This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

Pfizer Announces Top-Line Results Of Prevenar 13® Phase 3 Trial In Adults 18 To 49 Years Of Age

Stocks in this article: PFE

About the Study

Study 6115A1-004 is a pivotal, Phase 3, multi-center trial designed to compare the immunogenicity, tolerability and safety of Prevenar 13 and the currently licensed nonconjugated pneumococcal polysaccharide vaccine (PPSV) in 740 adults 60 to 64 years of age who were naïve to PPSV, using a randomized, modified double-blind design. The study also assessed immunogenicity, tolerability and safety of Prevenar 13 administered open-label to 370 adults 50 to 59 years of age and compared to adults 60 to 64 years of age. Additionally, 900 healthy adults 18 to 49 years of age (patients with stable chronic risk conditions were eligible for inclusion) were assessed. These participants received open-label Prevenar 13 to assess the immune response to Prevenar 13 in that younger age group and to compare immune responses with participants 60 to 64 years of age. Serotype specific anti-pneumococcal functional antibodies were measured for all 18 to 49 year old participants prior to vaccination, at one month following vaccination and again at one year following vaccination with Prevenar 13.

A detailed analysis of this immunogenicity and safety study data will be submitted for future publication. Data concerning the 50 years of age and older cohorts were previously presented at the 21st European Congress of Clinical Microbiology and Infectious Diseases in 2011.

About Prevenar 13 and Conjugate Technology

Prevenar 13 uses Company-pioneered conjugate technology that links pneumococcal polysaccharide sugar chains found on the surface of each bacterial serotype with a carrier protein. Prevenar 13 uses the carrier protein CRM 197, which has more than 20 years of clinical and commercial use in vaccines.

Pneumococcal Disease

Pneumococcal disease (PD) is a group of illnesses caused by the bacterium Streptococcus pneumoniae ( S. pneumoniae), 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. Non-invasive PD includes non-bacteremic pneumococcal pneumonia (acute lower respiratory infection that affects the lungs), which is the most common form of PD in adults, as well as sinusitis (upper respiratory tract infection) and acute otitis media (middle ear infection, most often found in children). Invasive manifestations of the disease include bacteremic pneumonia (lung infection with bacteria in the blood), bacteremia (bacteria in the blood) and meningitis (infection of the tissues surrounding the brain and spinal cord).

EU Indications for Prevenar 13

In the European Union, Prevenar 13 is indicated for active immunization for the prevention of invasive pneumococcal disease caused by Streptococcus pneumoniae in adults aged 50 years and older caused by 13 Streptococcus pneumoniae serotypes. The vaccine is also indicated for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks to 5 years of age.

For a global summary of Prevenar 13 characteristics (SmPC), please click here http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001104/WC500057247.pdf

U.S. Indications for Prevnar 13

  • Prevnar 13 is a vaccine indicated for adults 50 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). This indication is based upon immune responses to the vaccine
  • In children 6 weeks through 5 years of age, Prevnar 13 is indicated for the prevention of invasive disease caused by these same strains, and for the prevention of ear infection caused by 7 of the 13 strains
  • Prevnar 13 is not 100% effective and will only help protect against the 13 strains included in the vaccine
  • Effectiveness when given less than 5 years after a pneumococcal polysaccharide vaccine is not known

Important Safety Information

  • Prevnar 13 should not be given to anyone with a history of severe allergic reaction to any component of Prevnar 13 or any diphtheria toxoid–containing vaccine
  • Children and adults with weakened immune systems (e.g., HIV infection, leukemia) may have a reduced immune response
  • In adults, the common side effects were pain, redness, or swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, chills, or rash
  • In adults, immune responses to Prevnar 13 were reduced when given with injected seasonal flu vaccine
  • A temporary pause of breathing following vaccination has been observed in some infants born prematurely
  • The most commonly reported serious adverse events in children were bronchiolitis (an infection of the lungs) (0.9%), gastroenteritis (inflammation of the stomach and small intestine) (0.9%), and pneumonia (0.9%)
  • In infants and toddlers, the most common side effects were tenderness, redness or swelling at the injection site, irritability, decreased appetite, decreased or increased sleep, and fever
  • Ask your health care provider about the risks and benefits of Prevnar 13. Only a health care provider can decide if Prevnar 13 is right for you

For the full prescribing information for Prevnar 13, please click here http://www.pfizer.com/products/#prevnar13

Pfizer Inc.: Working together for a healthier world®

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer 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 the world’s leading biopharmaceutical company, we also 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 about our commitments, please visit us at www.pfizer.com.

DISCLOSURE NOTICE: The information contained in this release is as of October 4, 2012. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information that involves substantial risks and uncertainties regarding a potential indication for Prevenar 13 for adults 18 to 49 years of age, including its potential benefits. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by the European Commission and by regulatory authorities in other jurisdictions in which applications may be filed regarding whether and when to approve this potential indication as well as their decisions regarding labeling and other matters that could its affect the availability and commercial potential; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and in its reports on Form 10-Q and Form 8-K.

*Prevenar 13 is referred to as Prevnar 13 in the United States.

2 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Jim Cramer and Stephanie Link reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

Jim Cramer's protégé, David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!

Markets

DOW 17,444.11 +56.90 0.33%
S&P 500 2,031.10 +1.55 0.08%
NASDAQ 4,705.1710 +23.6740 0.51%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs