Video: Sanofi Pasteur Announces Final Results of U.S. Clinical Trials of Influenza A (H1N1) Vaccine in Adults and Children
Final data confirm immunogenicity, safety profile - - Single dose provides robust immune response in adults; two doses provide robust immune response in children 6 months through 9 years -
SWIFTWATER, Pa., Nov. 11 /PRNewswire/ -- Sanofi Pasteur, the
vaccines division of the sanofi-aventis Group (EURONEXT: SAN and
NYSE: SNY), announced today the final analyses of data from
clinical trials of the U.S. licensed Influenza A (H1N1) 2009
Monovalent Vaccine in adults and children.
To view the Multimedia News Release, go to: http://multivu.prnewswire.com/mnr/sanofi_pasteur/41122/
The data confirm the immunogenicity and safety profile of the
vaccine, with no serious vaccine-related adverse events reported
during the 42 days of follow-up in the two trials.
"These are extremely important data," said Wayne Pisano,
President and Chief Executive Officer of Sanofi Pasteur, "because
they once again make clear not only the immunogenicity of the
Influenza A (H1N1) 2009 Monovalent Vaccine manufactured by Sanofi
Pasteur, but also the fact that this vaccine has a safety profile
similar to that typically observed with seasonal influenza vaccine
in all age groups studied."
The trials confirm that one dose of Influenza A (H1N1) 2009
Monovalent Vaccine induces a robust antibody response in adults --
but two doses of vaccine are needed to assure a robust antibody
response in children 9 years of age and younger. The two-dose
regimen for these younger children is similar to the
recommendations for seasonal influenza immunization in this age
group.
About the Trial
The randomized, placebo-controlled, multicenter trials were
conducted by Sanofi Pasteur to determine the immunogenicity and
safety of the vaccine, given in two doses, with the second dose
administered 21 days following the first dose. Immunogenicity was
measured at day 21, just prior to administration of the second
dose, and again at day 42.
The adult trial was conducted in 849 individuals divided into
two age cohorts: 18 through 64 years of age; and 65 years of age
and older. Study participants in each age cohort were randomized to
four treatment groups. Three groups received a 0.5 mL injection of
non-adjuvanted vaccine formulated to contain 7.5, 15 or 30 mcg of
hemagglutinin (HA) antigen. The fourth group received a placebo
control (ClinicalTrials.gov registration number NCT00953524).
In the pediatric trial, 474 children were enrolled in two age
cohorts: 6 months through 35 months of age; and 3 years through 9
years of age. The trial evaluated two vaccine formulations, 7.5 mcg
and 15 mcg of HA antigen in each of two cohorts, with a third group
receiving a placebo (ClinicalTrials.gov registration number
NCT00952419).
At Day 42, 21 days following a second 7.5 mcg dose of Influenza
A (H1N1) 2009 Monovalent Vaccine, seroprotection (defined as an
antibody titer of 1:40 or greater) was achieved in 92 percent of
children 6 months through 35 months of age; and following a second
15 mcg dose of the vaccine, seroprotection was achieved in 99
percent of children 3 through 9 years of age, 99 percent of adults
18 through 64 years of age and in 95 percent of adults age 65 and
older.
Sanofi Pasteur previously reported interim data showing that an
immune response considered seroprotective was achieved following
one 15 mcg dose of the vaccine in 50 percent of children 6 months
through 35 months of age, 76 percent of children 3 through 9 years
of age, 98 percent of adults 18 through 64 years of age and 92
percent of adults age 65 and older.
A rise in antibody titers lower than 1:40 following vaccination
may minimize the occurrence of disease and its consequences but is
not considered seroprotective.
The data from these clinical trials provide additional
information to guide recommendations on the optimal dosage, number
of doses and schedule.
No serious vaccine-related adverse events were reported during
the trial. Adverse event monitoring will continue for six months
after administration of the second vaccine dose. Solicited systemic
and local reactions reported were similar to those observed in
other studies of seasonal trivalent inactivated influenza vaccine
administered to persons in comparable age groups.
About Influenza A (H1N1) 2009 Monovalent Vaccine
The U.S. licensed Influenza A (H1N1) 2009 Monovalent Vaccine
manufactured by Sanofi Pasteur is an inactivated influenza virus
vaccine indicated for active immunization of persons 6 months of
age and older against influenza disease caused by pandemic (H1N1)
2009 virus. Influenza A (H1N1) 2009 Monovalent Vaccine was licensed
by the U.S. Food and Drug Administration on September 15 as a
monovalent strain change to Sanofi Pasteur's licensed seasonal
influenza vaccine.
The Influenza A (H1N1) 2009 Monovalent Vaccine is manufactured
by the same process as Sanofi Pasteur's seasonal trivalent
influenza virus vaccine licensed in the U.S. Influenza A (H1N1)
2009 Monovalent Vaccine is formulated to contain 15 mcg
hemagglutinin (HA) of influenza A/California/07/2009 (H1N1) v-like
virus. Influenza A (H1N1) 2009 Monovalent Vaccine is licensed for
single-dose presentations in syringes and vials and in multi-dose
vials. There is no preservative used in the single-dose
presentations. Multi-dose vials contain a preservative.
Safety Information for Influenza A (H1N1) 2009 Monovalent
Vaccine
Influenza vaccine should not be administered to anyone with a
known severe hypersensitivity to egg proteins, any vaccine
component or life-threatening reactions after previous
administration of any influenza vaccine. Recurrence of
Guillain-Barre syndrome (GBS) has been temporally associated with
the administration of influenza vaccine. The decision to give
Influenza A (H1N1) 2009 Monovalent Vaccine to individuals who have
a prior history of GBS should be based on careful consideration of
the potential benefits and risks. Vaccination with Influenza A
(H1N1) 2009 Monovalent Vaccine may not protect all
individuals.
Before administering Influenza A (H1N1) 2009 Monovalent Vaccine,
please see full U.S. Prescribing Information at
www.vaccineplace.com/products.
About Influenza Vaccine Production at Sanofi Pasteur
Sanofi Pasteur operates influenza vaccine production facilities
in Val de Reuil, France and in Swiftwater, Pa. (U.S.). All Sanofi
Pasteur influenza vaccine facilities have been designed and built
to be able to switch from seasonal influenza vaccine production to
pandemic influenza vaccine production.
Sanofi Pasteur produces approximately 40 percent of the
influenza vaccines distributed worldwide and more than 45 percent
of the influenza vaccines distributed in the U.S. for the 2008-2009
influenza season. More information about Sanofi Pasteur's pandemic
preparedness efforts can be found at
www.pandemic.influenza.com.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company,
discovers, develops and distributes therapeutic solutions to
improve the lives of everyone. Sanofi-aventis is listed in Paris
(EURONEXT: SAN) and in New York (NYSE:SNY) .
Sanofi Pasteur, the vaccines division of the sanofi-aventis
Group, provided more than 1.6 billion doses of vaccine in 2008,
making it possible to immunize more than 500 million people across
the globe. A world leader in the vaccine industry, Sanofi Pasteur
offers the broadest range of vaccines protecting against 20
infectious diseases. The company's heritage, to create vaccines
that protect life, dates back more than a century. Sanofi Pasteur
is the largest company entirely dedicated to vaccines. Every day,
the company invests more than EUR 1 million in research and
development. For more information, please visit: http://www.sanofipasteur.com/ or
www.sanofipasteur.us.
Project Funding
This project has been funded with Federal funds from the Office
of the Assistant Secretary for Preparedness and Response,
Biomedical Advanced Research and Development Authority, under
Contract No. HHSO100200900121C. The views expressed do not
necessarily reflect the official policies of the Department of
Health and Human Services; nor does mention of trade names,
commercial practices or organizations imply endorsement by the U.S.
Government.
Forward Looking Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements are statements that are not
historical facts. These statements include financial projections
and estimates and their underlying assumptions, statements
regarding plans, objectives, intentions and expectations with
respect to future events, operations, products and services, and
statements regarding future performance. Forward-looking statements
are generally identified by the words "expects," "anticipates,"
"believes," "intends," "estimates," "plans" and similar
expressions. Although sanofi-aventis' management believes that the
expectations reflected in such forward-looking statements are
reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and
uncertainties, many of which are difficult to predict and generally
beyond the control of sanofi-aventis, that could cause actual
results and developments to differ materially from those expressed
in, or implied or projected by, the forward-looking information and
statements. These risks and uncertainties include those discussed
or identified in the public filings with the SEC and the AMF made
by sanofi-aventis, including those listed under "Risk Factors" and
"Cautionary Statement Regarding Forward-Looking Statements" in
sanofi-aventis' annual report on Form 20-F for the year ended
December 31, 2008. Other than as required by applicable law,
sanofi-aventis does not undertake any obligation to update or
revise any forward-looking information or statements.
Video: http://multivu.prnewswire.com/mnr/sanofi_pasteur/41122
Source: Sanofi Pasteur
CONTACT: Donna Cary, US Media Relations, +1-570-957-0717,
donna.cary@sanofipasteur.com
Web Site: http://www.sanofipasteur.com/
Posted: November 2009
