New Phase 3 Data Continue to Indicate that Wyeth's Investigational 13-valent Vaccine Has the Potential to Broaden Coverage Against Pneumococc...(ted with the greatest remaining burden o...)

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 <12 months with a booster at age 12-16 months; 2) two doses of Prevenar 13 at age 12 to
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