Influenza Clinical Trial
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
- 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.
- 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.
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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