Navigation Links
New Phase 3 Data Continue to Indicate that Wyeth's Investigational 13-valent Vaccine Has the Potential to Broaden Coverage Against Pneumococcal Disease
Date:6/11/2009

<24 months; and 3) a single dose of Prevenar 13 at age 24 to <72 months. Each of the 3 regimens was shown to elicit immune response levels against all 13 serotypes that were either comparable to or greater than the IgG antibody concentrations achieved in infants after a 3-dose infant series and to have acceptable tolerability and safety profiles.

Overall, the most frequently reported adverse events in the Phase 3 trials included injection site reactions, (redness, swelling, and tenderness), fever (greater than or equal to 38 degrees C/100.4 degrees F), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea and rash.

Health Economic Models

Three health economic models presented at ESPID estimated the potential public health and economic impact of Prevenar 13. The results of the analyses in the Netherlands, the UK, and Germany and the US suggested that the introduction of Prevenar 13, if approved, to national immunization programs has the potential to further reduce PD levels in children who are vaccinated as well as in the unvaccinated population (through a herd effect). Based on these economic models, the researchers estimated that routine vaccination with Prevenar 13 could be cost effective or cost saving.

Registration Status

To date, Wyeth has submitted regulatory applications for the pediatric use of Prevenar 13 in more than 45 countries. In December 2008, Wyeth submitted a marketing authorization application (MAA) for Prevenar 13 to the European Medicines Agency (EMEA). In March 2009, Wyeth submitted a Biologic License Application (BLA) for Prevenar 13 to the U.S. Food and Drug Administration (FDA). Last month, the FDA granted the BLA priority review -- a designation given to products that, if approved, would be a significant therapeutic or public health advance. Prevenar 13 is also being studied in
'/>"/>

SOURCE Wyeth Pharmaceuticals
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related biology technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
3. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
4. ONCOSCIENCE AG, THE EUROPEAN PARTNER OF YM BIOSCIENCES, ANNOUNCES COMPLETION OF PATIENT ENROLLMENT IN PHASE III BRAIN CANCER TRIAL OF NIMOTUZUMAB
5. Evotec to Present Details of the Positive Phase II Study in Insomnia With EVT 201 at the Worldsleep07 Congress in Cairns/Australia
6. Phase III Trial Finds Pharmaxis Bronchitol Effective
7. YM BioSciences USA cleared by US FDA to initiate Phase II clinical trial of nimotuzumab in children with inoperable, recurrent brain cancer
8. YM BIOSCIENCES ANNOUNCES POSITIVE PRELIMINARY RESULTS FROM PHASE I/II LUNG CANCER TRIAL OF NIMOTUZUMAB COMBINED WITH RADIATION
9. Exelixis Reports Encouraging Interim Data From a Phase 2 Trial of XL647 as First-Line Therapy for Non-Small Cell Lung Cancer
10. Evotec Reports Details of the Positive Proof-of-Concept Phase II Study in Insomnia With EVT 201
11. Stimuvax(R) Phase II data highlight three-year survival results for patients with non-small cell lung cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/18/2014)... 2014 Reflecting the importance of the evolution ... Connie Rankin, the founder and president of Customized ... introduced a fresh new approach to the firm’s branding. ... to influence the success of his or her commercial clients ... one of the first in this market to fully embrace ...
(Date:7/18/2014)... 18, 2014 Global biotechnology company ... offices in Cambridge, MA, announces the launch of ... Software product that leverages the power of Next ... MiSeq sequencing platform. The assay and software have ... of Philadelphia (CHOP) and will include a new ...
(Date:7/18/2014)... 18, 2014  On July 18, 2014, ... Shire,s complementary fit and the benefits of ... of the infographic materials will be available ... In accordance with Rule 30.4 ... this announcement will be available on AbbVie,s ...
(Date:7/18/2014)... -- The Basel Declaration presented the ... consecutive year. The award winner, Vladimir Sergeevich Popov from ... at Zürich University for research with animals according to ... head of the animal research laboratory at the Moscow ... adapting experimental animal research as well as student training ...
Breaking Biology Technology:LEED AP Certified ITRA Global / Customized Real Estate Services Introduces New Approach to Its Branding 2Omixon Launches Holotype HLA for NGS-based HLA Genotyping 2Omixon Launches Holotype HLA for NGS-based HLA Genotyping 3NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION 2NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION 3NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION 4NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION 5NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION 6NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION 7Young Moscovite Researcher Receives this Year's "Basel Declaration Award for Education in Animal Research" 2
... VNUS(R) Medical,Technologies, Inc. (Nasdaq: VNUS ), a leading ... venous reflux disease, today,announced the hiring of Guido Smeets, ... Officer., Dr. Smeets joins VNUS with over 17 ... served as the Head of Clinical Affairs for,Pelikan Technologies, ...
... OriGene Technologies, Inc.,announces its flagship products, TrueORF cDNA ... protein) vector, enabling easy transfection,monitoring and protein expression. ... frame) clones and 12,000 mouse ORF clones can ... the 2008 Nobel Prize in chemistry was awarded ...
... ThermoGenesis,Corp. (Nasdaq: KOOL ), a leading supplier ... announced today it will report,financial results for the fiscal ... 2008., Company,s Conference Call and Webcast, Management ... at,2:00 PM Pacific (5:00 PM Eastern) to review the ...
Cached Biology Technology:VNUS Medical Technologies, Inc. Announces the Hiring of Guido Smeets, MD, as Vice President of Clinical Research and Chief Medical Officer 2OriGene Announces 37,000 ORF cDNA Clones in a GFP Vector 2ThermoGenesis Corp. to Announce First Quarter Fiscal 2009 Results on November 6, 2008 2
(Date:7/21/2014)... by neurobiologist Luke Remage-Healey at the University of ... the brains of young birds enhance their ability ... development. This period has a parallel to universal ... separate study, the UMass Amherst neuroscientist and colleagues ... the brain,s auditory cortex enhances the representation of ...
(Date:7/21/2014)... traditional apple orchards, effective management practices rely ... manage competitive vegetation under the trees, and ... factors are further complicated in organic management ... producers need to meet the stringent soil ... the National Organic Program. University of Arkansas ...
(Date:7/21/2014)... their body temperature, so their cells are stressed when ... temperatures, some biological processes in the cell are slowed ... delicate chemical balance out of whack. Yet, those cells ... from the University of Rochester and the European Molecular ... , "The production of proteins is a key ...
Breaking Biology News(10 mins):Studying estrogens made by the brain may offer new insights in learning and memory 2Studying estrogens made by the brain may offer new insights in learning and memory 3Organic apple orchards benefit from green compost applications 2When temperatures get cold, newly-discovered process helps fruit flies cope 2
... relatives of spiders that lived around 300 million years ... published today in the journal Biology Letters . ... detailed 3D computer models of two fossilised specimens of ... related to modern-day spiders. The study reveals some of ...
... A gene previously associated with physical traits is also ... a living model of Darwin,s natural selection theory, according ... three to 10 centimetres, stickleback fish originated in the ... the last ice age. Over the past 15,000 years, ...
... in the developing world is the key to ensuring ... Chair of the Global Form on Agricultural Research (GFAR), ... published last week. With nearly a billion people ... major concern, despite being a key goal of the ...
Cached Biology News:Scary ancient spiders revealed in 3-D models, thanks to new imaging technique 2Scary ancient spiders revealed in 3-D models, thanks to new imaging technique 3
Recombinant Mouse MMP-9, CF...
Phosphorylcholine hapten is conjugated to BSA protein by use of p-diazonium phenylphosphorylcholine....
Human/Mouse/Rat JNK Pan Specific Affinity Purified PAb...
TAR DNA binding protein...
Biology Products: