PEDIATRICS Vol. 112 No. 2 August 2003, pp. 493
SAFETY OF THE TRIVALENT, COLD-ADAPTED INFLUENZA VACCINE IN PRESCHOOL-AGED CHILDREN
Mark H. Moss, MD
Madison, WI
Piedra PA, Yan L, Kotloff K, et al. Pediatrics. 2002;110:662–672
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Purpose of the Study.
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Influenza is a major cause of morbidity in all age groups. The
study objective was to provide safety data for the intranasally
administered, trivalent, cold-adapted influenza vaccine (CAIV-T)
in young children using a multicenter, prospective, randomized,
double-blind, placebo-controlled study.
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Study Population.
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Healthy children 15 to 71 months old were enrolled. Exclusion
criteria included history of significant hypersensitivity to
eggs or a chronic illness for which trivalent inactivated influenza
virus (IIV-T) would be recommended. Inclusion in years 2 to
4 of the study required inclusion in all of the previous consecutive
years beginning in 1996.
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Methods.
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Each year CAIV-T provided by Aviron (Mountain View, CA) contained
vaccine strains that matched antigens consistent with the licensed
US Food and Drug Administration IIV-T product. In year 1, 1314
children were enrolled in the 2-dose cohort (either active CAIV-T
or placebo) and 288 were enrolled in the 1-dose cohort. In year
2, 1358 original participants received 1 dose of CAIV-T or placebo
to match their original treatment. In years 3 and 4, 642 and
549 children, respectively, received their third and fourth
doses of CAIV-T in an open-label extension. Safety was evaluated
by measuring the occurrence of specific or unexpected symptoms
within 10 days of vaccination, incidence of an acute illness
and use of medication within 11 to 42 days of vaccination, and
occurrence of a serious adverse event within 42 days of vaccination.
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Results.
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In the first year, runny nose or nasal congestion, vomiting,
muscle aches, and fever were significantly associated with the
first dose of CAIV-T. Runny nose was the only symptom associated
with CAIV-T after the second dose. In years 2 to 4 specific
symptoms were not associated with CAIV-T. The symptoms associated
with CAIV-T were most likely to occur on day 2, after the first
dose of vaccine. Vomiting, abdominal pain, and muscle aches
were associated with the first dose of vaccine. Unexpected symptoms
most commonly involved the gastrointestinal system. A significant
increase in the use of analgesics/antipyretics was observed
with the first dose of CAIV-T compared with placebo (23.5% vs
16.6%). CAIV-T was not associated with illness or medication
use on days 11 to 42 or serious adverse events.
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Conclusions.
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CAIV-T was deemed safe in preschool-aged children. Mild respiratory,
gastrointestinal, and systemic symptoms were observed primarily
with the first dose of vaccine and occurred in a minority of
children. Subsequent consecutive annual doses of CAIV-T were
tolerated without significant effects.
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Reviewer’s Comments.
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Influenza remains a significant cause of morbidity in children.
The American Academy of Pediatrics (AAP) has recommended vaccinating
all children between 6 and 23 months of age using the IIV-T
product, especially those at high-risk of hospitalization. Nonetheless,
most children are still not immunized, perhaps because of a
lack of desire to use the injectable product. This study demonstrates
that the CAIV-T is safe with minimal side effects in healthy
children. Hopefully, we will see this vaccine come to market
in the near future.
PEDIATRICS (ISSN 1098-4275). ©2003 by the American Academy of Pediatrics
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Purpose of the Study.
Study Population.
