1 Otitis Media Results from the Kaiser Permanente Efficacy Trial Steven Black, MD, Henry Shinefield, MD and Bruce Fireman, MS Kaiser Permanente Vaccine Study Center Oakland, California

2 Kaiser Permanente Efficacy Trial Study Design Randomized, double-blind, controlled –7VPnC vs Control (MnCC conjugate) 1:1 Immunizations at 2, 4, & 6 months of age with a booster months –Given concomitantly with routine childhood vaccines Trial began in October 1995 and was unblinded in April 1999

3 Kaiser Permanente Efficacy Trial Otitis Media Outcomes Otitis media diagnoses captured as part of routine care for visits to pediatricians, emergency physicians and specialists; no cross training of observers Surgery for ear tube placement captured as part of hospital database Spontaneously draining ears cultured

4 Primary endpoint: All OM episodes Episode defined as a clinic visit for OM with no prior visit for OM within 21 days Kaiser Permanente Efficacy Trial Otitis Media Primary Endpoint

5 Secondary endpoints: –First otitis episode –Frequent otitis media* –Tympanostomy tube placement –Spontaneously ruptured ear drum due to vaccine serotypes –All clinic visits for otitis media Kaiser Permanente Efficacy Trial Otitis Media Secondary Endpoints *  3 episodes within 6 months or  4 episodes within 12 months

6 Clinical Episodes OM Bacterial OM Pneumococcal OM Vaccine Serotype OM Otitis Media: A Frame of Reference % % % Overall potential impact = % if 100% efficacy

7 Follow-up for Otitis Media OM data cutoff for original submission April 30, 1998 Blinded immunization per protocol continued Study nurses, physicians and parents unblinded April 20, 1999 – 37,868 children randomized

8 Study Population for Otitis Media April 1998 and April 1999 April 1998 DatabaseApril 1999 Database Number of children 7vPnC Control Number of children 7vPnC Control Total Enrolled17,06617,08018,92618,942 Booster: Dose 49,0479,12216,12216,152 Age> 2 yrs at end of per-protocol follow-up 2,7352,7707,2667,320 Age> 3 yrs at end of per-protocol follow-up 002,3272,319

9 Otitis Media Events *  3 episodes within 6 months or  4 episodes within 12 months

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12 *First Procedure

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14 Overall Number of Oral Antibiotic Prescriptions As of April 20, 1999

15 Otitis Media Conclusions Prevnar significantly reduced the risk of otitis media Efficacy was higher for frequent otitis and for ear tube placement

16 Thank you