Trial Outcomes & Findings for Flu Vaccine Study in Neuromuscular Patients 2011 (NCT NCT01422200)
NCT ID: NCT01422200
Last Updated: 2020-10-19
Results Overview
Serum HI antibody titers for each vaccine strain immediately prior to study vaccine receipt and 21-28 days after study vaccine receipt
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
immediately before vaccination and 21-28 days after vaccination
Results posted on
2020-10-19
Participant Flow
Participant milestones
| Measure |
Subcutaneous
2011-2012 Northern Hemisphere formulation trivalent inactivated influenza vaccine
|
Intramuscular
2011-2012 Northern Hemisphere formulation trivalent inactivated influenza vaccine
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Flu Vaccine Study in Neuromuscular Patients 2011
Baseline characteristics by cohort
| Measure |
Subcutaneous
n=11 Participants
2011-2012 Northern Hemisphere formulation inactivated influenza vaccine
|
Intramuscular
n=11 Participants
2011-2012 Northern Hemisphere formulation inactivated influenza vaccine
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
18.20 years
STANDARD_DEVIATION 4.88 • n=5 Participants
|
19.37 years
STANDARD_DEVIATION 4.23 • n=7 Participants
|
18.78 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: immediately before vaccination and 21-28 days after vaccinationSerum HI antibody titers for each vaccine strain immediately prior to study vaccine receipt and 21-28 days after study vaccine receipt
Outcome measures
| Measure |
Subcutaneous
n=11 Participants
Subjects receiving 2011-2012 Northern Hemisphere trivalent inactivated influenza vaccine by subcutaneous route
|
Intramuscular
n=11 Participants
Subjects receiving 2011-2012 Northern Hemisphere trivalent inactivated influenza vaccine
|
|---|---|---|
|
Geometric Mean Titer Ratio for Each Vaccine Strain
HINI vaccine strain
|
3.76 geometric mean titer ratio
Interval 2.31 to 6.11
|
3.53 geometric mean titer ratio
Interval 1.43 to 8.7
|
|
Geometric Mean Titer Ratio for Each Vaccine Strain
H3N2 vaccine strain
|
2 geometric mean titer ratio
Interval 1.49 to 2.68
|
1.46 geometric mean titer ratio
Interval 0.94 to 2.25
|
|
Geometric Mean Titer Ratio for Each Vaccine Strain
B vaccine strain
|
1.76 geometric mean titer ratio
Interval 1.24 to 2.5
|
2 geometric mean titer ratio
Interval 1.11 to 3.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 days following receipt of study vaccinePopulation: Subjects who completed the diary sheets
For the 4 days following receipt of study vaccine (days 0 to 4), the following local reactions will be assessed: pain, redness, and swelling. The following systemic reactions will also be assessed: body ache, weakness, irritability, headache, and cough.
Outcome measures
| Measure |
Subcutaneous
n=8 Participants
Subjects receiving 2011-2012 Northern Hemisphere trivalent inactivated influenza vaccine by subcutaneous route
|
Intramuscular
n=10 Participants
Subjects receiving 2011-2012 Northern Hemisphere trivalent inactivated influenza vaccine
|
|---|---|---|
|
Safety: Summary of Local and Systemic Reactogenicity Symptoms
Pain
|
4 Participants
|
5 Participants
|
|
Safety: Summary of Local and Systemic Reactogenicity Symptoms
Redness
|
1 Participants
|
1 Participants
|
|
Safety: Summary of Local and Systemic Reactogenicity Symptoms
Swelling
|
2 Participants
|
1 Participants
|
|
Safety: Summary of Local and Systemic Reactogenicity Symptoms
Body ache
|
0 Participants
|
1 Participants
|
|
Safety: Summary of Local and Systemic Reactogenicity Symptoms
Weakness
|
0 Participants
|
1 Participants
|
|
Safety: Summary of Local and Systemic Reactogenicity Symptoms
Irritabiltity
|
0 Participants
|
1 Participants
|
|
Safety: Summary of Local and Systemic Reactogenicity Symptoms
Headache
|
1 Participants
|
0 Participants
|
|
Safety: Summary of Local and Systemic Reactogenicity Symptoms
Cough
|
0 Participants
|
1 Participants
|
Adverse Events
Intramuscular
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Subcutaneous
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intramuscular
n=11 participants at risk
2011-2012 Northern Hemisphere formulation trivalent inactivated influenza vaccine administered once intramuscularly
|
Subcutaneous
n=11 participants at risk
2011-2012 Northern Hemisphere formulation trivalent inactivated influenza vaccine administered once via subcutaneous route
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Paine/tenderness
|
45.5%
5/11 • Local and systemic adverse events were collected on diary sheets from day 0 to day 4 after vaccination. Serious adverse events were collected through the final study visit, about 28 days.
Within 30 minutes of vaccination, subjects rated the painfulness using a picture or numeric pain scale. Subjects and their caregivers were also asked to record local and systemic adverse events on diary sheets from day 0 to day 4 after vaccination. A mild symptom is one which is easily tolerated, a moderate symptom causes interference with usual daily activities, and a severe symptom results in the inability to perform daily activities.
|
36.4%
4/11 • Local and systemic adverse events were collected on diary sheets from day 0 to day 4 after vaccination. Serious adverse events were collected through the final study visit, about 28 days.
Within 30 minutes of vaccination, subjects rated the painfulness using a picture or numeric pain scale. Subjects and their caregivers were also asked to record local and systemic adverse events on diary sheets from day 0 to day 4 after vaccination. A mild symptom is one which is easily tolerated, a moderate symptom causes interference with usual daily activities, and a severe symptom results in the inability to perform daily activities.
|
|
Skin and subcutaneous tissue disorders
Redness
|
9.1%
1/11 • Local and systemic adverse events were collected on diary sheets from day 0 to day 4 after vaccination. Serious adverse events were collected through the final study visit, about 28 days.
Within 30 minutes of vaccination, subjects rated the painfulness using a picture or numeric pain scale. Subjects and their caregivers were also asked to record local and systemic adverse events on diary sheets from day 0 to day 4 after vaccination. A mild symptom is one which is easily tolerated, a moderate symptom causes interference with usual daily activities, and a severe symptom results in the inability to perform daily activities.
|
9.1%
1/11 • Local and systemic adverse events were collected on diary sheets from day 0 to day 4 after vaccination. Serious adverse events were collected through the final study visit, about 28 days.
Within 30 minutes of vaccination, subjects rated the painfulness using a picture or numeric pain scale. Subjects and their caregivers were also asked to record local and systemic adverse events on diary sheets from day 0 to day 4 after vaccination. A mild symptom is one which is easily tolerated, a moderate symptom causes interference with usual daily activities, and a severe symptom results in the inability to perform daily activities.
|
|
Skin and subcutaneous tissue disorders
Swelling
|
9.1%
1/11 • Local and systemic adverse events were collected on diary sheets from day 0 to day 4 after vaccination. Serious adverse events were collected through the final study visit, about 28 days.
Within 30 minutes of vaccination, subjects rated the painfulness using a picture or numeric pain scale. Subjects and their caregivers were also asked to record local and systemic adverse events on diary sheets from day 0 to day 4 after vaccination. A mild symptom is one which is easily tolerated, a moderate symptom causes interference with usual daily activities, and a severe symptom results in the inability to perform daily activities.
|
18.2%
2/11 • Local and systemic adverse events were collected on diary sheets from day 0 to day 4 after vaccination. Serious adverse events were collected through the final study visit, about 28 days.
Within 30 minutes of vaccination, subjects rated the painfulness using a picture or numeric pain scale. Subjects and their caregivers were also asked to record local and systemic adverse events on diary sheets from day 0 to day 4 after vaccination. A mild symptom is one which is easily tolerated, a moderate symptom causes interference with usual daily activities, and a severe symptom results in the inability to perform daily activities.
|
|
General disorders
Body Ache
|
9.1%
1/11 • Local and systemic adverse events were collected on diary sheets from day 0 to day 4 after vaccination. Serious adverse events were collected through the final study visit, about 28 days.
Within 30 minutes of vaccination, subjects rated the painfulness using a picture or numeric pain scale. Subjects and their caregivers were also asked to record local and systemic adverse events on diary sheets from day 0 to day 4 after vaccination. A mild symptom is one which is easily tolerated, a moderate symptom causes interference with usual daily activities, and a severe symptom results in the inability to perform daily activities.
|
0.00%
0/11 • Local and systemic adverse events were collected on diary sheets from day 0 to day 4 after vaccination. Serious adverse events were collected through the final study visit, about 28 days.
Within 30 minutes of vaccination, subjects rated the painfulness using a picture or numeric pain scale. Subjects and their caregivers were also asked to record local and systemic adverse events on diary sheets from day 0 to day 4 after vaccination. A mild symptom is one which is easily tolerated, a moderate symptom causes interference with usual daily activities, and a severe symptom results in the inability to perform daily activities.
|
|
General disorders
Weakness
|
9.1%
1/11 • Local and systemic adverse events were collected on diary sheets from day 0 to day 4 after vaccination. Serious adverse events were collected through the final study visit, about 28 days.
Within 30 minutes of vaccination, subjects rated the painfulness using a picture or numeric pain scale. Subjects and their caregivers were also asked to record local and systemic adverse events on diary sheets from day 0 to day 4 after vaccination. A mild symptom is one which is easily tolerated, a moderate symptom causes interference with usual daily activities, and a severe symptom results in the inability to perform daily activities.
|
0.00%
0/11 • Local and systemic adverse events were collected on diary sheets from day 0 to day 4 after vaccination. Serious adverse events were collected through the final study visit, about 28 days.
Within 30 minutes of vaccination, subjects rated the painfulness using a picture or numeric pain scale. Subjects and their caregivers were also asked to record local and systemic adverse events on diary sheets from day 0 to day 4 after vaccination. A mild symptom is one which is easily tolerated, a moderate symptom causes interference with usual daily activities, and a severe symptom results in the inability to perform daily activities.
|
|
Skin and subcutaneous tissue disorders
Irritability
|
9.1%
1/11 • Local and systemic adverse events were collected on diary sheets from day 0 to day 4 after vaccination. Serious adverse events were collected through the final study visit, about 28 days.
Within 30 minutes of vaccination, subjects rated the painfulness using a picture or numeric pain scale. Subjects and their caregivers were also asked to record local and systemic adverse events on diary sheets from day 0 to day 4 after vaccination. A mild symptom is one which is easily tolerated, a moderate symptom causes interference with usual daily activities, and a severe symptom results in the inability to perform daily activities.
|
0.00%
0/11 • Local and systemic adverse events were collected on diary sheets from day 0 to day 4 after vaccination. Serious adverse events were collected through the final study visit, about 28 days.
Within 30 minutes of vaccination, subjects rated the painfulness using a picture or numeric pain scale. Subjects and their caregivers were also asked to record local and systemic adverse events on diary sheets from day 0 to day 4 after vaccination. A mild symptom is one which is easily tolerated, a moderate symptom causes interference with usual daily activities, and a severe symptom results in the inability to perform daily activities.
|
|
Nervous system disorders
Headache
|
0.00%
0/11 • Local and systemic adverse events were collected on diary sheets from day 0 to day 4 after vaccination. Serious adverse events were collected through the final study visit, about 28 days.
Within 30 minutes of vaccination, subjects rated the painfulness using a picture or numeric pain scale. Subjects and their caregivers were also asked to record local and systemic adverse events on diary sheets from day 0 to day 4 after vaccination. A mild symptom is one which is easily tolerated, a moderate symptom causes interference with usual daily activities, and a severe symptom results in the inability to perform daily activities.
|
9.1%
1/11 • Local and systemic adverse events were collected on diary sheets from day 0 to day 4 after vaccination. Serious adverse events were collected through the final study visit, about 28 days.
Within 30 minutes of vaccination, subjects rated the painfulness using a picture or numeric pain scale. Subjects and their caregivers were also asked to record local and systemic adverse events on diary sheets from day 0 to day 4 after vaccination. A mild symptom is one which is easily tolerated, a moderate symptom causes interference with usual daily activities, and a severe symptom results in the inability to perform daily activities.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Local and systemic adverse events were collected on diary sheets from day 0 to day 4 after vaccination. Serious adverse events were collected through the final study visit, about 28 days.
Within 30 minutes of vaccination, subjects rated the painfulness using a picture or numeric pain scale. Subjects and their caregivers were also asked to record local and systemic adverse events on diary sheets from day 0 to day 4 after vaccination. A mild symptom is one which is easily tolerated, a moderate symptom causes interference with usual daily activities, and a severe symptom results in the inability to perform daily activities.
|
0.00%
0/11 • Local and systemic adverse events were collected on diary sheets from day 0 to day 4 after vaccination. Serious adverse events were collected through the final study visit, about 28 days.
Within 30 minutes of vaccination, subjects rated the painfulness using a picture or numeric pain scale. Subjects and their caregivers were also asked to record local and systemic adverse events on diary sheets from day 0 to day 4 after vaccination. A mild symptom is one which is easily tolerated, a moderate symptom causes interference with usual daily activities, and a severe symptom results in the inability to perform daily activities.
|
Additional Information
Dr. Brenda Wong
Cincinnati Children's Hospital Medical Center
Phone: 5136364222
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place