Trial to Compare the Safety, Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus in Children With Asthma
NCT00192257
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- 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].
- 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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Descriptive Information | ||||
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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 | 2229 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | May 2003 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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 |
| |||
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 |
| |||
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 |