NIAID-sponsored clinical trial aims to boost flu vaccine supply

In an effort to expand the supply of flu vaccine available in the United States in the future, a clinical trial of an influenza vaccine widely used in Europe has begun recruiting participants at four sites nationwide. Funding for the study comes from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, which is collaborating with the vaccine's manufacturer, GlaxoSmithKline Biologicals of Rixensart, Belgium, to conduct the study.

The new trial aims to enroll 1,000 healthy adults by December 23rd to assess the immune response and safety of the vaccine. More than 126 million doses of the test vaccine, Fluarix, have been distributed in more than 70 countries worldwide, demonstrating a similar safety profile as U.S.-licensed injectable flu vaccine, but the Fluarix vaccine has never been tested or licensed for use in the United States.

On December 7, however, Department of Health and Human Services Secretary Tommy G. Thompson announced approval of a plan to import up to 4 million doses of Fluarix to be distributed as an "investigational new drug" (IND). Under an IND, volunteers given the Fluarix vaccine must first sign an informed consent form acknowledging that they are aware of the potential risks and benefits associated with the investigational vaccine.

HHS has taken this step to augment the U.S. influenza vaccine supply because earlier this year one of the two manufacturers of U.S.-licensed injectable flu vaccine was unable to deliver its product.

"Expanding the number of influenza vaccine sources is critical as we ready ourselves for next year's flu season," says NIAID Director Anthony S. Fauci, M.D. "The NIAID-supported Vaccine and Treatment Evaluation Units (VTEUs) are structured to perform clinical trials efficiently, enabling us to get needed information rapidly."

"Although the vaccine we are testing has a very long safety record in Europe and other parts of the

Contact: Anne A. Oplinger
NIH/National Institute of Allergy and Infectious Diseases

Page: 1 2

Related medicine news :

1. British hospitals need clinical ethicists
2. Lack of clinical trial participation may contribute to lower survival rates
3. Obtaining patient consent for clinical audit is unworkable without extra resources
4. Sharing clinical trial results with participants may be beneficial
5. Two years after gene therapy treatments, severe angina patients showed prolonged clinical benefit
6. PENN begins clinical trial of newest technology to treat thoracic aortic aneurysms
7. Most episodes of HIV blips not clinically significant in patients receiving HAART
8. NIAID seeks applicants to lead clinical trials units for revamped HIV/AIDS networks
9. New non-hormonal hot flash treatment set for clinical trial
10. Study naming hospitals in top 5% for clinical quality released by HealthGrades
11. Future of clinical medicine research is at risk, warns professor

Post Your Comments:

(Date:9/2/2020)... ... September 02, 2020 , ... RAM Technologies, ... administering Medicare Advantage and Special Needs plans, is proud to support the 2020 ... Plans (AHIP). RAM is supporting the event as a sponsor and exhibitor and ...
(Date:9/1/2020)... ... September 01, 2020 , ... Feeding Matters , the first organization in ... Disorder (PFD), is pleased to announce that the U.S. Centers for Disease Control and ... in the next edition of the U.S. International Classification of Diseases (ICD ) ...
(Date:8/31/2020)... ... 31, 2020 , ... Cardiothoracic surgeons at Allegheny General Hospital ... Mellon University (CMU) to develop a new heart monitoring device designed to serve ... , The AGH/CMU team was recently awarded a “Trailblazer” grant from the National ...
(Date:8/31/2020)... ... August 31, 2020 , ... ... 1,400 N95 face masks to medical first responders across the United States. Since ... donations of personal protective equipment (PPE) medical centers , hospitals , ...
(Date:8/31/2020)... ... August 31, 2020 , ... Colorado State University ... career-relevant, and affordable online education – is proud to announce its new master’s ... first of its kind in the nation, the 60-credit hour program is designed ...
Breaking Medicine News(10 mins):
(Date:9/1/2020)... ... September 01, 2020 , ... September is National Ovarian Cancer Awareness ... deaths than any other cancer of the female reproductive system. The American Cancer ... and about 14,000 women will die from this disease. Throughout the month of ...
(Date:8/31/2020)... , ... August 31, 2020 , ... ... and advisory guide, has named Cloudticity a Gold winner in the 15th Annual ... and peer recogniti o ns from Network Products Guide honoring achievements ...
(Date:8/27/2020)... CONSHOHOCKEN, Pa. (PRWEB) , ... August 27, 2020 ... ... and care coordination software, today announced the successful completion of their 2020 System ... as well as their HITRUST® interim assessment and MARS-E compliance assessment. These achievements ...
Breaking Medicine Technology:
Cached News: