trial to compare the safety, tolerability and efficacy of influenza virus vaccine, (caiv-t) with influenza virus in children with asthma

Conditions: Asthma

Summary: - trial to assess asthma exacerbation through to the end of the study; and to demonstrate that the efficacy over one season against culture-confirmed influenza-illness; and finally to assess the safety and tolerability of caiv-t in children with asthma.

- to assess asthma exacerbation, being defined as acute wheezing illness associated with hospitalization, unscheduled clinic visits, or new prescriptions from study vaccination through to the end of the study.

Eligibility criteria:
inclusion criteria: * who are aged at least 6 years to 17 years of age at the time of enrollment; * with a clinical diagnosis of asthma by one of the following criteria: * an international classification of diseases, ninth revision (icd-9) code 493 and ≥one prescription for asthma medication; * or ≥one prescription for an inhaled beta-agonist and ≥one prescription for cromolyn; * or ≥five prescriptions for any asthma medication (adapted from kramarz et al,2000 and osborne et al., 1995)1,2; * asthma medication\* is being defined as: * inhaled and oral β -agonists * theophyllin * inhaled, oral and injected steroids * other unclassified asthma medication * antibiotics used for treatment of respiratory illness associated with a wheezing episode; * at least one asthma medication should have been administered in the last 12 months * who, if female and is post-menarche, has provided a negative pregnancy test prior to the study vaccination; * who have provided written informed consent (as appropriate and according to national guidelines) and whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained; * who, along with their parent(s)/legal guardian(s), will be available for duration of the trial; * who/whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts \[telephone, clinic or home visit\]. exclusion criteria: * who/whose parent(s)/legal guardian(s) are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period; * with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease; * with down's syndrome or other known cytogenetic disorders; * with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids of a dose equivalent to a total of 20 mg/day or greater of prednisolone or equivalent, for more than 14 days duration until 2 weeks after corticosteroids have been discontinued 25; * who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study; * for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study; * who have an immunosuppressed or an immunocompromised individual living in the same household; * who received any influenza vaccine in the 6 months prior to enrollment, or are anticipated to receive a non-study influenza vaccine after enrollment; * with a documented history of hypersensitivity to egg or egg protein or any other component of the caiv-t or tiv; * who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrollment or for which use is anticipated during the study; * with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results; note: pregnancy in any person who has regular contact with the subject is not a contraindication to the enrollment or ongoing participation of the subject in the study.