Asthma
Conditions
Brief 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.
Detailed description
\- 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.
Interventions
BIOLOGICALCAIV-T and TIV
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demostrate that the efficacy over one influenza season against culture-confirmed influenza illness caused by community-acquired subtypes antifenically similar to those contained in the vaccine | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate that the efficacy over one season of a single dose of CAIV-T was not inferior to that of one dose of TIV against culture-confirmed influenza-illness of any subtype | — |
| To compare the efficacy over a defined surveillance period against asthma exacerbations, asthma medication, clinical visits, hospitalizations, days off school (pharma-ecomonic measures) associated with influenza-like illness | — |
Countries
Belgium
Outcome results
None listed