At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 200 enrolled
Drug / intervention
Trivalent influenza virus vaccine live, intranasalbiological
Likely dose
Trivalent influenza virus vaccine live, intranasal 0.2 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Open-Label, Single Arm Trial to Evaluate the Shedding and Safety of CAIV-T Administered to Children 6 to Less Than 60 Months of Age
In Brief
A Phase 2 clinical trial evaluating Trivalent influenza virus vaccine live, intranasal for Healthy. Completed, enrolled 200 participants across 16 sites.
Detailed Summary
Open label, single arm, multicenter study of the shedding and safety of a single dose of trivalent, influenza virus vaccine live, intranasal in children 6 to \< 60 months of age, with 28-day shedding follow-up and 180-day safety follow-up.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2006
First PostedJun 2006
Primary CompletionJul 2006
Study CompletionDec 2006
TodayJul 2026
First PostedJun 26, 2006
Enrollment StartMay 1, 2006
Primary CompletionJul 1, 2006
Study CompletionDec 1, 2006
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 20.0 years ago
Interventions
Trivalent influenza virus vaccine live, intranasalbiological
A single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains.