Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live, Cold-Adapted (CAIV-T) in Healthy Children
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|ClinicalTrials.gov Identifier: NCT00192244|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : October 3, 2006
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Biological: CAIV-T, Liquid||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3000 participants|
|Intervention Model:||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|
|Study Start Date :||September 2000|
|Estimated Study Completion Date :||October 2002|
- 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.
- The secondary endpoint for efficacy is the first episode during the second year in a study child of a culture-confirmed influenza-illness.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00192244
|The Prince of Wales Hospital|
|Hong Kong, China|
|Study Director:||Robert Walker, MD||MedImmune LLC|