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

 

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Today's News

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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