Trivalent, cold-adapted flu vaccine well-tolerated by preschool-aged children.

2002 DEC 11 - (NewsRx.com & NewsRx.net) -- The trivalent, cold-adapted influenza vaccine (CAIV-T) appears safe in children under age 6, according to a recent study.

Baylor College of Medicine researcher P.A. Piedra and colleagues conducted a multicenter, prospective, randomized, double-blind, placebo-controlled trial in which children between the ages of 15 months and 71 months received either CAIV-T or placebo.

"In year 1 (1996-1997)," the researchers said, 1314 [children] were enrolled in the two-dose cohort and 288 were enrolled in the one-dose cohort. In year 2 (1997-1998), 1358 of the original participants received one dose of vaccine or placebo according to their original treatment group assignment. In year 3 (1998-1999) and year 4, the trial continued as an open-label safety trial of CAIV-T. A total of 642 and 549 children enrolled in years 3 and 4, respectively, received their third and fourth sequential annual doses of CAIV-T."

Piedra and team collected data on:

* "the occurrence of specific respiratory, gastrointestinal and systemic symptoms, unexpected symptoms (not specified in the diary card), and use of medications within the first 10 days after vaccination;

* the occurrence of an acute illness and use of medication within 11 to 42 days after vaccination; and

* the occurrence of serious adverse events within 42 days after vaccination."