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Day care children saw reduction in RTIs after nine-valent pneumococcal vaccine

A nine-valent pneumococcal vaccine affected morbidity and antibiotic use in the day care setting.

[Reduction in infection]

[Your turn]

June 2000

BOSTON - The nine-valent pneumococcal CRM₁₉₇ vaccine (PncCRM9, Wyeth Lederle) had a major impact on morbidity and antibiotic use in the day care setting, according to a study of 264 healthy Israeli children ages 12 to 35 months. The vaccine was similar to the U.S.-licensed pneumococcal conjugate vaccine (Prevnar, Wyeth Lederle Vaccines), but included two additional strains prevalent outside of the United States.

Study Conclusions

The 9-valent Pnc-CRM 197 vaccine has a major impact on morbidity and antibiotic use in day care center attendees. The type and incidence of disease and antibiotic use patterns in day care centers in the present study seem similar to those in the United States. Children <5 years old attending day care centers may benefit from the new conjugate Pnc vaccines. Source: Ron Dagan, MD

"It was demonstrated for the first time that vaccinating children in day care against pneumococcal disease can reduce bouts of illness and reliance on the antibiotics that treat those illnesses," said Ron Dagan, MD, professor of pediatrics and infectious diseases, Ben-Gurion University and director, pediatric infectious disease unit, Soroka University Medical Center in Beer-Sheva, Israel. "We're losing our weapons against pneumococcal disease. If we can prevent disease, we can limit use of antibiotics and stave off resistance."

Study participants from eight day care centers in Israel were randomized to receive either the PncCRM9 (132 patients) or the control vaccine, meningococcus-C-CRM conjugate (136 patients). Children ages 12 to 17 months received two doses and children ages 18 to 35 months received one dose. Most study participants received just one dose of vaccine.

According to the double-blinded study, presented at the Pediatric Academic Societies and American Academy of Pediatrics joint meeting held here, participants were followed for 5,556 months, with an average follow-up time of 21.3 months per child.

Follow-up visits were planned every month during the first year of the two-year study, and every two to three months during the second year. Only episodes starting more than one month after complete immunization were recorded.

"With each follow-up visit, [parents filled out] a questionnaire about disease and antibiotic use since the last visit," said Dagan, who is also a member of Infectious Diseases in Children editorial board.

Morbidity was defined as, but not limited to, upper respiratory infection (URI); lower respiratory infections (LRI), including bronchitis, bronchiolitis, asthma and clinical pneumonia; and acute otitis media (AOM).

Reduction in infection

Study data showed that in the PncCRM9 group, there was a 15% reduction in all respiratory tract infections from any cause; a 16% reduction in LRI from any cause (2%-28%); a 17% reduction in AOM (2%-33%); a 15% reduction in URI and fever from any cause (4%-24%); a 53% reduction in antibiotic use for LRI; and a 20% reduction in antibiotic use for AOM.

At least one episode of morbidity was reported in 43.9% of those vaccinated in the PncCRM9 group, and 46.8% of those vaccinated in the control group. The relative risk was 0.94 (P=.033).

The percentage of positive child months in the control patients for LRI, AOM and URI was 11.7, 6.5 and 17.6, respectively. Respective relative risks among those vaccinated were 0.82, 0.82 and 0.85. No difference was found for diarrhea or varicella.

Data showed study participants received antibiotics for a total of 7,261 antibiotic days, with a relative risk of 0.84 for those vaccinated. Relative risks for antibiotic days for LRI were 0.53; 0.80 for AOM; and 0.84 for URI.

According to the study, frequency of episodes and antibiotic days were significantly higher for children younger than 36 months old, but had a lower relative risk compared with those who were 36 months.

The study findings are especially significant because figures from the National Center for Education Statistics indicate approximately 60% of U.S. children younger than 6 years attend some type of day care.

For more information:

• Dagan R, Sikuler-Cohen M, Givon-Lavi N et al. A 9-valent pneumococcal CRM₁₉₇ vaccine (PncCRM9) has a major impact on morbidity and antibiotic (AB) use in day care centers (DCCs). Abstract 1530. Presented at the Pediatric Academic Societies and American Academy of Pediatrics joint meeting. May 12-16, 2000. Boston.

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Copyright 2000, SLACK Incorporated. Revised 15 September 2000.