At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 101 enrolled
Drug / intervention
TIV, Trivalent Inactivated Influenza Virus Vaccine +1 morebiological
Likely dose
TIV, Trivalent Inactivated Influenza Virus Vaccine 0.25 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, Prospective, Randomized, Open-Label Study to Evaluate the Immune Responses of FluMist® Compared With Trivalent Inactivated Vaccine (TIV) in Children 12 to <36 Months of Age
In Brief
A Phase 2 clinical trial evaluating TIV, Trivalent Inactivated Influenza Virus Vaccine and FluMist, Influenza Virus Vaccine Live for Influenza Vaccine. Completed, enrolled 101 participants across 19 sites.
Detailed Summary
The primary objective of this study is to describe the level of serum antibody and cellular immune responses conferred by FluMist and TIV against influenza virus strains.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza Vaccine
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2007
Enrollment StartMay 2007
Primary CompletionDec 2007
Study CompletionFeb 2008
TodayJul 2026
First PostedApr 18, 2007
Enrollment StartMay 1, 2007
Primary CompletionDec 1, 2007
Study CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 19.2 years ago
Interventions
TIV, Trivalent Inactivated Influenza Virus Vaccinebiological
0.25 mL will be administered intramuscularly for each of two doses
FluMist, Influenza Virus Vaccine Livebiological
0.5 mL will be administered intranasally (approximately 0.25 mL into each nostril) for each of two doses