The major problem with this study, as in with virtually all of them, is the comparison is to other vaccinated people. It's the classic problem when there is no actual control group. In this case the "control" group is children getting separate vaccines. If separate vaccines are unsafe, then the correct conclusion for this study should be that the combination vaccine is as UNSAFE as separate ones. - SM
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/10-29-2001/0001603236&EDATE=
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Study Shows
Aventis Pasteur's Candidate Pediatric Combination Vaccine to Be As Safe as
Single Component Vaccines Currently in Use DTaP/IPV/Hib Vaccine Safety Data Studied in Multi-Center Trial MONTEREY, Calif., Oct. 29 /PRNewswire/ -- In a study presented today at the 3rd International Pediatric Infectious Disease Conference, Aventis Pasteur Inc.'s candidate pentavalent pediatric vaccine was shown to be as safe as currently used single-component vaccines when given concurrently with other recommended childhood vaccines. The combination vaccine, which includes pertussis, diphtheria, tetanus, poliomyelitis and Haemophilus influenzae type b (Hib) components, is currently being studied in ongoing randomized multi-center trials for use in the United States and has been licensed for pediatric use in ten countries, including Canada, where it is registered under the tradename Pentacel(R). "The development of safe pediatric combination vaccines is an important research priority that will help ease physician and parental concerns about multiple injections while potentially having the added public health benefit of improving our national immunization rates," said Steven Black, M.D., Kaiser Permanente, who is the study's principal investigator. "Historically, ideal pertussis-based combination vaccines have been difficult to achieve because of immune interference or reactogenicity, but this vaccine could hold the promise of potentially overcoming such hurdles. According to the currently recommended childhood immunization schedule, infants may receive up to five injections during a visit to the pediatrician's office. A five component vaccine would reduce that number to three. "Aventis Pasteur is committed to developing safe and effective combination vaccines that build upon its existing expertise," said Clotilde Thiriart, vice-president, research and development for Aventis Pasteur Inc. "This study is an important milestone in bringing more advanced combination vaccines to the U.S. market." The ongoing randomized multi-center study is being conducted in the U.S., with the current data comparing the safety and immunogenicity of the five component vaccine to the separate administration of its individual vaccines (DTaP/IPV/Hib) in 2,503 subjects. After the first dose of the combination vaccine, subjects had less redness (19.3% versus 24.3%), swelling (12.4% versus 16.1%), and tenderness (39.5% versus 58.6%) of any severity than the 1,031 subjects in the control group at the DTaP injection site. In addition, subjects in the combination vaccine group had a lower rate of fever, fussiness, crying, and other adverse events typically associated with the administration of some DTaP vaccines. Preliminary data in this ongoing study indicate that a similar low-incidence of adverse events was observed after the 2nd and 3rd dose of the vaccine was administered; no serious adverse events were reported at this time. Part II of the ongoing study will evaluate the safety and immunogenicity of combination and component vaccines at 15 months of age. Aventis (NYSE: AVE), a world leader in pharmaceuticals and agriculture, is dedicated to improving life through the discovery and development of innovative products. In 2000, Aventis generated group sales of $20.6 billion and employed around 92,500 people in its Pharma and Agriculture businesses. Aventis announced in November 2000 that it intends to focus on pharmaceuticals and plans to divest its activities in agriculture. Aventis was launched in December 1999 through the merger of Hoechst AG of Germany and Rhone-Poulenc SA of France. Corporate headquarters are in Strasbourg, France. For more information, please visit: http://www.aventis.com Aventis Pasteur, a world leader in vaccines with the broadest range of products, produces more than one billion doses of vaccines every year to immunize 400 million people around the world. Aventis Pasteur, headquartered in Lyon, France, is one of the pharmaceutical activities of Aventis SA. Aventis Pasteur Inc. is located in Swiftwater, PA, and is owned by Aventis Pasteur SA. Aventis Pasteur Inc. provides the broadest range of human vaccines and biologicals commercially available from any single U.S. vaccine company. It is a leading supplier of vaccines to protect against influenza, diphtheria, tetanus, pertussis, polio, Japanese encephalitis, yellow fever, Haemophilus influenzae type b disease, meningitis, rabies, and typhoid fever. Statements in this news release other than historical information are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission. SOURCE Aventis Pasteur Inc. Web Site: http://www.aventis.com |
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ALL
INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR
GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE
KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED
AS PROVIDING MEDICAL OR LEGAL ADVICE. THE DECISION WHETHER OR NOT TO
VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU
ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.