Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00192166
Status:
COMPLETED
Last Update Posted:
2008-12-08
First Post:
2005-09-12
Brief Title:
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
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
- The primary objective of the study was to determine if intranasally administered influenza virus vaccine CAIV-T when administered concomitantly with a subcutaneously administered combination live attenuated mumps measles and rubella MMR virus vaccine to children interferes with the immune responses
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None