Trial to Compare the Safety, Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus in Children With Asthma

Study Overview
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Brief Summary
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- 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
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- 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.

Official Title
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A Prospective, Randomized, Open-Label, Controlled Trial to Compare the Safety, Tolerability and Efficacy of Influenza Virus Vaccine, Trivalent, Type A&B, Live, Cold-Adapted (CAIV-T) With Influenza Virus Vaccine, Trivalent, Inactivated (TIV) in Children With Asthma Aged 6 Years to 17 Years

Conditions
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Asthma

Intervention / Treatment
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* Biological: CAIV-T and TIV


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: CAIV-T and TIV|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  |