Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live, Cold-Adapted (CAIV-T) in Healthy Children
Study Details
Study Description
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-confirmed influenza illness. In addition, the trial provides the opportunity to investigate the efficacy of CAIV-T over multiple influenza seasons, and to investigate the effect of CAIV-T on acute otitis media.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Outcome Measures
Primary Outcome Measures
- The primary endpoint for efficacy is the first episode during the first year in a study child of a culture-confirmed influenza-illness, caused by community-acquired subtypes. []
Secondary Outcome Measures
- The secondary endpoint for efficacy is the first episode during the second year in a study child of a culture-confirmed influenza-illness. []
Eligibility Criteria
Criteria
Inclusion Criteria:
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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;
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whose parent or legal guardian has provided written informed consent after the nature of the study has been explained;
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who, along with their parent or legal guardian, will be available for the duration of the study (24 months);
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whose parent/legal guardian can be reached by study staff for the post-immunization contacts [via telephone, clinic or home visits].
Exclusion Criteria:
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whose parents or caregiver are perceived to be unreliable or difficult to contact for evaluation or study visits during the study period;
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with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;
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with Down's syndrome or other known cytogenetic disorders;
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with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids;
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who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study;
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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;
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with an immunosuppressed or compromised individual living in the same household;
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who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational);
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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;
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with a documented history of hypersensitivity to egg or egg protein, or any other component of the study vaccines or placebo;
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with a respiratory illness with wheezing within two weeks prior to enrollment;
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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;
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Prince of Wales Hospital | Hong Kong | China |
Sponsors and Collaborators
- MedImmune LLC
- Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
- Study Director: Robert Walker, MD, MedImmune LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D153-P501