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The purpose of this study is to describe the immune response to a novel H1N1 influenza vaccination in healthy adults, and to understand the factors that allow healthy adults to respond to a single dose of vaccine even if they have never previously experience novel H1N1 disease or vaccination.
Studies have now determined that only a single dose of inactivated vaccine is needed for immunization against novel H1N1, but the reasons why adults appear to be ready to respond to a single dose are not known.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inactivated H1N1 Vaccine | Other | Subject will recieve 0.5 mL IM injection of Inactivated H1N1 vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated H1N1 vaccine | Biological | 0.5 ml IM into Deltoid region of arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of Immune Response to Vaccination. | Number of participants with a 4-fold or greater increase in serum HAI antibody from pre- to 28 day post-vaccination | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the Reactogenicity Events Post Vaccination. | Number of subjects with reactogenicity events of grade 2 or higher within 7 days of vaccination | 7 days |
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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 |
Subjects 18-32 were required to have a serum antibody test done during screening. Their HAI antibody level needed to be less than or = to 1:8. Female subjects of childbearing potential must have a negative pregnancy test at screening.
Subjects were recruited via flyers and advertisments. Recruitment began 12/2009 and ended 10/2010. Subjects were screened via IRB approved Screening script by phone and visit as indicated.
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| ID | Title | Description |
|---|---|---|
| FG000 | H1N1 Monovalent Influenza Vaccine | 0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | H1N1 Monovalent Influenza Vaccine | 0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine |
| 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 | Determination of Immune Response to Vaccination. | Number of participants with a 4-fold or greater increase in serum HAI antibody from pre- to 28 day post-vaccination | All subjects who completed Day 28 visit post vaccination were analyzed. | Posted | Number | participants | 28 days |
|
|
Adverse events both non-serious and serious were collected from Day O (day of vaccination thru day 28. Reactogenicity events were collected on a memory aid from day 0 to day 7.
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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 | H1N1 Monovalent Influenza Vaccine | 0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| UPPER RESPIRATORY INFECTION | Respiratory, thoracic and mediastinal disorders | CTCAEv4_MedRaAv | 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 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Inactivated H1N1 vaccine | Biological | 0.5 mL IM X 1 dose |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Assessment of the Reactogenicity Events Post Vaccination. | Number of subjects with reactogenicity events of grade 2 or higher within 7 days of vaccination | Subjects who completed the 7 day diary card | Posted | Number | participants | 7 days |
|
|
|
| 0 |
| 107 |
| 14 |
| 107 |
| FATIGUE | General disorders | CTCAEv4_MedRaAv | Non-systematic Assessment |
|
| CONGESTION | Respiratory, thoracic and mediastinal disorders | CTCAEv4_MedRaAv | Non-systematic Assessment |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |