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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00192257
• Other study ID #: D153-P515
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: October 2, 2006
• Start date: October 2002
• Est. completion date: May 2003

Study information

• Verified date: October 2006
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2229
• Est. completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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 ß -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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• CAIV-T and TIV

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
MedImmune LLC	Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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