Pfizer Inc. has reported the data from a phase III study of Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) to meet all study endpoints, showing immunogenicity and establishing a safety profile in children and adolescents aged 5 through 17 years.
These data, which are being presented today during the 8th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in Iguacu Falls, Brazil, will support planned regulatory submissions seeking to expand the Prevnar 13 label in the United States, the European Union, and other countries around the world.
Vaccine immunogenicity and safety were evaluated in the phase III, open-label trial of 598 healthy children, including children aged 5 to 10 years who had previously been vaccinated for the prevention of invasive pneumococcal disease with Prevnar (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), the original version of the vaccine, and vaccine-naïve children and adolescents aged 10 through 17 years.
“As a global leader in pneumococcal disease prevention, we are excited about the potential to further define the clinical utility of Prevnar 13 with the aim of seeking to broaden prevention efforts to additional age groups,” says Emilio Emini, PhD, chief scientific officer, Vaccine Research, Pfizer Inc. “While pneumococcal disease most often strikes younger children, older children and adolescents who have certain medical conditions are also at heightened risk for contracting the disease.”
The primary objective of this study was to assess the pneumococcal immune responses induced by Prevnar 13 when measured one month after vaccination in each of the age groups. The safety objective of the study was to evaluate the safety profile of Prevnar 13 as measured by the incidence rates of local reactions, systemic events, and adverse events. The most common adverse events after vaccination were cough, headache, vomiting, fever, sore throat, influenza and sinusitis.
The data (late-breaker poster #881) will be presented at ISPPD during the daily poster viewing sessions.
Prevnar 13, which is based on the scientific foundation and proven experience of Prevnar, offers the broadest coverage of any pneumococcal conjugate vaccine. Prevnar 13 was first introduced for use in infants and young children in December 2009 in Europe and is now approved for such use in more than 110 countries worldwide. The most widely used pneumococcal conjugate vaccine in the world, Prevnar 13 is part of the routine immunization program in more than 50 countries.
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 young children, older adults, 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 pneumonia, otitis media and sinusitis (upper respiratory tract infection) and invasive manifestations of the disease include bacteremia (bacterial infections of the blood) and meningitis (inflammation of the membrane surrounding the spinal cord and brain).
Prevnar 13 is a vaccine approved for use in children 6 weeks through 5 years for prevention of invasive disease (caused by the 13 strains of Streptococcus pneumoniae included in the vaccine) and ear infections (caused by 7 of the 13 strains). Based upon immune responses to the vaccine, Prevnar 13 is also approved for adults 50 years and older for the prevention of pneumococcal pneumonia and invasive disease caused by the 13 vaccine strains.
It 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. The common side effects in adults, were pain, redness, or swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, chills, or rash.
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