Trial Outcomes & Findings for Infectivity, Replication & Immunogenicity of Live nH1N1 Vaccine (NCT NCT01023776)
NCT ID: NCT01023776
Last Updated: 2015-12-23
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.
COMPLETED
PHASE4
20 participants
28 days post vaccine 1 and 28 days vaccine 2
2015-12-23
Participant Flow
Healthy Volunteers were recruited from the general public between December 2009 and January 2010
28 volunteers were recruited; 20 were enrolled and received at least 1 dose of vaccine, 8 were excluded (2 refused further participation and 6 did not meet inclusion criteria #2)
Participant milestones
| Measure |
Live Monovalent H1N1 Vaccine
Subjects received 2 doses of vaccine 0.1 ml in each nostril intranasally 28 days apart
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Infectivity, Replication & Immunogenicity of Live nH1N1 Vaccine
Baseline characteristics by cohort
| Measure |
Live Monovalent H1N1 Vaccine
n=20 Participants
Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
26.8 years
STANDARD_DEVIATION 3.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days post vaccine 1 and 28 days vaccine 2Population: per protocol
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.
Outcome measures
| Measure |
Live Monovalent H1N1 Vaccine
n=20 Participants
Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart
|
|---|---|
|
Number of Participants Who Shed Virus
|
0 participants
|
SECONDARY outcome
Timeframe: day 10 post vaccine 1Population: per protocol
The mean difference was calculated by real-time polymerase chain reaction (PCR) on nasal wash samples. Cycle time is the cycle number at which the PCR reaction is positive with a range of 0-40 cycles. The detection threshold is 40 cycles.
Outcome measures
| Measure |
Live Monovalent H1N1 Vaccine
n=20 Participants
Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart
|
|---|---|
|
Mean Difference Between Cycle Time and Detection Threshold
|
0.0075 cycles
Interval 0.001 to 0.01
|
Adverse Events
Live Monovalent H1N1 Vaccine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Live Monovalent H1N1 Vaccine
n=20 participants at risk
Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Number of events 1 • 56 days
Participants were queried at each visit about the occurence of any adverse events.
|
|
Hepatobiliary disorders
Cholelithiasis
|
5.0%
1/20 • Number of events 1 • 56 days
Participants were queried at each visit about the occurence of any adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • 56 days
Participants were queried at each visit about the occurence of any adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
2/20 • Number of events 2 • 56 days
Participants were queried at each visit about the occurence of any adverse events.
|
|
Nervous system disorders
Light Headed
|
5.0%
1/20 • Number of events 1 • 56 days
Participants were queried at each visit about the occurence of any adverse events.
|
|
Reproductive system and breast disorders
Menstral Cramps
|
5.0%
1/20 • Number of events 2 • 56 days
Participants were queried at each visit about the occurence of any adverse events.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Number of events 2 • 56 days
Participants were queried at each visit about the occurence of any adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nosebleed
|
10.0%
2/20 • Number of events 2 • 56 days
Participants were queried at each visit about the occurence of any adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose
|
10.0%
2/20 • Number of events 2 • 56 days
Participants were queried at each visit about the occurence of any adverse events.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
15.0%
3/20 • Number of events 3 • 56 days
Participants were queried at each visit about the occurence of any adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
20.0%
4/20 • Number of events 5 • 56 days
Participants were queried at each visit about the occurence of any adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Stuffy nose
|
5.0%
1/20 • Number of events 2 • 56 days
Participants were queried at each visit about the occurence of any adverse events.
|
|
Blood and lymphatic system disorders
Swollen glands
|
10.0%
2/20 • Number of events 2 • 56 days
Participants were queried at each visit about the occurence of any adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
URI
|
5.0%
1/20 • Number of events 1 • 56 days
Participants were queried at each visit about the occurence of any adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 1 • 56 days
Participants were queried at each visit about the occurence of any adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place