Abstract
influenza infection can cause sever prespiratory disease in high-risk person such as those with asthma, but immuization rates for high risk group remain subotimal. An inavestigational influezna virus vaccing, trivalenty, type A and Type B, live cold adapted (CAIV-T) administered by in-transal spray was shown previously to be diffective in healthy adults and children.
Aim of the study: This study was carried out to assess the safety and tolerability of (CAIV-T) in subject 9years of age and older in school age children with moderate to sever asthma.
Methods: Sample was double blinded placebo controlled study, we did spirometry twice befoe vaccination to establish base line forced expiratory volume (FEVI) and two (2) to five (5) days thereafer.
The primary outcome index was the percent change in perecent predict ed FEVI befor and after vaccination, Peak flows, clinical Asthma Symptoms scores and hight time awakening scores wee measured daily from 7days previous to 28days post vaccination. Secondary out come index was including number of subjects with a decrease FEVI>15% from baseline, reduction in peack flows>15% below baseline, asthma exacerbation and clinical Asthma symptoms score before and after vaccination.
Results
The primary out come index (percent chang in percent predicted FEVI) was not different:
Between the two group (Vaccinated and placebo groups)P=0.78. secondary outcomes did not differ between the two groups (number of subject with decrease FEVI>15% from base line, reduction of PERF>15% below base line, Clinical Asthma Symptoms scores before and after vaccination. No serious adverse event occurred.
conclusion: CAIV-T was generally safe and well tolerated in children and adolescents with moderate to severe Asthma.