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Previous Volume 349:1341-1348 October 2, 2003 Number 14 Next

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ABSTRACT

Background Acute respiratory tract infections caused by Streptococcus pneumoniae are a leading cause of morbidity and mortality in young children. We evaluated the efficacy of a 9-valent pneumococcal conjugate vaccine in a randomized, double-blind study in Soweto, South Africa.

Methods At 6, 10, and 14 weeks of age, 19,922 children received the 9-valent pneumococcal polysaccharide vaccine conjugated to a noncatalytic cross-reacting mutant of diphtheria toxin (CRM197), and 19,914 received placebo. All children received Haemophilus influenzae type b conjugate vaccine. Efficacy and safety were analyzed according to the intention-to-treat principle.

Results Among children without human immunodeficiency virus (HIV) infection, the vaccine reduced the incidence of a first episode of invasive pneumococcal disease due to serotypes included in the vaccine by 83 percent (95 percent confidence interval, 39 to 97; 17 cases among controls and 3 among vaccine recipients). Among HIV-infected children, the efficacy was 65 percent (95 percent confidence interval, 24 to 86; 26 and 9 cases, respectively). Among children without HIV infection, the vaccine reduced the incidence of first episodes of radiologically confirmed alveolar consolidation by 20 percent (95 percent confidence interval, 2 to 35; 212 cases in the control group and 169 in the vaccinated group) in the intention-to-treat analysis and by 25 percent (95 percent confidence interval, 4 to 41; 158 and 119 cases, respectively) in the per-protocol analysis (i.e., among fully vaccinated children). The incidence of invasive pneumococcal disease caused by penicillin-resistant strains was reduced by 67 percent (95 percent confidence interval, 19 to 88; 21 cases in the control group and 7 in the vaccinated group), and that caused by strains resistant to trimethoprim–sulfamethoxazole was reduced by 56 percent (95 percent confidence interval, 16 to 78; 32 and 14 cases, respectively).

Conclusions Vaccination with a 9-valent pneumococcal conjugate vaccine reduced the incidence of radiologically confirmed pneumonia. The vaccine also reduced the incidence of vaccine-serotype and antibiotic-resistant invasive pneumococcal disease among children with and those without HIV infection.

Source Information

From the Medical Research Council, University of the Witwatersrand, National Institute for Communicable Diseases, Respiratory and Meningeal Pathogens Research Unit, Johannesburg, South Africa (K.P.K., S.A.M., R.E.H., N.M.); the Department of International Health, Rollins School of Public Health, and Division of Infectious Diseases, School of Medicine, Emory University, Atlanta (K.P.K.); Wyeth, Pearl River, N.Y. (R.K.); and Johns Hopkins University Bloomberg School of Public Health, Baltimore (N.P.).

Address reprint requests to Dr. Klugman at Emory University, 1518 Clifton Rd., #764, Atlanta, GA 30322, or at kklugma{at}sph.emory.edu.

Full Text of this Article

Related Letters:

Pneumococcal Conjugate Vaccine in Children
Davis R. L., Fireman B., Shinefield H. R., Klugman K. P., Madhi S. A., Kohberger R.
Extract | Full Text | PDF  
N Engl J Med 2004; 350:84-85, Jan 1, 2004. Correspondence

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