Trial Outcomes & Findings for The Influence of Chronic CMV Infection on Influenza Vaccine Responses (NCT NCT02134184)
NCT ID: NCT02134184
Last Updated: 2023-04-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
78 participants
Primary outcome timeframe
Day 0 to Day 28
Results posted on
2023-04-19
Participant Flow
Participant milestones
| Measure |
CMV Negative Group
Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly
|
CMV Positive Group
Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly
|
Recent CMV Converters
Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly Recent CMV Conversion is defined as: Donor has donated at least once within the "recent" timeframe (past three years) AND donor's most recent two donations tested CMV antibody positive AND donor had at least two CMV negative donations in the past
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
37
|
8
|
|
Overall Study
COMPLETED
|
33
|
37
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Influence of Chronic CMV Infection on Influenza Vaccine Responses
Baseline characteristics by cohort
| Measure |
CMV Negative Group
n=33 Participants
Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly
|
CMV Positive Group
n=37 Participants
Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly
|
Recent CMV Converters
n=8 Participants
Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly
|
Total
n=78 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Age, Continuous
|
66.96 years
STANDARD_DEVIATION 4.52 • n=5 Participants
|
67.46 years
STANDARD_DEVIATION 5.26 • n=7 Participants
|
66.75 years
STANDARD_DEVIATION 3.53 • n=5 Participants
|
67.21 years
STANDARD_DEVIATION 4.80 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 28Outcome measures
| Measure |
CMV Negative Group
n=33 Participants
Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly
|
CMV Positive Group
n=37 Participants
Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly
|
Recent CMV Converters
n=8 Participants
Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly
|
|---|---|---|---|
|
Number of Participants From Each Arm Who Received Influenza Vaccine
|
33 Participants
|
37 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 0 to Day 28Outcome measures
| Measure |
CMV Negative Group
n=33 Participants
Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly
|
CMV Positive Group
n=37 Participants
Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly
|
Recent CMV Converters
n=8 Participants
Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly
|
|---|---|---|---|
|
Number of Participants With Related Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 to Day 28Outcome measures
Outcome data not reported
Adverse Events
CMV Negative Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
CMV Positive Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Recent CMV Converters
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CMV Negative Group
n=33 participants at risk
Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly
|
CMV Positive Group
n=37 participants at risk
Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly
|
Recent CMV Converters
n=8 participants at risk
Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.0%
1/33 • Number of events 1 • Day 0 to Day 28 of study participation
Clinical Assessment performed at each visit
|
0.00%
0/37 • Day 0 to Day 28 of study participation
Clinical Assessment performed at each visit
|
0.00%
0/8 • Day 0 to Day 28 of study participation
Clinical Assessment performed at each visit
|
Additional Information
Dr Cornelia Dekker
Stanford University School of Medicine, Dept. of Pediatrics
Phone: 650-724-4437
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place