【正文】 271 34 % 21, 45 Cu lt u r e co n f ir m ed p n eu m o co ccal A O M IT T 467 322 32 % 19, 42 Finnish OM Study Efficacy for VaccineRelated Serotypes N u mbe r o f E p i s o d e s V a c c i n e E f f i c a c y F o l l o w up P e r i o d HBV P n c C R M E s t i mat e 9 5 % C I PP 84 41 51 % 2 7 , 67 A O M d u e t o v a c c i n e r e l a t e d s e r o t y p e s I T T 90 50 44 % 2 0 , 62 Finnish OM Study AOM due to Individual VaccineRelated Serotypes, (Intenttotreat) N u mb e r o f E p i s o d e s V a c c i n e E f f i c a c y A O M E p i s o d e d u e t o S e rot y p e HBV P n c C R M E s t i mat e 9 5 % C I 6A 48 23 52% 1 7 , 7 2 9N 9 2 78% 6 , 9 5 18B 1 2 101% 2 1 0 8 , 8 2 19A 28 22 21% 4 0 , 5 6 23A 4 1 75% 1 4 9 , 9 7 Finnish Otitis Media Study Efficacy for VaccineUnrelated Pneumococcal Serotypes N u mbe r o f E p i s o d e s V a c c i n e E f f i c a c y F o l l o w up P e r i o d HBV P n c C R M E s t i mat e 9 5 % C I PP 95 126 34 8 1 , 0 A O M d u e t o o t h e r t h a n v a c c i n e r e l a t e d s e r o t y p e s I T T 101 140 39 8 6 , 3 S e r o t y p e s 3 , 1 1 , 1 5 , 3 5 w e r e t h e m o st c o m m o n v a cci n e u n r e l a t e d s e r o t y p e s i d e n t i f i ed. Finnish Otitis Media Study Efficacy for Recurrent AOM * N u mbe r o f C h i l d r e n w i t h R e c u r r e n t A O M V a c c i n e E f f i c a c y F o l l o w up P e r i o d HBV P n c C R M E s t i mat e 9 5 % C I PP 149 123 16% 6 , 3 5 C h i l d r e n w i t h R e c u r r e n t A O M I T T 174 158 9% 1 2 , 2 7 ? A l l ca u s e s o f A O M c o n t r i b u t e t o R e cu r r e n t A O M d e f i n i t i o n . Finnish Otitis Media Study Efficacy for Other Planned Analyses N u mb e r o f E p i s o d e s V a c c i n e E f f i c a c y F o l l o w up P e ri o d HBV P n c C R M E s t i mat e ( 9 5 % C I ) PP 1267 1177 7 % 5 , 17 A O M w i t h M E F? I T T 1445 1390 4 % 7 , 14 PP 1345 1251 6 % 4 , 16 A O M reg a rd l e s s o f e t i o l o g y I T T 1532 1474 4 % 7 , 14 ? M E F = M i d d l e E a r F l u i d Finnish OM Study Efficacy for Nasopharyngeal Carriage of Vaccine Serotypes (per protocol) No. Chil dren % Carri age % Redu ction HBV P ncC RM HBV P ncC RM E stim ate 95 % CI 12 m os 809 801 17 % 9, 37 18 m os 797 787 41 % 23, 55 Finnish OM Study— Serum Geometric Mean Antibody Concentration (GMC) After 3rd and 4th Doses Serotype Post Dose 3 GMC (mcg/mL) Post Dose 4 GMC (mcg/mL) HBV N=52 PncCRM N=54 HBV N=54 PncCRM N=55 4 6B 9V 14 18C 19F 23F Finnish OM Study— Serum Antibody Concentrations (GMC) and SerotypeSpecific Efficacy G M C ( m cg / m L ) S ero t y p e S ero t y p e sp ec i f i c ef f i ca cy es t i m at e ( P er P r o t o co l ) P o st d o s e 3 P o st d o s e 4 4 49% 1. 70 2. 56 6B 84% 2. 00 9. 05 9V 54% 2. 48 3. 97 14 69% 6. 28 10 . 82 18C 58% 3. 55 6. 51 19F 25% 3. 28 4. 96 23F 59% 2. 51 6. 25 Finnish Otitis Media Study— Invasive Disease Due to Pneumococcus S t u d y g r o u p S er o t y p e Clin ica l s y n d r o m e A g e ( m o n t h s) P n cCRM 7 * Bact er emia 19 HBV 15 * 23F 19F Me n in g it is Me n in g it is Bact er emia 8 14 9 * N o n v a c c i n e s e r o t y p e s Finnish Otitis Media Study: Review Issues and Supplementary Analyses Finnish OM Study: Analysis of Covariates Efficacy Estimates Adjusted for Gender, AOM Prior to Enrollment, Gestational Age, Birth Weight, Daycare, Breastfeeding, and Household Smoking V a c c i n e E f f i c a c y ( 9 5 % C I ) O u t c o mes A n a l y ze d u n d e r I n t e n t to t rea t Un a d j u s t e d f o r C o v a ri a t e s A d j u s t e d f o r C o v a ri a t e s A O M d u e t o V a c c i n e S e roty p e s 54% ( 4 1 , 6 4 ) 54% ( 4 1 , 6 4 ) C u l t u r e c o n f i rm e d P n e u mo . A O M 32% ( 1 9 , 4 2 ) 32% ( 2 0 , 4 3 ) A O M R e g a rdl e s s o f E t i o l o g y 4% ( 7 , 1 4 ) 5% ( 6 , 1 4 ) Finnish OM Study: Example from the Data, Multiple Episodes Due to Same Serotype S u b j e c t I D V a c c i n e G ro u p C u l t u r e A g e a t A O M 23F 335 23F 347 1680 HBV 23F 355 23F 374 23F 462 23F 677 Finnish OM Study: Examples from the Data, Multiple Episodes Due to Same Serotype S u b j e c t I D V a c c i n e G r o u p C u l t u r e A O M A g e 1450 P n c C R M 23F 268 23F 344 23F 665 15 163 2241 P n c C R M 15 227 15 267 Finnish OM Study— Supplementary Analysis: Subsequent AOM Episodes due to Same Serotype Excluded, Vaccine Serotypes (PP) Num ber o f E pi sod es V acci ne E ff i cac y I ncl usi on / E xcl usi on of Mu l tipl e E pi sod es of S am e S erot y pe HBV P ncC RM E stim . 95 % CI P er Analy si s P l an 250 107 57 % 44, 67 E xcl ud e sub sequ en t epi sod e du e to s am e seroty pe 216 95 55 % 43, 65 Finnish OM Study— Supplementary Analysis: Subsequent AOM Episodes due to Same Serotype Excluded, All Pneumococcal Serotypes (Per Protocol) Num ber o f E pi sodes V acci ne E ff i cac y I ncl usi on/ E xcl usi on of Mu l tipl e E p