Status:
COMPLETED
Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & 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
6-35 years
Phase:
PHASE3
Brief Summary
\- The purpose of this study is to determine the efficacy of CAIV-T in a diverse Asian population aged from 6 months to less than 36 months, in tropical and temperate climates, against culture-confirm...
Eligibility Criteria
Inclusion
- who are greater than or equal to 6 months and less than 36 months of age at the time of enrollment, and in good health as determined by medical history, physical examination, and clinical judgment;
- whose parent or legal guardian has provided written informed consent after the nature of the study has been explained;
- who, along with their parent or legal guardian, will be available for the duration of the study (24 months);
- whose parent/legal guardian can be reached by study staff for the post-immunization contacts \[via telephone, clinic or home visits\].
Exclusion
- whose parents or caregiver 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;
- with an immunosuppressed or 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 were administered any live virus vaccine within one month prior to study vaccination or expected receipt of another live virus within one month of vaccination in this study;
- with a documented history of hypersensitivity to egg or egg protein, or any other component of the study vaccines or placebo;
- with a 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;
- with any medical conditions that in the opinion of the Investigator might interfere with interpretation of the study results; Note: A pregnant household member or day care provider is not considered a contraindication to enrollment.
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
End Date :
October 1 2002
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT00192244
Start Date
September 1 2000
End Date
October 1 2002
Last Update
October 3 2006
Active Locations (1)
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1
The Prince of Wales Hospital
Hong Kong, China