a total of 12018 children from 13 countries (divided into 5 groups), and the researchers conducted observational studies from October 2011 to December 2014 for 3 years.
Thomas Breuer (Image courtesy of GSK's official website)
"Children are at high risk of influenza infection and are prone to complications and serious illnesses, so children around the world play an important role in the spread of influenza," said Thomas Breuer, chief medical officer of the GSK Vaccine Department. This study is the first randomized clinical trial for the evaluation of the efficacy of tetravalent vaccines for children, supplementing data on the role of universal flu vaccine for children over 6 months, inhibiting the spread of influenza."
The study also found that the four-valent influenza vaccine can reduce the impact of the flu on daily health and life, and can reduce the number of doctors, antibiotics, and medical care time by 50%. This is the first time that the quaternary influenza vaccine has the above effects. the study.
Reference source:
1. GlaxoSmithKline's Fluarix protects young children in large phase 3 test;
2. New clinical data demonstrate high vaccine efficacy of Fluarix Tetra (Influenza Vaccine) in children 6-35 months of age.
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