Phase 3 Study Update of Prevnar 13 for Pneumococcal Vaccination in Older Children and Adolescents

Pfizer announced that data from a Phase 3 study of Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) met all study endpoints, showing immunogenicity and establishing a safety profile in children and adolescents aged 5–17 years.

Vaccine immunogenicity and safety were evaluated in the open-label trial of 598 healthy children, including children aged 5–10 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 10–17 years.

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.

In children 6 weeks through 5 years of age (prior to the 6th birthday), Prevnar 13 is indicated for: active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae, as well as active immunization for the prevention of otitis media caused by Streptococcus pneumoniae. In adults ≥50 years of age, Prevnar 13 is indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae.

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