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The purpose of the study is to determine the amount of live virus that can be recovered from the nose of people who are vaccinated with the licensed live vaccine against H1N1, and to describe the immune response to vaccination.
By looking at the immune response before and after vaccine, we hope to understand the factors that determine the immune response and detailed shedding patterns of live novel H1N1 vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| live monovalent H1N1 vaccine | Other | A/California/07/09 live monovalent H1N1 vaccine 0.2 given intranasally, 2 doses given 28 days apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A/California/07/09 live monovalent H1N1 vaccine | Biological | 0.1mL per nares intranasally, second identical dose given 28 days after first vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Shed Virus | 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. | 28 days post vaccine 1 and 28 days vaccine 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Difference Between Cycle Time and Detection Threshold | 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. | day 10 post vaccine 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John J. Treanor, M.D. | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vaccine Research Unit Room 3-5000 | Rochester | New York | 14642 | United States |
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)
Healthy Volunteers were recruited from the general public between December 2009 and January 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Live Monovalent H1N1 Vaccine | Subjects received 2 doses of vaccine 0.1 ml in each nostril intranasally 28 days apart |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Live Monovalent H1N1 Vaccine | Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Shed Virus | 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. | per protocol | Posted | Number | participants | 28 days post vaccine 1 and 28 days vaccine 2 |
|
|
56 days
Participants were queried at each visit about the occurence of any adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Live Monovalent H1N1 Vaccine | Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Treanor< M.D. | University of Rochester | 585-275-5871 | john_treanor@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D009976 | Orthomyxoviridae Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Mean Difference Between Cycle Time and Detection Threshold | 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. | per protocol | Posted | Mean | 95% Confidence Interval | cycles | day 10 post vaccine 1 |
|
|
|
| 0 |
| 20 |
| 11 |
| 20 |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Light Headed | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Menstral Cramps | Reproductive system and breast disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Nosebleed | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Runny nose | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Stuffy nose | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Swollen glands | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| URI | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
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| D012140 |
| Respiratory Tract Diseases |