Trial Outcomes & Findings for Effects of Age on Response to the 2009 H1N1 Virus Vaccine (NCT NCT01055184)
NCT ID: NCT01055184
Last Updated: 2016-05-30
Results Overview
number of participants who shed virus above the limit of detection at any timepoint after vaccine. The limit of detection is 0.5 tissue culture infectious doses per mL of nasal wash.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
34 participants
Primary outcome timeframe
day 0 to day 7 post vaccination
Results posted on
2016-05-30
Participant Flow
Potential subjects were recruited from 3/24/2010 to 11/17/2010. Potential subjects were seen at the Vaccine research Unit clinic.
Only subjects who did not meet inclusion/exclusion criteria were excluded from participation.
Participant milestones
| Measure |
2009 H1N1 Vaccine
To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Age on Response to the 2009 H1N1 Virus Vaccine
Baseline characteristics by cohort
| Measure |
2009 H1N1 Vaccine
n=34 Participants
To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
|
|---|---|
|
Age, Customized
60-70 years
|
20 participants
n=39 Participants
|
|
Age, Customized
>70 years
|
14 participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: day 0 to day 7 post vaccinationnumber of participants who shed virus above the limit of detection at any timepoint after vaccine. The limit of detection is 0.5 tissue culture infectious doses per mL of nasal wash.
Outcome measures
| Measure |
2009 H1N1 Vaccine
n=34 Participants
To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
|
|---|---|
|
Number of Participants Who Shed Virus
|
0 participants
|
Adverse Events
2009 H1N1 Vaccine
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2009 H1N1 Vaccine
n=34 participants at risk
To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
|
|---|---|
|
Cardiac disorders
Aortic Stenosis
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from day 0 thru Dy 180
|
Other adverse events
| Measure |
2009 H1N1 Vaccine
n=34 participants at risk
To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from day 0 thru Dy 180
|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from day 0 thru Dy 180
|
|
Infections and infestations
Shingles
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from day 0 thru Dy 180
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
8.8%
3/34 • Number of events 3 • Adverse Events were collected from day 0 thru Dy 180
|
|
Musculoskeletal and connective tissue disorders
Achy legs
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from day 0 thru Dy 180
|
|
Ear and labyrinth disorders
Ringing in ears
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from day 0 thru Dy 180
|
|
Musculoskeletal and connective tissue disorders
Bone spurs left shoulder
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from day 0 thru Dy 180
|
|
Infections and infestations
Urinary Tract Infection
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from day 0 thru Dy 180
|
|
Nervous system disorders
Pinched nerve in neck
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from day 0 thru Dy 180
|
|
Musculoskeletal and connective tissue disorders
Lower back pain - left side
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from day 0 thru Dy 180
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place