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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

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Kaiser Permanente Efficacy Trial Study Design

• Randomized, double-blind, controlled
• 7VPnC vs Control (MnCC conjugate) 11
• 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

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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

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Kaiser Permanente Efficacy Trial Otitis Media
Primary Endpoint

• Primary endpoint All OM episodes
• Episode defined as a clinic visit for OM with no
  prior visit for OM within 21 days

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Kaiser Permanente Efficacy Trial Otitis 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
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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
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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

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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
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Otitis Media Events
? 3 episodes within 6 months or ? 4 episodes
within 12 months
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First Procedure
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Overall Number of Oral Antibiotic
Prescriptions As of April 20, 1999
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Otitis Media Conclusions

• Prevnar significantly reduced the risk of otitis
  media
• Efficacy was higher for frequent otitis and for
  ear tube placement

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Thank you