Trial Outcomes & Findings for Cell Mediated Immunity in Older Adults (NCT NCT01189123)
NCT ID: NCT01189123
Last Updated: 2014-04-24
Results Overview
comparison of CMI in high vs standard dose
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
105 participants
Primary outcome timeframe
3 years
Results posted on
2014-04-24
Participant Flow
Participant milestones
| Measure |
Standard Dose Influenza Vaccine
Fluzone (Sanofi Pasteur)
fluzone by sanofi pasteur: standard dose fluzone
1 dose of vaccine was given IM
|
High Dose Vaccine
High Dose Fluzone by sanofi pasteur
High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
53
|
|
Overall Study
COMPLETED
|
50
|
47
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cell Mediated Immunity in Older Adults
Baseline characteristics by cohort
| Measure |
Standard Dose Influenza Vaccine
n=52 Participants
Fluzone (Sanofi Pasteur)
fluzone by sanofi pasteur: standard dose fluzone
|
High Dose Vaccine
n=53 Participants
High Dose Fluzone by sanofi pasteur
High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74 years
n=5 Participants
|
72 years
n=7 Participants
|
73 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
52 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
53 participants
n=7 Participants
|
105 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: A subset of samples were chosen for testing since not enough money was available to test samples from all subjects. The samples were divided by randomization group (blinded to study staff -- they were called group A or group B). From each group, samples were randomly pulled.
comparison of CMI in high vs standard dose
Outcome measures
| Measure |
Standard Dose Influenza Vaccine
n=22 Participants
Fluzone (Sanofi Pasteur)
fluzone by sanofi pasteur: standard dose fluzone
|
High Dose Vaccine
n=26 Participants
High Dose Fluzone by sanofi pasteur
High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)
|
|---|---|---|
|
Cellular Immune Response
CD8+ TNF alpha Visit 4
|
0.344 percentage of Stimulated cells
Interval 0.163 to 0.472
|
0.277 percentage of Stimulated cells
Interval 0.126 to 0.485
|
|
Cellular Immune Response
CD4+ IFNgamma at Visit 4
|
0.239 percentage of Stimulated cells
Interval 0.124 to 0.396
|
0.137 percentage of Stimulated cells
Interval 0.098 to 0.2
|
|
Cellular Immune Response
CD4+ TNF alpha Visit 4
|
0.243 percentage of Stimulated cells
Interval 0.138 to 0.413
|
0.160 percentage of Stimulated cells
Interval 0.107 to 0.221
|
|
Cellular Immune Response
CD4+ IL2 Visit 4
|
0.174 percentage of Stimulated cells
Interval 0.107 to 0.26
|
0.147 percentage of Stimulated cells
Interval 0.124 to 0.192
|
|
Cellular Immune Response
CD8+ IFNgamma at Visit 4
|
0.162 percentage of Stimulated cells
Interval 0.101 to 0.311
|
0.191 percentage of Stimulated cells
Interval 0.13 to 0.324
|
|
Cellular Immune Response
CD8+ IL2 Visit 4
|
0.200 percentage of Stimulated cells
Interval 0.107 to 0.276
|
0.167 percentage of Stimulated cells
Interval 0.108 to 0.289
|
SECONDARY outcome
Timeframe: 2 yearsHemagglutination inhibition antibody titers measured for standard vs high dose
Outcome measures
| Measure |
Standard Dose Influenza Vaccine
n=50 Participants
Fluzone (Sanofi Pasteur)
fluzone by sanofi pasteur: standard dose fluzone
|
High Dose Vaccine
n=47 Participants
High Dose Fluzone by sanofi pasteur
High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)
|
|---|---|---|
|
Antibody Responses
H1N1
|
40 GMT
Interval 10.0 to 80.0
|
80 GMT
Interval 40.0 to 160.0
|
|
Antibody Responses
H3N2
|
20 GMT
Interval 20.0 to 40.0
|
80 GMT
Interval 40.0 to 160.0
|
|
Antibody Responses
B
|
40 GMT
Interval 20.0 to 80.0
|
40 GMT
Interval 40.0 to 80.0
|
Adverse Events
Standard Dose Influenza Vaccine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Dose Vaccine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place