Trial Outcomes & Findings for Systems Biology of Flu Vaccine in Healthy Adults With and Without the Use of Antibiotics (NCT NCT02154061)
NCT ID: NCT02154061
Last Updated: 2018-08-15
Results Overview
Number of participants with four fold rise in HAI titers or HAI 1:40 and above in each group at D30 will be recorded based on immunologic testing of blood samples
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
At day 30
Results posted on
2018-08-15
Participant Flow
Participant milestones
| Measure |
IIV Flu Vaccine With Antibiotics
This arm will receive antibiotics prior and after IIV administration.
Arm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine.
Metronidazole: This is a standard antibiotic
Neomycin: This is a standard antibiotic.
Vancomycin: This is a standard antibiotic.
|
IIV Flu Vaccine
This arm will not take antibiotics in conjunction with IIV.
Arm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
|
Overall Study
COMPLETED
|
14
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
IIV Flu Vaccine With Antibiotics
This arm will receive antibiotics prior and after IIV administration.
Arm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine.
Metronidazole: This is a standard antibiotic
Neomycin: This is a standard antibiotic.
Vancomycin: This is a standard antibiotic.
|
IIV Flu Vaccine
This arm will not take antibiotics in conjunction with IIV.
Arm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine.
|
|---|---|---|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
enrolled but not vaccinated
|
1
|
0
|
Baseline Characteristics
Systems Biology of Flu Vaccine in Healthy Adults With and Without the Use of Antibiotics
Baseline characteristics by cohort
| Measure |
IIV Flu Vaccine With Antibiotics
n=16 Participants
This arm will receive antibiotics prior and after IIV administration.
Arm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine.
Metronidazole: This is a standard antibiotic
Neomycin: This is a standard antibiotic.
Vancomycin: This is a standard antibiotic.
|
IIV Flu Vaccine
n=17 Participants
This arm will not take antibiotics in conjunction with IIV.
Arm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
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
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At day 30Population: The Overall Number of Participants analyzed for "IIV Flu Vaccine with Antibiotics" is 15, as one participant received antibiotics and did not receive vaccine. The study personnel were unable to draw blood on her at the vaccination day- therefore she was part of the safety population and not the immunogenicity population.
Number of participants with four fold rise in HAI titers or HAI 1:40 and above in each group at D30 will be recorded based on immunologic testing of blood samples
Outcome measures
| Measure |
IIV Flu Vaccine With Antibiotics
n=15 Participants
This arm will receive antibiotics prior and after IIV administration.
Arm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine.
Metronidazole: This is a standard antibiotic
Neomycin: This is a standard antibiotic.
Vancomycin: This is a standard antibiotic.
|
IIV Flu Vaccine
n=17 Participants
This arm will not take antibiotics in conjunction with IIV.
Arm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine.
|
|---|---|---|
|
Number of Participants With Four Fold Rise in HAI Titers or HAI 1:40 and Above in Each Group at D30
|
15 Participants
|
17 Participants
|
Adverse Events
IIV Flu Vaccine With Antibiotics
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
IIV Flu Vaccine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IIV Flu Vaccine With Antibiotics
n=16 participants at risk
This arm will receive antibiotics prior and after IIV administration.
Arm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine.
Metronidazole: This is a standard antibiotic
Neomycin: This is a standard antibiotic.
Vancomycin: This is a standard antibiotic.
|
IIV Flu Vaccine
n=17 participants at risk
This arm will not take antibiotics in conjunction with IIV.
Arm 1 and Arm 2: Inactivated Flu Vaccine: This is an FDA approved and tested Flu Vaccine.
|
|---|---|---|
|
Blood and lymphatic system disorders
thrombocytopenia
|
12.5%
2/16 • Number of events 2 • 365 days
|
0.00%
0/17 • 365 days
|
|
Gastrointestinal disorders
nausea
|
6.2%
1/16 • Number of events 1 • 365 days
|
0.00%
0/17 • 365 days
|
|
General disorders
abdominal pain
|
18.8%
3/16 • Number of events 3 • 365 days
|
0.00%
0/17 • 365 days
|
|
Blood and lymphatic system disorders
anemia
|
18.8%
3/16 • Number of events 3 • 365 days
|
5.9%
1/17 • Number of events 1 • 365 days
|
|
Blood and lymphatic system disorders
neutropenia
|
6.2%
1/16 • Number of events 1 • 365 days
|
0.00%
0/17 • 365 days
|
|
Blood and lymphatic system disorders
leukopenia
|
6.2%
1/16 • Number of events 1 • 365 days
|
5.9%
1/17 • Number of events 1 • 365 days
|
|
Gastrointestinal disorders
diarrhea
|
12.5%
2/16 • Number of events 2 • 365 days
|
0.00%
0/17 • 365 days
|
|
Skin and subcutaneous tissue disorders
anal itching
|
6.2%
1/16 • Number of events 1 • 365 days
|
0.00%
0/17 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
URI
|
0.00%
0/16 • 365 days
|
5.9%
1/17 • Number of events 1 • 365 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place