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Sponsors and Collaborators: |
MedImmune LLC Wyeth |
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Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00192283 |
The purpose of this study is to determine the efficacy of the liquid formulation of CAIVT against culture confirmed influenza illness in healthy children aged at least 6 months and less than 36 months, attending day care centers in Europe. In addition, the trial provides the opportunity to investigate the effect of CAIV-T on acute otitis media, on healthcare resource utilization and economic resources.
Condition | Intervention | Phase |
---|---|---|
Influenza |
Biological: CAIV-T |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment |
Official Title: | A Prospective, Randomized, Double-Blind, Placebo-Controlled, Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) in Healthy Children Attending Day Care Centers |
Estimated Enrollment: | 1500 |
Study Start Date: | September 2000 |
Ages Eligible for Study: | 6 Months to 36 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Note: A pregnant household member is not considered a contraindication to enrollment.
Study ID Numbers: | D153 P502 |
Study First Received: | September 12, 2005 |
Last Updated: | October 23, 2006 |
ClinicalTrials.gov Identifier: | NCT00192283 |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Influenza, Human Healthy Orthomyxoviridae Infections |
RNA Virus Infections |