Trial Outcomes & Findings for Responses to Influenza Vaccine in Patients With Mitochondrial Disorders (MELAS) (NCT NCT01831934)
NCT ID: NCT01831934
Last Updated: 2017-05-30
Results Overview
We will measure solicited local and systemic adverse events and SAEs for 1 month following immunization
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
Day 0 to Day28
Results posted on
2017-05-30
Participant Flow
Participant milestones
| Measure |
MELAS Group:13-60 Years of Age.
Fluzone® 2011-2012 Formula
Fluzone® 2011-2012 Formula: Quadrivalent inactivated influenza vaccine given given intramuscularly in 0.5ml doses.
|
Control Group: 18-65 Years of Age
Fluzone® 2011-2012 Formula
Fluzone® 2011-2012 Formula: Quadrivalent inactivated influenza vaccine given given intramuscularly in 0.5ml doses.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Responses to Influenza Vaccine in Patients With Mitochondrial Disorders (MELAS)
Baseline characteristics by cohort
| Measure |
MELAS Group
n=12 Participants
Fluzone®
Fluzone®
|
Control Group
n=10 Participants
Fluzone®
Fluzone®
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.74 years
STANDARD_DEVIATION 8.06 • n=39 Participants
|
37.39 years
STANDARD_DEVIATION 10.04 • n=41 Participants
|
38.13 years
STANDARD_DEVIATION 8.99 • n=35 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=39 Participants
|
10 participants
n=41 Participants
|
22 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day28We will measure solicited local and systemic adverse events and SAEs for 1 month following immunization
Outcome measures
| Measure |
MELAS Group
n=12 Participants
Fluzone® 2011-2012 Formula
Fluzone® 2011-2012 Formula: This vaccine is given intramuscularly
|
Control Group
n=10 Participants
Fluzone® 2011-2012 Formula
Fluzone® 2011-2012 Formula: This vaccine is given intramuscularly
|
|---|---|---|
|
Clinical Safety of TIV Vaccine
Number of Adverse Events
|
4 Participants
|
0 Participants
|
|
Clinical Safety of TIV Vaccine
Number of Severe Adverse Events
|
0 Participants
|
0 Participants
|
|
Clinical Safety of TIV Vaccine
Number with no Adverse Events
|
8 Participants
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0-Day28This method relies on the ability of intracellular glutathione S-transferases to tag GSH to bimane to yield a bimane-GS conjugate that fluoresces at 440 nm.
Outcome measures
Outcome data not reported
Adverse Events
MELAS Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Control Group
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 |
MELAS Group
n=12 participants at risk
Fluzone®
Fluzone®
|
Control Group
n=10 participants at risk
Fluzone®
Fluzone®
|
|---|---|---|
|
Nervous system disorders
Seizure
|
8.3%
1/12 • Number of events 3 • 30 days post immunization
|
0.00%
0/10 • 30 days post immunization
|
|
General disorders
Nasal Discharge
|
16.7%
2/12 • Number of events 2 • 30 days post immunization
|
0.00%
0/10 • 30 days post immunization
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasm
|
8.3%
1/12 • Number of events 1 • 30 days post immunization
|
0.00%
0/10 • 30 days post immunization
|
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