NCT00192491

Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (FluMist) and Measles, Mumps, Rubella, and Varicella Vaccines Administered Concurrently to Healthy Children

A Randomized, Placebo-Controlled, Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (FluMist) and Measles, Mumps, Rubella, (MMRIIÒ) and Varicella (VARIVAXÒ) Vaccines Administered Concurrently to Healthy Children (AV018)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 12 Months – 15 Months
• Healthy volunteers: Accepted

Summary

* To compare immune responses to measles, mumps, rubella, and varicella antigens following vaccination in children who receive FluMist concurrently with MMRIIÒ and VARIVAXÒ and in children who receive an intranasal placebo mist concurrently with MMRIIÒ and VARIVAXÒ (Group 2 vs. Group 1). * To compare immune responses to the three strains of influenza (H1N1, H3N2, and B) following a two dose regimen of FluMist in children who receive the initial FluMist dose concurrently with MMRIIÒ and VARIVAXÒ and in children who receive two doses of FluMist alone (Group 2 vs. Group 3).Secondary: * To assess the safety and tolerability of concurrent administration of FluMist with MMRIIÒ and VARIVAXÒ.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	FluMist	Nasal Sprayer of one dosage of FluMist and other experimental
BIOLOGICAL	FluMist	Nasal sprayer of FluMist
OTHER	Placebo	Nasal Sprayer of Placebo

Timeline

• Start date: 2000-12-01
• Primary completion: 2003-09-01
• Completion: 2003-12-01
• First posted: 2005-09-19
• Last updated: 2008-02-08