PEDIATRICS Vol. 114 No. 2 August 2004, pp. 553-554
EFFECT OF CONJUGATE PNEUMOCOCCAL VACCINE FOLLOWED BY POLYSACCHARIDE PNEUMOCOCCAL VACCINE ON RECURRENT ACUTE OTITIS MEDIA: A RANDOMIZED STUDY
Ophelia M. Chen, MD and
Michael S. Kaplan, MD
Los Angeles, CA
Veenhoven R, Bogaert D, Uiterwaal C, et al. Lancet. 2003;361:2189–2195
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Purpose of the Study.
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To determine whether pneumococcal conjugate vaccine can prevent
acute otitis media (AOM) among older children who have experienced
previous episodes of AOM.
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Study Population.
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A total of 383 children (1–7 years of age) with
2 episodes
of AOM in the year before study entry were studied.
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Methods.
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Children recruited from a Netherlands general hospital and tertiary
care hospital were randomized to receive either 7-valent pneumococcal
conjugate vaccine followed by 23-valent pneumococcal polysaccharide
or hepatitis A or B vaccines, in a double-blind trial. The randomization
was stratified into 4 groups according to age (12–24 months
versus 25–84 months) and the number of prior AOM episodes
(from parental reports, with physician confirmation) (2 or 3
episodes vs
4 episodes). All children were monitored, via parental
diaries and clinical examinations, for 18 months for the recurrence
of AOM. Cultures of middle ear fluid and nasopharyngeal swabs
were performed to assess the association of pneumococcal serotypes
with AOM after vaccination.
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Results.
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Of the 383 children enrolled, 190 received pneumococcal vaccinations
and 193 received control hepatitis vaccinations. A total of
474 episodes of AOM were diagnosed during the follow-up period
after the final vaccination, with 275 recorded for 107 of the
186 children in the pneumococcal vaccine group (58%) and 200
recorded for 101 of 181 control subjects (56%). There was no
decrease in AOM in the pneumococcal vaccine group, compared
with the control group. Data from parental diaries indicated
no differences between the pneumococcal vaccine group and the
control group with respect to AOM symptom duration, symptom
frequency, or use of treatment. Serial nasopharyngeal swabs
obtained before and after vaccination in the pneumococcal vaccine
group demonstrated a decrease in the conjugated vaccine serotypes
but no overall decrease in the nasopharyngeal carriage of pneumococcus,
compared with the control group.
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Conclusions.
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There was no reduction in AOM episodes in the pneumococcal vaccine
group, compared with the control group. Overall, there was no
decrease in the carriage of pneumococcus.
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Reviewers’ Comments.
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Importantly, pneumococcal vaccination decreases the proliferation
of conjugate vaccine serotypes and thus decreases nasopharyngeal
carriage of the most frequent pneumococcal serotypes until children
are older and immunologically more mature. Furthermore, the
risk of older children developing recurrent AOM seems independent
of receiving the pneumococcal vaccination. This study supports
our current clinical practice of early childhood pneumococcal
vaccination, without catch-up immunization of older children
who might not have received the vaccine previously.
PEDIATRICS (ISSN 1098-4275). ©2004 by the American Academy of Pediatrics
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Purpose of the Study.
Study Population.
