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

NCT00192257

Last updated date
Study Location
Berchem, , , Belgium
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Asthma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-17 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Trial to Compare the Safety, Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus in Children With Asthma
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE Biological: CAIV-T and TIV
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 12, 2005)
2229
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE May 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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 ? -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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00192257
Other Study ID Numbers  ICMJE D153-P515
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE MedImmune LLC
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Director:Robert Walker, M.D.MedImmune LLC
PRS Account MedImmune LLC
Verification Date October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP