At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 91 enrolled
Drug / intervention
Fluzone +1 morebiological
Likely dose
Fluzone and FluMist administered per standard immunization protocols (specific dosing not detailed in protocol)AI-extracted
Key inclusion· 3
- ✓Healthy, ambulatory 8-17 year old identical twins, 8-30 year old non-twins, or 70-100 year old elderly non-twin adults.
- ✓Willing and able to complete informed consent and follow-up for at least 28 days after immunization.
- ✓Acceptable medical history and vital signs.
Key exclusion· 23
- ✕Prior vaccination with seasonal TIV, LAIV, or H1N1.
- ✕Allergy to egg or egg products, or vaccine components.
- ✕Life-threatening reactions to previous influenza vaccinations.
- ✕Asthma or history of wheezing.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Protective Mechanisms Against a Pandemic Respiratory Virus. Project 1: B-cell Immunity to Influenza. Technical Development Project 1: Measuring the Immunome: Genomic Approaches to B-cell Repertoire - Years 2 (2010) & 3 (2011)
In Brief
A Phase 4 clinical trial evaluating Fluzone and FluMist for Influenza. Completed, enrolled 91 participants.
Detailed Summary
In this exploratory study, investigators will be looking at immune response differences between age groups and between the two different influenza vaccines given to identical twins, vaccine-naive young adults and elderly participants.
Study Details
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2010
Primary CompletionDec 2011
First PostedJan 2017
TodayJul 2026
First PostedJan 13, 2017
Enrollment StartSep 1, 2010
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.5 years ago
Interventions
Fluzonebiological
Influenza Virus Vaccine Suspension for Intramuscular Injection
FluMistbiological
Influenza Virus Vaccine Live, Intranasal Intranasal Spray