Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of Influenza Virus Vaccine, (CAIV-T) in Healthy Children
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|ClinicalTrials.gov Identifier: NCT00192374|
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 :||1920 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase III, Multicenter Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B,Live, Cold-Adapted (CAIV-T) in Healthy Children|
|Study Start Date :||February 2002|
|Estimated Study Completion Date :||November 2002|
- The primary efficacy endpoint was the first episode in a study child of a culture-confirmed influenza illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine.
- A secondary efficacy endpoint was the first episode of culture-confirmed influenza illness caused by any community-acquired antigenic subtype.
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): NCT00192374
|Department of Microbiology, Research Institute for Tropical Medicine|
|Muntinlupa City, Philippines|
|Queen Sirikit National Institute of Child Health (Children's Hospital)|
|Bangkok, Thailand, 10400|
|Principal Investigator:||Tawee Chotpitayasunondh, Dr.||Queen Sirikit National Institute of Child Health (Children's Hospital)|
|Principal Investigator:||Rosario Z. Capeding, Dr.||Department of Microbiology, Research Institute for Tropical Medicine|