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RANDOMIZED, CONTROLLED TRIAL EFFICACY OF PNEUMOCOCCAL CONJUGATE VACCINE AGAINST OTITIS MEDIA AMONG NAVAJO AND WHITE MOUNTAIN APACHE INFANTS

O’Brien, Katherine L. MD, MPH; David, Angeline B. MHS; Chandran, Aruna MD, MPH; Moulton, Lawrence H. PhD; Reid, Raymond MD, MPH; Weatherholtz, Robert BS; Santosham, Mathuram MD, MPH

Pediatric Infectious Disease Journal:
doi: 10.1097/INF.0b013e318159228f
Brief Reports
Abstract

We report the phase III trial efficacy of 7-valent pneumococcal conjugate vaccine against clinical and culture proven otitis media (OM) among Navajo and White Mountain Apache infants. Efficacy was −0.4% (95% CI: −19.4 to 15.6) for clinically-diagnosed OM, 5.1% (95% CI: −51.5 to 40.6) for severe OM, and 64% (95% CI: −34% to 90%) for vaccine serotype pneumococcal OM suggesting that this vaccine is efficacious for pneumococcal OM in this high risk population.

Author Information

From the Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.

Accepted for publication August 22, 2007.

Financial support for the American Indian PnCRM7 Efficacy Trial was from Wyeth Vaccines, National Institutes of Health, World Health Organization, The National Vaccine Program Office, and the Centers for Disease Control and Prevention.

Participation in Wyeth Scientific Advisory Boards (to KLOB, and MS), receipt of research funding from Wyeth Vaccines (to KLOB, LHM, RR, RW, and MS).

The opinions expressed in this paper are those of the authors and do not necessarily reflect the views of the Indian Health Service.

Address for correspondence: Katherine L. O’Brien, MD, MPH, 621 N. Washington Street, Baltimore, MD 21205. E-mail: klobrien@jhsph.edu.

© 2008 Lippincott Williams & Wilkins, Inc.