Pfizer Presents Phase 3 Safety And Immunogenicity Data On Prevenar 13 In Adults Aged 18 To 49 Years
NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. (NYSE:PFE) presented today the results from a Phase 3 study
investigating immunogenicity, tolerability and safety of Prevenar 13*
(Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) in
adults 18 to 49 years of age. The study met all primary and secondary
objectives and provides the clinical foundation for the Companys
regulatory submission in the European Union (EU) and planned regulatory
submissions in the United States (U.S.) and other countries around the
world to seek expansion of These results were presented at the 23
European Congress of Clinical Microbiology and Infectious Diseases
(ECCMID) in Berlin, Germany.
Data from this study showed that Prevenar 13 was at least as immunogenic
in adults 18 to 49 years of age as it is in adults 60 to 64 years of
age, as measured one month after vaccination; for adults 18 to 49 years
of age, functional antibody responses to all 13 serotypes included in
the vaccine were non-inferior to responses in adults 60 to 64 years of
age.In the study, Prevenar 13 showed a favorable safety
profile and was generally well tolerated. Pain at the injection site was
the most frequently observed local reaction. Muscle pain, headache and
fatigue were the most common systemic events.
This important analysis shows the immunogenicity and safety profile
following vaccination with Prevenar 13 in adults aged 18 to 49 years.
This vaccine has the potential to help prevent pneumococcal disease
caused by the serotypes contained in the
vaccine, said lead investigator Dr. Kristina Bryant, associate
professor of Pediatrics at the University of Louisville.
Currently, Prevenar 13, or Prevnar 13 as it is called in the U.S.,
Canada and Taiwan, is approved in more than 120 countries worldwide for
use in infants and young children and in more than 80 countries for use
in adults 50 years of age and older.
Pfizer is committed to developing vaccines with the goal of preventing
serious disease through every stage of life, said Dr. William Gruber,
senior vice president, Pfizer Vaccine Clinical Research and Development.
We continue to further investigate the use of Prevenar 13 with the aim
of broadening prevention efforts to additional populations.
This study, titled Immunogenicity and safety of a 13-valent
pneumococcal conjugate vaccine in adults 18-49 years, naïve to 23-valent
pneumococcal polysaccharide vaccine, was presented as an ePoster during
the session : Serotypes and
Vaccination, at ECCMID 2013 on April 28 at 1:30 p.m. CEST.
Pneumococcal Disease is a group of illnesses caused by the bacterium (, also known as pneumococcus. It
can affect people of all ages, although older adults, young children and
individuals with certain chronic medical conditions are at heightened
risk.PD is associated with significant morbidity and
mortality.Invasive manifestations of the disease include
bacteremia (bacteria in the blood) and meningitis (infection of the
tissues surrounding the brain and spinal cord).
Prevenar 13 is approved in the EU for the prevention of invasive
disease, pneumonia and acute otitis media caused by
serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in
children and adolescents aged 6 weeks to 17 years. It is also approved
in the EU for the prevention of invasive disease caused by 13 serotypes (single dose) in adults 50 years and older.
For the full prescribing information for Prevenar 13, please click here http://www.pfizer.com/products/#prevnar13.
At Pfizer, we apply science and our global resources to bring therapies
to people that extend and significantly improve their lives. We strive
to set the standard for quality, safety and value in the discovery,
development and manufacture of health care products. Our global
portfolio includes medicines and vaccines as well as many of the world's
best-known consumer health care products. Every day, Pfizer colleagues
work across developed and emerging markets to advance wellness,
prevention, treatments and cures that challenge the most feared diseases
of our time. Consistent with our responsibility as one of the world's
premier innovative biopharmaceutical companies, we collaborate with
health care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world. For
more than 150 years, Pfizer has worked to make a difference for all who
rely on us. To learn more, please visit us at www.pfizer.com.
*Trademark. Prevenar 13 is referred to as Prevnar 13 in the United
Pfizer Inc.Media:Victoria Davis, +1 484-865-5194(o)orInvestors:Suzanne
Harnett, +1 212-733-8009(o)
Source: Pfizer Inc.