WYE Wyeth

COLLEGEVILLE, Pa., June 11 /PRNewswire-FirstCall/ -- New data from Phase 3 European clinical trials reinforce that Wyeth's (NYSE:WYE) investigational pneumococcal vaccine, Prevenar 13* (Pneumococcal Polysaccharide Conjugate Vaccine, 13-valent [Adsorbed]), has the potential to provide coverage against the 13 most prevalent serotypes associated with pneumococcal disease (PD), the leading cause of vaccine-preventable death in children younger than five worldwide. The Phase 3 data presented at the 27th Annual Meeting of the European Society for Pediatric Infectious Diseases (ESPID) come from seven core studies in the pediatric clinical trial program for Prevenar 13 which were conducted in France, Italy, Poland, Spain and the UK. Researchers also presented health economic models which estimated the potential public health and economic impact of Prevenar 13 -- if approved and incorporated into national immunization programs -- for the Netherlands, the UK, as well as Germany and the U.S. "Our investigational vaccine, Prevenar 13, builds on the scientific foundation of Prevenar and is designed to provide more comprehensive protection against pneumococcal disease," says Emilio A. Emini, Ph.D., Executive Vice President, Vaccines Research and Development, Wyeth Pharmaceuticals. "These new data indicate that Prevenar 13 has the potential to provide direct coverage of the 13 most common disease-causing serotypes, including 3, 6A and 19A, which have been increasing in prevalence in many regions around the world." Prevenar 13 includes the seven serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) in Prevenar* (Pneumococcal Polysaccharide Conjugated Vaccine, [Adsorbed]) -- the current global standard in PD prevention in infants and young children as well as six additional serotypes (1, 3, 5, 6A, 7F and 19A) associated with the greatest remaining burden of invasive disease. Both Prevenar 13 and Prevenar use CRM197 -- an immunological carrier protein with a 20-year history of use in pediatric vaccines. Phase 3 Data Results Data from the studies presented at ESPID indicate that Prevenar 13 is immunogenic for all serotypes and showed a safety profile similar to Prevenar. Among the study findings: -- In a study conducted in France, 613 children were randomized to receive either four doses of Prevenar or Prevenar 13 at 2, 3, 4 and 12 months, or three doses of Prevenar at 2, 3 and 4 months with a booster dose of Prevenar 13 or Prevenar at 12 months. Antibody response was measured at month 13. Both of the Prevenar 13 schedules induced a robust immune response for all 13 serotypes. -- In a study conducted in Italy, 606 healthy infants aged 3 months were randomized to receive Prevenar 13 or Prevenar along with Infanrix hexa(R) [GlaxoSmithKline], the combined diphtheria, tetanus, pertussis, hepatitis B, inactivated poliovirus, and Hib vaccine, at 3, 5, and 11 months of age. Assessment of functional antibody levels (serotype specific opsonphagocytic assay) one month after the infant series and after the booster dose showed that a high percentage of infants receiving Prevenar 13 had functional antibodies for all serotypes. Prevenar 13 did not affect responses to the concomitantly administered vaccine and showed a safety profile comparable to Prevenar. -- A study of 352 children in Poland assessed the safety and immunogenicity of Prevenar 13 in older children not previously immunized with Prevenar. Children were vaccinated with one of three different catch-up schedules currently recommended for Prevenar. These treatment schedules included the following: 1) two doses of Prevenar 13 at age 7 to