Navigation Links
GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSK's Candidate Pre-pandemic Flu Vaccine to Start.
Date:8/19/2007

ng governments and public health officials around the world effectively respond to the global threat of a flu pandemic and we are pleased to be working with the US government in its preparedness efforts."

Initiation of H5N1 clinical trials

Today also marked the start of the first pre-pandemic vaccine trials involving GSK's proprietary adjuvanted H5N1 vaccine in North America. The vaccine used in these trials will be produced at the company's North American manufacturing facility in Quebec, Canada. These U.S. studies are supported by a contract [HHS100200700029C] from BARDA/ASPR/HHS awarded in January 2007 for the advanced development of antigen-sparing pandemic influenza vaccines towards U.S.-licensure with a commitment to U.S. production of 150 million doses of pandemic vaccine within six months of a pandemic onset.

The trials highlight the company's continuing commitment to its global pre-pandemic influenza vaccine development program. Data from earlier European studies, using a pre-pandemic vaccine produced at GSK's Dresden, Germany facility, showed that the influenza candidate vaccine may be able to induce immune responses that might protect against different strains of H5N1.

GSK's first North American pre-pandemic vaccine trial will be a Phase I/II study that evaluates its H5N1 antigen alone and in combination with one of its proprietary Adjuvant Systems, in 675 subjects. This Phase I/II study is expected to lead into a larger, multi-center, Phase III trial - one of the largest in North America - which is expected to enroll approximately 4,400 subjects later in 2007.

Ripley Ballou, Vice President of Clinical Development for Flu at GlaxoSmithKline said: "The goal of our North American clinical development program is to establish GSK's second manufacturing facility as a source for H5N1 vaccine, further strengthening our efforts to support governments' pandemic preparedness strategies. The initiation of these trials underscores the im
'/>"/>

SOURCE GlaxoSmithKline

Copyright©2007 PR Newswire.

Page: 1 2 3 4

Related medicine technology :

1. GlaxoSmithKline and Genmab Present Positive Phase II Results With ofatumumab in Patients With Rheumatoid Arthritis (RA)
2. GlaxoSmithKline’s Hib-MenCY-TT Combination Vaccine Meets Phase II Study Endpoints of Immunogenicity and Safety Compared to Licensed Vaccines
3. New Data on Genmab and GlaxoSmithKlines Ofatumumab: Phase II Study in Rheumatoid Arthritis to be Presented at EULAR
4. Sirion Therapeutics Receives Orphan Drug Designation for Ophthalmic Drug to Treat Viral Eye Infection
5. Protalix BioTherapeutics, Inc. Receives Approval from the FDA to Initiate a Phase III Clinical Trial of prGCD
6. DUSA Pharmaceuticals Receives Orphan Drug Desi gnation for Levulan PDT to Treat Esophage al Dysplasia
7. Gloucester Pharmaceuticals Receives Fast Track Designation for Romidepsin in Peripheral T-Cell Lymphoma
8. Researchers Discover Gene For Rare Skin Disorder
9. Remarks by President Bush on Stem Cell Veto and Executive Order
10. IMPAX Presents at Movement Disorder Societys 11th International Congress of Parkinsons Disease and Movement Disorders
11. International Movement Disorder Specialists Receive New Information About the Use of Once-Daily Azilect in the Treatment of Parkinsons Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/21/2014)... Nov. 21, 2014  Abaxis, Inc. (NasdaqGS: ... and consumables for the medical, research, and veterinary markets ... and research markets in the United States ... purchase agreement to acquire 100% of QCR & Trio ... based distribution organization. The transaction closed on November 17, ...
(Date:11/21/2014)...  Edwards Lifesciences Corporation (NYSE: EW ), ... and hemodynamic monitoring, announced today that it will increase ... strong launch of Edwards Lifesciences Foundation,s new charitable initiative, ... global communities where its employees live and work. ... exceed $8 million, including more than $7 million in ...
(Date:11/21/2014)... Calif. , Nov. 20, 2014  The ... at the 2014 AAGL Global Congress demonstrates continued ... insert designed to provide bowel control. One of the ... Associate Professor and Division Chief of Urogynecology and ... Carolina, won an Award for Best Written Abstract ...
Breaking Medicine Technology:Abaxis Acquires UK-based Distribution Organization 2Abaxis Acquires UK-based Distribution Organization 3Abaxis Acquires UK-based Distribution Organization 4Edwards Lifesciences Increases Charitable Giving In 2014 To Support Launch Of Every Heartbeat Matters 2LIFE Study Prominently Featured at Minimally Invasive Gynecology Conference 2LIFE Study Prominently Featured at Minimally Invasive Gynecology Conference 3
... recently launched eCS Inpatient EHR V1.2 (eCS), the first ... medium hospitals. eCS,s uniqueness is the tight linkage of ... a single web-based software solution. The solution is offered ... simplified deployment. "eCS is an affordable solution ...
... than half (55%) of hair loss sufferers would be more ... public figures were more open about hair restoration surgery, and ... vs. 45%). Over the last couple of years ... Kevin Costner, Mel Gibson, John Travolta, Brendan Fraser, Jude Law ...
Cached Medicine Technology:eCareSoft Launches Comprehensive EHR for Small & Medium Hospitals 2More and More Celebrities Are Embracing Hair Restoration 2
(Date:11/23/2014)... York, NY (PRWEB) November 23, 2014 ... the past month in a federal litigation involving Byetta ... similar diabetes medications, Bernstein Liebhard LLP reports. , ... 566 claims over a class of Type 2 diabetes ... filed in the U.S. District Court, Southern District of ...
(Date:11/23/2014)... Beach, CA (PRWEB) November 23, 2014 ... of American Medical Aesthetics & Wellness was recently ... Asher Milgrom, Ph.D. is president and CEO of American ... Dr. Asher Milgrom received a full scholarship to ... and the Medical School at the University of Chicago, ...
(Date:11/23/2014)... VA (PRWEB) November 23, 2014 The ... Have in Common, **FDAnews On-Demand Webinar**, Dec. 11, 2014 ... , The FDA’s focus on promotional activities is ... , Now they're looking at websites, Twitter, journal ... the calendar for Thursday, Dec. 11, for On-Demand access ...
(Date:11/23/2014)... (PRWEB) November 23, 2014 Wright & ... behalf of Ohio and West Virginia residents who allege ... health disorders due to drinking C8 contaminated water ... Parkersburg, West Virginia. According to the C8 complaints, the ... either worked or lived in at least one of ...
(Date:11/23/2014)... (PRWEB) November 23, 2014 Today ... reimbursement for small businesses, announced their new on ... End of Employer-Provided Health Insurance. , ... the greatest financial risk facing most American families. ... employers, small and large, when it comes to ...
Breaking Medicine News(10 mins):Health News:California Federal Court Overseeing Byetta Lawsuits, Other Incretin Mimetic Claims Adds New Cases in November, Bernstein Liebhard LLP Reports 2Health News:California Federal Court Overseeing Byetta Lawsuits, Other Incretin Mimetic Claims Adds New Cases in November, Bernstein Liebhard LLP Reports 3Health News:California Federal Court Overseeing Byetta Lawsuits, Other Incretin Mimetic Claims Adds New Cases in November, Bernstein Liebhard LLP Reports 4Health News:Asher Milgrom Is the Founding Doctor of AMA Skincare and Is Featured in the International Business Times 2Health News:Asher Milgrom Is the Founding Doctor of AMA Skincare and Is Featured in the International Business Times 3Health News:Asher Milgrom Is the Founding Doctor of AMA Skincare and Is Featured in the International Business Times 4Health News:FDAnews Announces The FDA is Watching: What Twitter, Tradeshows and TV Have in Common, On-Demand Webinar, Dec. 11, 2014 2Health News:FDAnews Announces The FDA is Watching: What Twitter, Tradeshows and TV Have in Common, On-Demand Webinar, Dec. 11, 2014 3Health News:FDAnews Announces The FDA is Watching: What Twitter, Tradeshows and TV Have in Common, On-Demand Webinar, Dec. 11, 2014 4Health News:FDAnews Announces The FDA is Watching: What Twitter, Tradeshows and TV Have in Common, On-Demand Webinar, Dec. 11, 2014 5Health News:40 C8 Lawsuit Claims Filed By Wright & Schulte LLC Alleged Serious Illness Due To C8 Contaminated Water In Ohio And West Virginia 2Health News:40 C8 Lawsuit Claims Filed By Wright & Schulte LLC Alleged Serious Illness Due To C8 Contaminated Water In Ohio And West Virginia 3Health News:40 C8 Lawsuit Claims Filed By Wright & Schulte LLC Alleged Serious Illness Due To C8 Contaminated Water In Ohio And West Virginia 4Health News:Zane Benefits, Inc. Announces New Webinar on The End of Employer-Provided Health Insurance Now Available On-Demand! 2
... Society for Microbiology (ASM) will hold its 111th ... Louisiana. The meeting will feature approximately 3,000 ... and has an expected attendance of 10,000. ... their work is critical to human and animal ...
... HealthDay Reporter , THURSDAY, March 3 (HealthDay News) -- A new ... a position thought to pose a risk for SIDS -- have ... on their backs. The discovery suggests that a lack of ... at a higher risk of sudden infant death syndrome while sleeping: ...
... Unexpected results from a Scripps Research Institute and ModGene, LLC ... the liver instead of the brain as the source of ... this devastating condition. The findings could offer a relatively simple ... published online today in The Journal of Neuroscience Research. ...
... have synthesized the vast literature on cancer to produce ... amongst all cancer cells. These hallmarks of the ... field that will influence biomedical researchers in their quest ... article by Douglas Hanahan of cole Polytechnique Fdrale in ...
... , WEDNESDAY, March 2 (HealthDay News) -- People with ... than those without the disease -- and it,s not ... vascular problems caused by diabetes, people with the blood ... from many other causes, including cancer, infections, falls, liver ...
... On March 3, 2011 Men living in low-income ... each week compared to women in these neighbourhoods, according to ... The findings, published in the Journal of Epidemiology ... women differently when it comes to alcohol consumption. Heavy drinking ...
Cached Medicine News:Health News:American Society for Microbiology to host 111th General Meeting in New Orleans 2Health News:Research Uncovers Clue to SIDS 2Health News:Scripps Research study points to liver, not brain, as origin of Alzheimer's plaques 2Health News:Scripps Research study points to liver, not brain, as origin of Alzheimer's plaques 3Health News:Scripps Research study points to liver, not brain, as origin of Alzheimer's plaques 4Health News:In search of cancer's common ground: A next-generation view 2Health News:Diabetes Ups Death Risk Overall, Study Shows 2Health News:Men in low income neighborhoods drink more than women: Study 2
... Immunosimplicity (Is) Rubella IgG Test Kit ... qualitative and quantitative detection of antibodies ... performed either manually or in conjunction ... The results are reported in IU/ml,which ...
... is the first,diagnostic hepatitis assay approved by ... run in a random access format on,the ... you,can run a hepatitis test at any ... intended for,the qualitative in vitro determination of ...
... ANOGEN's ELISA-PSA kit is ... the quantitative,measurement of prostatic specific ... This in vitro device is,strictly ... screening, management and prognosis of ...
... a comprehensive line of pregnancy tests including ... in convenient one-step stick and cassette formats. ... Clearview Easy HCG is a 25 mIU ... Clearview HCG II provides 25mIU sensitivity ...
Medicine Products: