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Positive Phase III Results for Pneumococcal Vaccine, Prevenar 13, in Adults
All primary and secondary endpoints met (Apr. 28)
Positive results have been reported from a phase III study that investigated the immunogenicity, tolerability, and safety of Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]; Pfizer) in adults 18 to 49 years of age. The study met all primary and secondary objectives and provides the clinical foundation for regulatory submission in the U.S. to seek expansion of the use of Prevenar 13 in this population.
The new findings were presented at the 23rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), held in Berlin, Germany.
The 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 1 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.
The vaccine 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.
Pneumococcal disease is a group of illnesses caused by the bacterium Streptococcus pneumoniae, also known as pneumococcus. The disease can affect people of all ages, although older adults, young children, and individuals with certain chronic medical conditions are at increased risk. The illness is associated with significant morbidity and mortality. Invasive manifestations of the disease include bacteremia and meningitis.
In the U.S., Prevenar 13 is approved for children 6 weeks through 17 years of age 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), and for children 6 weeks through 5 years of age for the prevention of otitis media caused by seven of the 13 strains (4, 6B, 9V, 14, 18C, 19F, and 23F). The vaccine 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.
Source: Pfizer; April 28, 2013.