# Presentation: 790474

## 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**

## 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 12-15 months**
**Given concomitantly with routine childhood vaccines**
**Trial began in October 1995 and was unblinded in April 1999**

## 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**

## Kaiser Permanente Efficacy Trial Otitis Media Primary Endpoint

**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**

## Kaiser Permanente Efficacy Trial Otitis Media 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****  **

## Otitis Media:  A Frame of Reference

**Episodes**
**OM**

**Bacterial**
**OM**

**Pneumococcal**
**OM**

**Vaccine**
**Serotype**
**OM**

**Otitis Media:  A Frame of Reference**

**50 - 60%**

**20 - 40%**

**75 - 85%**

**Overall potential impact = 8 - 20% if 100% efficacy**

## 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**

## Study Population for 

**Otitis Media**

** **

**April 1998 and  April 1999**

**April 1998 Database**

**April 1999 Database**

**Number**

**of children**

**       ****7vPnC           Control**

**Number **

**of children**

**     ****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**

**per-protocol follow-up**

**2,735 **

**2,770  **

**7,266**** **

**7,320 **

**Age **

**>**

** ****3 yrs at end of**

**per-protocol follow-up**

**0**

**0**

**2,327**

**2,319 **

## Otitis Media Events

***  ******** 3 episodes within 6 months or ******** 4 episodes within 12 months**

## Slide 10

## Slide 11

## *First Procedure

***First Procedure**

## Slide 13

## Overall Number of Oral Antibiotic Prescriptions

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

## Otitis Media Conclusions

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

## Thank you