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Previous Volume 344:403-409 February 8, 2001 Number 6 Next

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ABSTRACT

Background Ear infections are a common cause of illness during the first two years of life. New conjugate vaccines may be able to prevent a substantial portion of cases of acute otitis media caused by Streptococcus pneumoniae.

Methods We enrolled 1662 infants in a randomized, double-blind efficacy trial of a heptavalent pneumococcal polysaccharide conjugate vaccine in which the carrier protein is the nontoxic diphtheria-toxin analogue CRM197. The children received either the study vaccine or a hepatitis B vaccine as a control at 2, 4, 6, and 12 months of age. The clinical diagnosis of acute otitis media was based on predefined criteria, and the bacteriologic diagnosis was based on a culture of middle-ear fluid obtained by myringotomy.

Results Of the children who were enrolled, 95.1 percent completed the trial. With the pneumococcal vaccine, there were more local reactions than with the hepatitis B vaccine but fewer than with the combined whole-cell diphtheria–tetanus–pertussis and Haemophilus influenzae type b vaccine that was administered simultaneously. There were 2596 episodes of acute otitis media during the follow-up period between 6.5 and 24 months of age. The vaccine reduced the number of episodes of acute otitis media from any cause by 6 percent (95 percent confidence interval, –4 to 16 percent [the negative number indicates a possible increase in the number of episodes]), culture-confirmed pneumococcal episodes by 34 percent (95 percent confidence interval, 21 to 45 percent), and the number of episodes due to the serotypes contained in the vaccine by 57 percent (95 percent confidence interval, 44 to 67 percent). The number of episodes attributed to serotypes that are cross-reactive with those in the vaccine was reduced by 51 percent, whereas the number of episodes due to all other serotypes increased by 33 percent.

Conclusions The heptavalent pneumococcal polysaccharide–CRM197 conjugate vaccine is safe and efficacious in the prevention of acute otitis media caused by the serotypes included in the vaccine.

Source Information

From the National Public Health Institute, Helsinki, Finland (J.E., T.K., A.P., J.J., J.H., E.H., A.T., H.K., P.H.M.); Helsinki University Central Hospital, Helsinki, Finland (P.K.); and Wyeth Lederle Vaccines, Pearl River, N.Y. (R.K., G.S.). Other authors were Stephen Lockhart, D.M., Wyeth Lederle Vaccines, Berkshire, United Kingdom; and Mervi Eerola, Ph.D., National Public Health Institute, Helsinki, Finland.

Address reprint requests to Dr. Kilpi at the National Public Health Institute, 00300 Helsinki, Finland, or at terhi.kilpi{at}ktl.fi.

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• Saeland, E., Vidarsson, G., Leusen, J. H. W., van Garderen, E., Nahm, M. H., Vile-Weekhout, H., Walraven, V., Stemerding, A. M., Verbeek, J. S., Rijkers, G. T., Kuis, W., Sanders, E. A. M., van de Winkel, J. G. J. (2003). Central Role of Complement in Passive Protection by Human IgG1 and IgG2 Anti-pneumococcal Antibodies in Mice. J. Immunol. 170: 6158-6164 [Abstract] [Full Text]  
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• Jakobsen, H., Sigurdsson, V. D., Sigurdardottir, S., Schulz, D., Jonsdottir, I. (2003). Pneumococcal Serotype 19F Conjugate Vaccine Induces Cross-Protective Immunity to Serotype 19A in a Murine Pneumococcal Pneumonia Model. Infect. Immun. 71: 2956-2959 [Abstract] [Full Text]