About the Study
Vaccine safety, tolerability and immunogenicity were evaluated in the Phase 3, open-label, single-arm trial of 331 adults with HIV aged 18 years or older. All participants had CD4 cell counts of 200 cells/mm
or higher and had previously received one or more doses of PPSV. Subjects were stratified equally into two groups, those previously vaccinated with one dose of PPSV and those previously vaccinated with two or more doses of PPSV. Participants received three doses of Prevnar 13 at six months intervals. Local and systemic reactions and adverse events were collected.
Pneumococcal disease (PD) 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).
U.S. Indication for Prevnar 13
Important Safety Information
- Prevnar 13 is a vaccine approved for the prevention of invasive disease caused by 13 S. pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in children 6 weeks through 17 years of age, and in children 6 weeks through 5 years for the prevention of otitis media caused by 7 of the 13 strains (4, 6B, 9V, 14, 18C, 19F, and 23F)
- Based upon immune responses to the vaccine, Prevnar 13 is also approved for adults 50 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by the 13 vaccine 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
- 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
- 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
- In adults, immune responses to Prevnar 13 were reduced when given with injected seasonal flu vaccine
- 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
- 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 your child
For the full prescribing information for Prevnar 13, please click here
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The information contained in this release is as of March 4, 2013. 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 planned regulatory submissions to include data on HIV-infected immunocompromised adults in the Prevnar 13 label, including its potential benefits. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; whether and when submissions may be made to regulatory authorities for this potential label update for Prevnar 13; decisions by the U.S. Food and Drug Administration, the European Medicines Agency and regulatory authorities in other jurisdictions in which submissions may be made regarding whether and when to approve this potential label update for Prevnar 13 as well as their other decisions regarding labeling and other matters that could affect its 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, 2012 and in its reports on Form 10-Q and Form 8-K.
*Prevnar 13 is referred to as Prevenar 13 in most markets outside the United States.