Trial Outcomes & Findings for Impact of Metabolic Syndrome on Flu Vaccine Efficacy (NCT NCT02653495)
NCT ID: NCT02653495
Last Updated: 2017-09-28
Results Overview
Measured by hemagglutination inhibition assay
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
28 days after vaccination compare to baseline (screening visit 1) pre-vaccination
Results posted on
2017-09-28
Participant Flow
Advertising and Research Volunteer Repository Database
Pre-screening took place along with a two-step screening visit for eligibility criteria. Those not meeting eligibility would screen out: 86 prescreened, 28 initial contact for screening.
Participant milestones
| Measure |
Influenza Vaccine in Metabolic Syndrome
Influenza vaccine
Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3
|
Influenza Vaccine in Healthy Controls
Influenza vaccine
Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
12
|
0
|
Reasons for withdrawal
| Measure |
Influenza Vaccine in Metabolic Syndrome
Influenza vaccine
Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3
|
Influenza Vaccine in Healthy Controls
Influenza vaccine
Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Screening Failure
|
10
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Influenza Vaccine in Metabolic Syndrome
n=3 Participants
Influenza vaccine
Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3
|
Influenza Vaccine in Healthy Controls
n=2 Participants
Influenza vaccine
Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=3 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=3 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=5 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
2 participants
n=2 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days after vaccination compare to baseline (screening visit 1) pre-vaccinationPopulation: Data were not collected
Measured by hemagglutination inhibition assay
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 day post-vaccination compare to baseline (gene expression screening visit #1 and study visit #1 D0 of vaccination)Population: Data were not collected.
Analyze by RNA-seq
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 days post-vaccination compare to baseline (gene expression screening visit #1 and study visit #1 D0 of vaccination)Population: Data were not collected.
Analyze by RNA-seq
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 days post-vaccination compare to baseline (gene expression screening visit #1 and study visit #1 D0 of vaccination)Population: Data were not collected.
Analyze by RNA-seq
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 days after vaccination compare to day 28Population: Data were not collected.
Measured by hemagglutination inhibition assay
Outcome measures
Outcome data not reported
Adverse Events
Influenza Vaccine in Metabolic Syndrome
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Influenza Vaccine in Healthy Controls
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Influenza Vaccine in Metabolic Syndrome
n=3 participants at risk
Influenza vaccine
Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3
|
Influenza Vaccine in Healthy Controls
n=2 participants at risk
Influenza vaccine
Influenza vaccine: Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
infections and infestations: upper respiratory infection: skin infection
|
33.3%
1/3 • Number of events 1 • Adverse event information collected from time of enrollment through completion of study visits, 3 months.
|
0.00%
0/2 • Adverse event information collected from time of enrollment through completion of study visits, 3 months.
|
|
Gastrointestinal disorders
gastrointestinal disorders: dyspepsia
|
0.00%
0/3 • Adverse event information collected from time of enrollment through completion of study visits, 3 months.
|
50.0%
1/2 • Number of events 1 • Adverse event information collected from time of enrollment through completion of study visits, 3 months.
|
|
Gastrointestinal disorders
gastrointestinal disorders: diarrhea
|
33.3%
1/3 • Number of events 1 • Adverse event information collected from time of enrollment through completion of study visits, 3 months.
|
0.00%
0/2 • Adverse event information collected from time of enrollment through completion of study visits, 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory
|
33.3%
1/3 • Number of events 1 • Adverse event information collected from time of enrollment through completion of study visits, 3 months.
|
0.00%
0/2 • Adverse event information collected from time of enrollment through completion of study visits, 3 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place