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

MedImmune LLC0 sites2,229 target enrollmentOctober 2002

ConditionsAsthma

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Asthma
Sponsor: MedImmune LLC
Enrollment: 2229
Primary Endpoint: 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
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2002

End Date

May 2003

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

MedImmune LLC

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

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;

Outcomes

Primary Outcomes

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 Outcomes

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