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

MedImmune

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Biological: CAIV-T and TIV

Study type

Interventional

Funder types

Industry

Identifiers

NCT00192257

D153-P515

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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.