Trials / Completed
CompletedNCT00192166
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
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1,200 (planned)
- Sponsor
- MedImmune LLC · Industry
- Sex
- All
- Age
- 11 Months – 24 Months
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CAIV-T |
Timeline
- Start date
- 2002-10-01
- Primary completion
- 2003-03-01
- Completion
- 2003-05-01
- First posted
- 2005-09-19
- Last updated
- 2008-12-08
Locations
1 site across 1 country: Singapore
Source: ClinicalTrials.gov record NCT00192166. Inclusion in this directory is not an endorsement.