(ATP cohort) Type or cause of AOM Vaccine efficacy Clinical AOM episodes regardless of 33.6 % etiology (95% CI: 20.8; 44.3) AOM episodes due to any 51.5% pneumococcal serotype (95% CI: 36.8;62.9) AOM episodes due to pneumococcal 57.6% serotypes covered by the 11Pn-PD (95% CI: 41.4;69.3) vaccine AOM episodes due to pneumococcal 67.9% serotypes covered by Synflorix (95% CI: 53.0;78.1) AOM episodes due to vaccine related 65.5% pneumococcal serotypes (95 % CI: 22.4;84.7) AOM episodes caused by Hi (including 35.6% NTHi) (95% CI: 3.8; 57.0) AOM episodes caused by NTHi only 35.3% (95% CI: 1.8;57.4) No increase in the incidence of AOM due to other bacterial pathogens was observed. The incidence of recurrent AOM (≥ 3 episodes in 6 months or 4 in 12 months) was reduced ≥ by 56% (95% CI:-1.9; 80.7) and ventilation tube placement by 60.3% (95% CI:-6.7; 87.5). Based on immunological bridging of the functional vaccine response of Synflorix with the formulation used within POET, it is expected that Synflorix provides similar protective efficacy against pneumococcal AOM. In all studies, between 98.3% and 100% of infants receiving Synflorix vaccine were seropositive (≥100 EL.U/ml) for antibodies against Protein
(ATP cohort) Type or cause of AOM Vaccine efficacy Clinical AOM episodes regardless of etiology 33.6 % (95% CI: 20.8; 44.3) AOM episodes due to any pneumococcal serotype 51.5% (95% CI: 36.8;62.9) AOM episodes due to pneumococcal serotypes covered by the 11Pn-PD vaccine 57.6% (95% CI: 41.4;69.3) AOM episodes due to pneumococcal serotypes covered by Synflorix 67.9% (95% CI: 53.0;78.1) AOM episodes due to vaccine related pneumococcal serotypes 65.5% (95 % CI: 22.4;84.7) AOM episodes caused by Hi (including NTHi) 35.6% (95% CI: 3.8; 57.0) AOM episodes caused by NTHi only 35.3% (95% CI: 1.8;57.4) No increase in the incidence of AOM due to other bacterial pathogens was observed. The incidence of recurrent AOM (≥ 3 episodes in 6 months or ≥ 4 in 12 months) was reduced by 56% (95% CI:-1.9; 80.7) and ventilation tube placement by 60.3% (95% CI:-6.7; 87.5). Based on immunological bridging of the functional vaccine response of Synflorix with the formulation used within POET, it is expected that Synflorix provides similar protective efficacy against pneumococcal AOM. In all studies, between 98.3% and 100% of infants receiving Synflorix vaccine were seropositive (≥100 EL.U/ml) for antibodies against Protein