N/A
N=105
Cell Mediated Immunity in Older Adults
Immunity to Influenza Vaccine
Bottom Line
View on ClinicalTrials.gov: NCT01189123 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Cellular Immune Response — 0.239; 0.137; 0.243; 0.160 percentage of Stimulated cells
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High dose influenza vaccine Sanofi-Pasteur (Biological); fluzone by sanofi pasteur (Biological)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cellular Immune Response |
0.239; 0.137; 0.243; 0.160; 0.174; 0.147 | — |
| SECONDARY Antibody Responses |
40; 80; 20; 80; 40; 40 | — |
Summary
This study is to study the immune response to the flu vaccine in people 65 years old and older. Only adults 65 years old and older and who are getting their flu vaccine are being asked to join in this study. The investigators plan to enroll approximately 100 people in this study in the 2010-2011 flu season. Vanderbilt is working with the Centers for Disease Control and Prevention on this study.
There will be 5 study visits. Up to 4 tablespoons of blood from a vein will be obtained prior to the flu shot. Return visits will be 1, 2, and 4 weeks later,with up to 4 tablespoons of blood drawn again. Patients will be randomized to receive either the standard dose or the high dose flu vaccine. Both flu vaccines are FDA-approved.
Eligibility Criteria
Inclusion Criteria
- healthy
- aged 65+ years
Exclusion Criteria
- <65 years
- influenza vaccine allergy
- Guillain-Barre
- weight <110 pounds
Data sourced from ClinicalTrials.gov (NCT01189123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.