Trial to Assess Safety, Efficacy, Tolerability and Immunogenicity of Influenza Virus Vaccine, Liquid Formulation (CAIV-T), Administered Concomitantly With a Combination Live, Attenuated, Mumps, Measles, and Rubella Vaccine in Healthy Children Aged 11 - 24 Months
|ClinicalTrials.gov Identifier: NCT00192166|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : December 8, 2008
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: CAIV-T||Phase 2|
- The primary objective of the study was to determine if intranasally administered influenza virus vaccine, trivalent, types A and B, live, cold-adapted (CAIV-T), when administered concomitantly with a subcutaneously administered combination live, attenuated mumps, measles, and rubella (MMR) virus vaccine to children aged 11 to less than 24 months, interferes with the immune responses to the measles, mumps, and rubella components of the MMR vaccine.
- To compare the efficacy over one season against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine, in children who are aged at least 11 months and less than 24 months at enrollment, between those who receive two doses of CAIV-T and those who receive placebo, each with concomitant administration of a combination live, attenuated MMR vaccine administered prior to the anticipated commencement of the influenza season.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Trial to Assess Safety, Efficacy, Tolerability and Immunogenicity of Influenza Virus Vaccine, Administered Concomitantly With a Combination Live, Attenuated, Mumps, Measles, and Rubella Vaccine in Healthy Children Aged 11 - 24 Months|
|Study Start Date :||October 2002|
|Primary Completion Date :||March 2003|
|Study Completion Date :||May 2003|
- All episodes of AOM, occurring during the influenza season, associated with a positive culture for influenza virus antigenically similar to those contained in the vaccine.
- The first episode during the influenza season of AOM associated with a positive culture for influenza virus; all episodes during the influenza season of AOM; all during the influenza season, of AOM associated with fever.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00192166
|Respiratory Medicine Service|
|Singapore, Singapore, 229899|
|Principal Investigator:||Lucy Chai-See Lum, Prof.||University of Malaya Medical Centre|