Status:
COMPLETED
Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A and B, Live Cold-adapted (CAIV-T) in Healthy Children
Lead Sponsor:
MedImmune LLC
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Healthy
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
Brief Summary
The study was designed to determine the number of doses of CAIV-T required to effectively immunize children and adolescents in the 6 to 17 year age group.
Detailed Description
This was a phase II, prospective, open-label, multicenter, outpatient study designed to evaluate the safety, tolerability, and immunogenicity of one or two doses of CAIV-T in children and adolescents ...
Eligibility Criteria
Inclusion
- who are at least 6 years and not more than 17 years of age at the time of enrollment;
- who, if female and is post-menarche, has provided a negative pregnancy test; · who are in good health as determined by medical history, physical examination and clinical judgement;
- who have provided written informed consent (as appropriate and according to national guidelines) and whose parent(s) or legal guardian(s) have provided written informed consent after the nature of the study has been explained; 13 who, along with their parent(s) or legal guardian(s), will be available for duration of the study (approximately three months);
- who, together with their parent(s) or legal guardian(s), can be reached by study staff for the post-vaccination contacts \[telephone, clinic visit or home visit\].
Exclusion
- who are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period and whose parent(s) or legal guardian(s) are perceived to be unreliable 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;
- 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;
- have an immunosuppressed or immuno-compromised individual living in the same household;
- who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational)
- who, in the two weeks prior to entry into this study, received a dose of any influenza treatment (commercial or investigational)
- with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine;
- with a clinically confirmed respiratory illness with wheezing within two weeks prior to enrollment;
- 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;
- who were administered any live virus vaccine within one month prior to enrollment or expect receipt of another live virus vaccine within one month of vaccination in this study;
- with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results; If any of these criteria are met following enrolment, the subject will be excluded from subsequent vaccine dosing.
- Note: A pregnant household member is not considered a contraindication to enrollment.
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2001
Estimated Enrollment :
498 Patients enrolled
Trial Details
Trial ID
NCT00192270
Start Date
October 1 2000
End Date
January 1 2001
Last Update
March 6 2012
Active Locations (3)
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1
University of Antwerp
Antwerp, Belgium, 2610
2
Dienst Jeugdgezondheidszorg
Leuven, Belgium, 3000
3
Oulu University Hospital
Oulu, Finland, 90220