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Otitis Media Results from the Kaiser Permanente Efficacy Trial
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  1. Otitis MediaResults 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 TrialStudy Design • Randomized, double-blind, controlled • 7VPnC vs Control (MnCC conjugate) 1:1 • Immunizations at 2, 4, & 6 months of age with a booster 12-15 months • Given concomitantly with routine childhood vaccines • Trial began in October 1995 and was unblinded in April 1999

  3. Kaiser Permanente Efficacy TrialOtitis 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. Kaiser Permanente Efficacy TrialOtitis Media Primary Endpoint • Primary endpoint:All OM episodes • Episode defined as aclinic visit for OM with no prior visit for OM within 21 days

  5. Kaiser Permanente Efficacy TrialOtitis Media Secondary Endpoints • 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 *  3 episodes within 6 months or  4 episodes within 12 months

  6. Otitis Media: A Frame of Reference Clinical Episodes OM 50 - 60% Bacterial OM Overall potential impact = 8 - 20% if 100% efficacy 20 - 40% Pneumococcal OM 75 - 85% Vaccine Serotype OM

  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. Otitis Media Study Population for April 1998 and April 1999 April 1998 Database April 1999 Database Number Number of children of children 7vPnC Control 7vPnC Control Total Enrolled 17,066 17,080 18,926 18,942 Booster: Dose 4 9,047 9,122 16,122 16,152 Age > 2 yrs at end of 2,735 2,770 7,266 7,320 per-protocol follow-up Age > 3 yrs at end of 0 0 2,327 2,319 per-protocol follow-up

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

  10. *First Procedure

  11. Overall Number of Oral Antibiotic Prescriptions As of April 20, 1999

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

  13. Thank you