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

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00192257
First received: September 12, 2005
Last updated: October 2, 2006
Last verified: October 2006
  Purpose

- 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.


Condition Intervention Phase
Asthma
Biological: CAIV-T and TIV
Phase 3

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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 2229
Study Start Date: October 2002
Estimated Study Completion Date: May 2003
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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192257

Locations
Belgium
Berchem, Belgium
Brussels, Belgium
Sponsors and Collaborators
MedImmune LLC
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Robert Walker, M.D. MedImmune LLC
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00192257     History of Changes
Other Study ID Numbers: D153-P515
Study First Received: September 12, 2005
Last Updated: October 2, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Influenza, Human
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 20, 2014