Navigation Links
Baxter Announces Final Phase I/II Data and Initiation of Phase III,Clinical Trial for Candidate Pandemic H5N1 Influenza Vaccine

based candidate H5N1 pandemic vaccine to undergo clinical evaluation.

Final Phase I/II Data Presented

Final data from the Phase I/II clinical trial presented last month at the IV International Symposium on Respiratory Viral Infections in Hong Kong showed the candidate vaccine to exhibit a tolerability profile similar to currently marketed, egg-based seasonal flu vaccines, while delivering high immunogenicity even at low doses. The data also showed the candidate vaccine to induce substantial levels of cross immunity against widely divergent H5N1 strains.

The Phase I/II trial tested four different antigen concentrations, ranging from 3.75mcg to 30mcg; 7.5mcg and 15mcg formulations were studied with and without adjuvant. In the 7.5mcg formulation without adjuvant, the seroprotection rate (based on neutralizing antibodies) at day 42 was 76.2 percent. Immunity induced by the vaccine also neutralized divergent H5N1 virus strains like the Clade three strain A/Hong Kong/156/97, and the Clade two strain A/Indonesia/05/05.

The most common side effects observed were injection site reactions, headaches and fatigue. The minimal occurrence and low level of side effects are similar to those reported for licensed egg-based, seasonal influenza vaccines. These final data confirm the preliminary results of this study previously announced. Comprehensive analyses of the results of the Phase I/II clinical trial are currently being prepared for submission to a peer-reviewed medical journal.

"Baxter is very pleased that our development approach of using vero cell technology and a whole virus formulation is supported by these Phase I/II results. These preliminary results suggest that the vaccine produces a highly immunogenic vaccine with a favorable safety profile without the need for an adjuvant to boost the immune response. Adjuvant can add considerable cost and may have a negative effect on tolerability," said Dr. Hartmut Ehrlich, vice president of Glob
'"/>




Page: 1 2 3 4 5

Related medicine technology :

1. Baxter Presents Phase I Inhaled Insulin Study Results at Respiratory Drug Delivery Conference
2. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
3. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
4. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
5. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
6. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
7. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
8. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
9. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
10. Protox Announces Positive Clinical Data from Prostate Cancer Study
11. Inspire Announces Webcast of Presentation at C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
Post Your Comments:
(Date:11/28/2008)...28 German biotech company,Partec ...HIV monitoring and,AIDS patient follow-up diagnos...e year 2008, 2.5 million patient tests have been p...ordable "CyFlow" system, supporting already,more ... introduction of the,Partec innovation, the avera...
(Date:11/26/2008)...utomation and intelligent clinical applications ta... level , , CHICAGO, Ill., Nov. 26 /PRNewswi...ens.com/healthcare ) highlights the ACUSON S2000(...e world,s first multi-use, automated volume breast...y and Annual Meeting of the Radiological Society o...
(Date:11/25/2008)...against expanding statin use broadly in wake of AH...ov. 25 JUPITER, a clinical trial s...r risk of healthy patients with elevated CRP, shou..., according to a national poll directed at health ...n the online poll conducted by medical news site M...
(Date:11/25/2008)...l Trial to Assess Survival of Patients Receiving L...able Hepatocellular Carcinoma , , BELLEVUE,...ology, Inc. (LSO) today announced the completion o... Light Infusion Therapy(TM) (Litx(TM)) as a treatm...), also known as hepatoma or primary liver cancer....
Breaking Medicine Technology:German Innovation for HIV/AIDS Diagnostics has Been Used 2.5 Million Times in 2008 2Siemens Introduces New Standard of Care for Breast Ultrasound 2Siemens Introduces New Standard of Care for Breast Ultrasound 3Siemens Introduces New Standard of Care for Breast Ultrasound 4Siemens Introduces New Standard of Care for Breast Ultrasound 5Dramatic JUPITER Findings Fail to Sway Prescribing Behavior, Poll Shows 2Dramatic JUPITER Findings Fail to Sway Prescribing Behavior, Poll Shows 3Light Sciences Oncology Completes Patient Enrollment in Phase 3 Clinical Trial of Litx as a Treatment for Hepatocellular Carcinoma 2Light Sciences Oncology Completes Patient Enrollment in Phase 3 Clinical Trial of Litx as a Treatment for Hepatocellular Carcinoma 3Light Sciences Oncology Completes Patient Enrollment in Phase 3 Clinical Trial of Litx as a Treatment for Hepatocellular Carcinoma 4Veterans for Americas 28VFA 29 Wounded Warrior Outreach Program Responds to Fort Drum in Aftermath of Report 12408 1Veterans for Americas 28VFA 29 Wounded Warrior Outreach Program Responds to Fort Drum in Aftermath of Report 12408 2New York Strengthens Emergency Preparedness with Cardinal Health Ventilators 3443 1New York Strengthens Emergency Preparedness with Cardinal Health Ventilators 3443 2Accumetrics Announces 2428 8 Million Financing and Initiation of Pivotal Clinical Trial 1406 1Accumetrics Announces 2428 8 Million Financing and Initiation of Pivotal Clinical Trial 1406 2Major scientific push to tackle agricultural productivity and food security in developing world 2285 1Major scientific push to tackle agricultural productivity and food security in developing world 2285 2Major scientific push to tackle agricultural productivity and food security in developing world 2285 3
(Date:12/2/2008)...NDO, Fla., Dec. 2 MEDai, Inc., hea...olutions provider, has added a new module,to its ...The new stand-alone,module monitors a population,...s and alerts stakeholders when there has been a de... Navigator Guidelines(TM) provides,real-time deci...
(Date:12/2/2008)...inal Special Features MLS Stars and Promotes Healt.../ -- Juniper Content Corporation,s (OTC Bulletin ...astest-growing Spanish-language children,s network... special Juega Como un MLS Pro , the climax of th...ue Soccer, on Sunday, December 7th at 7 PM EST. ,...
(Date:12/2/2008)...cts to File NDA with FDA in Early to Mid-2009 , ... Rx, the developers of PharmFilm(R) technology and...g thin film pharmaceutical products, and Strativa ... of Par Pharmaceutical Companies, Inc. (NYSE: PR...all pivotal bioequivalence studies for a thin film...
(Date:12/2/2008)...IN, China, Dec. 2 /PRNewswire-Asia-FirstCall/ -- C...l" or "the Company") (Nasdaq: CSKI ), a leading,... over-the-counter drugs in,the People,s Republic ...(Stanley) Hao was appointed Chief Financial Office...y,s Board of Directors. He replaces Yu-kun Zhang,...
Breaking Medicine News(10 mins):Health News:MEDai Evidence-Based Guideline Reporting Provides Decision Support at Point of Care 2Health News:Sorpresa! Premieres Juega Como un MLS Pro 2Health News:MonoSol Rx Successfully Completes Pivotal Bioequivalence Studies for Ondansetron Thin Film NDA 2Health News:MonoSol Rx Successfully Completes Pivotal Bioequivalence Studies for Ondansetron Thin Film NDA 3Health News:China Sky One Medical, Inc. Appoints Yu-bo Hao as CFO 2Health News:China Sky One Medical, Inc. Appoints Yu-bo Hao as CFO 3
...or most teenagers a run up the stairs is simply th...or others the resulting breathlessness// and pound...icting a future vulnerability to panic symptoms. ...f Arkansas psychologist, has found that adolescent...
... certain gonorrhea strain has titillated the curio...enzyme, called prolyliminopeptidase//, which helps...s strain of gonorrhea. The existing diagnostic eva...w strain, making detection of gonorrhea extremely ...
... new research shows that nonsurgical embolization ...ecurrence rate and much quicker recovery than surg...eins in the testicle and scrotum). This condition ...ility problems—and can greatly impact quality of l...
...ew Delhi: India witnesses nearly 1.8 million tuber...menace the government// has cleared Rs. 11.56 bill...(RNTCP)-Phase II. As per government estimates, n...infected with TB bacillus but only 10 percent brea...
Other Medicine News:Health News:Panic may Lead to Serious Mental Health Problems in Adolescents 2Health News:Nonsurgical Therapy Highly Effective for Pain and Infertility in Men 2Health News:Government Allot More Funds for Revised TB Program 2
VACUETTE paediatric tubes have decreased sample volumes and are ideal for small childrens' veins and geriatric patients.
BD Vacutainer® Plus Plastic Serum Tubes have spray-coated silica and are used for serum determinations in chemistry, serology, and immunohematology.
Inquire
The inner wall of the tube is coated with spray-dried lithium, ammonium or sodium heparin. These additives are anti-coagulants, which activate anti-thrombins, thus blocking the coagulation cascade of
Medicine Products: