PEDIATRICS Vol. 81 No. 6 June 1988, pp. 908-911
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Haemophilus influenzae Type b Conjugate Vaccine

Committee on Infectious Diseases

On Dec 22, 1987, the first conjugate vaccine was licensed by the FDA for the prevention of infections due to Haemophilus influenzae type b. This vaccine is a conjugate of H influenzae type b capsular polysaccharide and diphtheria toxoid and is officially designated as Haemophilus b conjugate vaccine (diphtheria toxoid-conjugate). The purpose of this statement is to provide background information, perspective, and recommendations for the use of this product.

BACKGROUND

H influenzae type b is a major cause of serious infections in infants and children, about 30% of which occur in children 18 months of age and older.1,2 American licensure of the "first-generation" vaccines, the Haemophilus b polysaccharide vaccines or "plain" capsular polysaccharide vaccines (often referred to as PRP), was based on a field trial conducted in Finland.3 In this study which started in 1975, 48,977 children 3 to 71 months of age received a polysaccharide vaccine similar to those that were later licensed in the United States. Protection was correlated with the production of an anticapsular antibody concentration that exceeded 1.0 µg/mL in serum obtained 3 weeks after immunization. In children immunized at 18 to 71 months of age, the efficacy was 90% (95% confidence interval, 55% to 98%).2,3 Among those immunized at 18 to 23 months of age, the small number of cases in the vaccinees and the control group precluded a definitive conclusion about vaccine efficacy. In 8,453 children immunized at 2 years of age (24 to 35 months), the efficacy was 80% (95% confidence interval, 7% to 94%).4




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A. D. Racine, T. J. Joyce, W. Li, and M. A. Chiasson
Recent Declines in New York City Infant Mortality Rates
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