Navigation Links
NOVAVAX Completes First Stage of Enrollment in Pivotal H1N1 Influenza Vaccine Study in the Country of Mexico
Date:11/16/2009

ROCKVILLE, Md., Nov. 16 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) announced today that enrollment has been completed in the first stage of a two-stage clinical study of its novel 2009 H1N1 virus-like-particle (VLP) pandemic influenza unadjuvanted vaccine in the country of Mexico. An independent data and safety monitoring board has reviewed preliminary safety data from the first half of this cohort and recommended that this first stage continue as planned. The study is being conducted in Mexico City in collaboration with Avimex Laboratories. The first stage of the study is evaluating the vaccine's safety, immunogenicity and exploratory efficacy among 1,000 healthy adults, including 750 VLP vaccine recipients and 250 placebo recipients. The results of this phase of the blinded, dose-ranging placebo-controlled study will be used to select a dose for evaluation in the second stage of the clinical study in a larger cohort of 3,000 subjects (2,000 vaccine and 1,000 placebo recipients). The results of this study will be used to support registration of Novavax's 2009 H1N1 VLP pandemic influenza vaccine in Mexico as well as in the future development of Novavax's pandemic and seasonal influenza vaccines in other countries.

"We are encouraged by the recommendation of the data and safety monitoring board to continue the trial and plan to begin subjects' enrollment in the second phase of the study as soon as possible," said Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax. "This pivotal trial is advancing rapidly toward completion with the ability to evaluate results early next year. If our findings are positive, Novavax and our partners plan to seek immediate approval to market our VLP-based 2009 H1N1 VLP pandemic influenza vaccine in Mexico, which currently faces a critical shortage of H1N1 influenza vaccine.
'/>"/>

SOURCE Novavax, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Novavax CEO to Present at BIO CEO & Investor Conference
2. Novavax Enters Into Estrasorb(R) Asset Sale and Supply Agreements with Graceway Pharmaceuticals, LLC
3. Graceway Pharmaceuticals, LLC(TM) Announces Completed Acquisition of All Assets Related to Estrasorb(R) Product Line in North America From Allergan, Inc. (NYSE: AGN) and Novavax, Inc. (Nasdaq: NVAX)
4. Novavax CEO to Present at the World Vaccine Congress 2008
5. Novavax Opens Its First U.S. Vaccine Plant
6. Novavax Announces Release Date of 2008 First Quarter Financial Results and Investor Conference Call
7. Novavax Reports First Quarter 2008 Financial Results
8. Novavax CEO to Present at ACUMENBioFins 5th Annual Global Healthcare Conference
9. Novavax CEO to Present at FBR Capital Markets 12th Annual Spring Investor Conference
10. Novavax CEO to Present at Piper Jaffray Europe Conference, London, UK
11. Novavax to Join Russell 3000 Index
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/14/2014)... 14, 2014 As pet owners drew up their lists of ... wrote: "Take better care of my furry companion." Nowadays there are ... top-brand carrying cases to take the little canine or feline darlings ... compelled to buy some pricey toys at the pet store. But ...
(Date:1/14/2014)... 14, 2014 iLab Solutions, the leader in ... new Director of Product Strategy. In this role, Michelle will ... sub-teams to guide in the development of iLab products. Her ... maximum possible benefit to the scientific community by offering the ...
(Date:1/14/2014)...   Kinaxis ®, provider of RapidResponse ®, a cloud-based ... planning ( S&OP ) service, is proud to be a ... be held at the Hilton San Diego Bayfront, January 30 ... Elisabeth Kaszas , Director of Supply Chain at Amgen, as ...
(Date:1/14/2014)... Altadena, CA (PRWEB) January 14, 2014 ... Angeles County), California, and Montreal, Canada, has big ideas ... and non-fiction. The press's goals are to produce high-quality, ... e-books to support local businesses. , The first ...
Breaking Biology Technology:New Year's Resolution: Give Pets the Gift of Top-Notch Health Care 2iLab Solutions Announces Michelle Detwiler as the New Director of Product Strategy 2Event Alert: Kinaxis Customer to Present at the Biomanufacturing Summit "Supply Chain: Improving Network Effectiveness" 2Bitingduck Press Looks Forward to 2014 With Multimedia E-books 2
... Pursues Additional Approvals Globally for Dialysis and Earlier Stage ... Chronic Kidney ... GENZ ) today announced the U.S. launch of the ... progress in its international efforts to secure additional,approvals for the ...
... PharmAthene, Inc., a,biodefense company specializing in the ... biological threats, announced,today that it has completed the ... spectrum chemical nerve agent prophylaxis., The PK ... used the final,pegylated version of rBChE for the ...
... - Continues Consolidation of Competitors in Key Markets ... China Nepstar,Chain Drugstore Ltd. (NYSE: NPD ) ... in China based on the number of directly ... a definitive agreement,with DongGuan Hui Ren Tang Pharmaceutical ...
Cached Biology Technology:Genzyme Launches Renvela(R) in the U.S. for Dialysis Patients 2Genzyme Launches Renvela(R) in the U.S. for Dialysis Patients 3Genzyme Launches Renvela(R) in the U.S. for Dialysis Patients 4Genzyme Launches Renvela(R) in the U.S. for Dialysis Patients 5PharmAthene Completes Pharmacokinetic Studies of Protexia(R); Program on Target for IND Filing in 2008 2PharmAthene Completes Pharmacokinetic Studies of Protexia(R); Program on Target for IND Filing in 2008 3PharmAthene Completes Pharmacokinetic Studies of Protexia(R); Program on Target for IND Filing in 2008 4China Nepstar Chain Drugstore to Acquire 18 Stores from Dongguan Hui Ren Tang Pharmaceutical Co. 2China Nepstar Chain Drugstore to Acquire 18 Stores from Dongguan Hui Ren Tang Pharmaceutical Co. 3China Nepstar Chain Drugstore to Acquire 18 Stores from Dongguan Hui Ren Tang Pharmaceutical Co. 4
(Date:4/23/2014)... researcher has shed light on how an estimated one ... outback have become reviled as pests and culled on ... and Sustainability Institute at the University of Exeter,s Penryn ... from their historic role helping to create the country,s ... , The deserts of the Australian outback are a ...
(Date:4/23/2014)... mammals, ravens form different types of social relationships ... also form strict dominance relations. From a cognitive perspective, ... ability in daily social life ("knowing who is nice ... have with each other sets the stage for "political" ... this study have been published in the scientific journal ...
(Date:4/23/2014)... a 2 million Food Standards Agency (FSA) project to ... industry workers. , Norovirus outbreaks can rapidly affect ... of frozen strawberries infected 11,000 people in Germany, but ... which strains cause infection and which foods are the ... Researchers will produce data that will help the FSA ...
Breaking Biology News(10 mins):How Australia got the hump with 1 million feral camels 2How Australia got the hump with 1 million feral camels 3Ravens understand the relations among others 2
... to promote company,s highly secure, do it ... smartTOUCH(R) finger activated products, JERICHO, N.Y., Sept. 16 ... it has hired Debbe Dunning as,the company,s new spokesperson ... advertising campaign directed at the Home Improvement,market., (Photo: ...
... 16, 2008)- A team of scientists headed by neuroscientist Dr. ... the National Institute of Health (NIH), to develop a technique that ... Chiba, a professor at the University of Miami,s Department of Biology, ... to enhance synapse formation or nerve regeneration., ...
... , Researchers at McGill University and the affiliated Lady ... with colleagues at the University of Ottawa and the Ottawa ... use of viruses to target and destroy cancer cells, a ... the September early edition of the Proceedings of the ...
Cached Biology News:'Home Improvement' Star Debbe Dunning is New smartTOUCH Spokesperson 2'Home Improvement' Star Debbe Dunning is New smartTOUCH Spokesperson 3NIH EUREKA grant awarded to University of Miami scientist 2Viral 'magic bullet' targets cancer cells with help of new compound 2
... Application: A tracking dye for ... polyacrylamide gels including DNA sequencing. Preparation ... 0.05% is recommended. A 2% stock ... 5-10 buffer. Chem comp: Dye ...
... The VSOS-4 Orbital Shaker is designed to ... provide a uniform motion that is both mixing ... VSOS-4 Orbital Shaker provides a smooth, quiet, reproducible ... a wide range of laboratory applications such as ...
... The Biometra TProfessional Thermocycler combines top performance ... block achieves high speed and unparalleled temperature ... display providing programming in a spreadsheet or ... Performance Smart Lid opens on the push ...
... The Synaptic Vesicles Isolation Kit provides ... an enriched synaptic vesicle fraction. The ... lysis of the synaptosomes, and differential ... gradient. The kit also contains an ...
Biology Products: