Impact of the pneumococcal conjugate vaccine on otitis media.
BACKGROUND
The heptavalent pneumococcal conjugate vaccine (PCV) is recommended for infants to protect against invasive disease, but its impact on otitis might also have public health importance.


OBJECTIVE
To examine the impact of PCV on the incidence of otitis media, frequent otitis media and tympanostomy tube procedures and to assess whether the effectiveness of the vaccine wanes after age 24 months and varies by race, sex or season.


METHODS
From 1995 to 1998, 37 868 children at Kaiser Permanente in Northern California were randomized to receive PCV or a control vaccine in a double blind trial and were followed through April 1999.


METHODS
Children received a primary series at 2, 4 and 6 months of age and a booster at 12 to 15 months.


METHODS
Visits for otitis, frequent visits for otitis and tympanostomy tube procedures. Otitis was ascertained from diagnosis checklists routinely marked by physicians.


RESULTS
Control children averaged 1.8 otitis visits per year. Children given PCV had fewer otitis visits than control children in every age group, sex, race and season examined. Intention-to-treat analysis permitted rejection of the null hypothesis that PCV is ineffective against otitis media (P < 0.0001). In children who completed the primary series per protocol, PCV reduced otitis visits by 7.8% [95% confidence interval (CI), 5.4 to 10.2%] and antibiotic prescriptions by 5.7% (CI 4.2 to 7.2%). Frequent otitis was reduced by amounts that increased with otitis frequency, from a 10% reduction in the risk of 3 visits to a 26% reduction in the risk of 10 visits within a 6-month period. Tube placements were reduced by 24% (CI 12 to 35%).


CONCLUSIONS
In children followed up to 3.5 years, PCV provided a moderate amount of protection against ear infections while reducing frequent otitis media and tube procedures by greater amounts.
Fireman
Bruce
B
Kaiser Permanente Division of Research and the Kaiser Permanente Vaccine Studies Center, Oakland, CA 94612, USA. bruce.fireman@kp.org
Black
Steven B
SB
Shinefield
Henry R
HR
Lee
Janelle
J
Lewis
Edwin
E
Ray
Paula
P
D002675:Child, Preschool; D004306:Dose-Response Relationship, Immunologic; D004311:Double-Blind Method; D005260:Female; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D006801:Humans; D007223:Infant; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D008876:Middle Ear Ventilation / Q000009:adverse effects; D010033:Otitis Media / Q000382:microbiology / Q000517:prevention & control*; D011008:Pneumococcal Infections / Q000276:immunology / Q000517:prevention & control*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D012621:Seasons; D013296:Streptococcus pneumoniae / Q000276:immunology
D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D022401:Meningococcal Vaccines; D022242:Pneumococcal Vaccines