articleNew England Journal of MedicineOct 1, 2003BRONZE OA

A Trial of a 9-Valent Pneumococcal Conjugate Vaccine in Children with and Those without HIV Infection

Emory University · University of the Witwatersrand · +4 more institutions

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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.

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