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The goal of this research is to find out how the body's immune system responds to different manufacturer's "flu" vaccines.
There are currently five licensed inactivated influenza vaccines approved for use in the United States by the Food and Drug Administration.Current influenza virus vaccines consist of 3 components: the HA protein from an H1N1 virus, an H3N2 and an influenza B virus.Influenza vaccines are evaluated and approved by the FDA on the basis of HA and NA content. However, different manufacturing processes are involved in the preparation of these commercial vaccines and evidence suggests that each of these vaccines contain similar patterns of HA protein but different patterns of influenza influenza internal proteins such as NP and M1. The presence of these additional internal proteins of influenza virus which are targets of T cell responses suggest not only the potential for additional protection derived from influenza vaccines other than antibody mediated protection but also differential levels of T cell mediated protection between different manufacturers of commercial influenza vaccines.Each subject will have four blood samples taken- prevaccination and at Days 7, 14,30 and 3-5 months post vaccination. These samples will be tested for T and B cell responses and the results compared between different manufacturers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flulaval | Active Comparator |
| |
| Fluvirin | Active Comparator |
| |
| Fluzone | Active Comparator |
| |
| Fluarix | Active Comparator |
| |
| Affluria | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flulaval | Biological | one 0.5-mL dose via intramuscular injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| T Cell Responses Following Immunization | Comparison of mean peak fold increases in ELISPOT H1N1, H3N2, and B responses between different vaccine groups | Prevaccination and approximately 7 days,14 days ,1month and up to 3-5 months post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Responses Following Immunization | Geometric mean fold rise in antibody titer between day 0 ( baseline) and approximately 1 month post vaccination within each vaccine group | Prevaccination and approximately 1 month post vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Dawn T Co, MD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Medical School | Worcester | Massachusetts | 01605 | United States |
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We recruited healthy adults subjects during the 2008-2009, 2009-2010, 2010-2011, and 2011-2012 influenza seasons in a clinical research setting.
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| ID | Title | Description |
|---|---|---|
| FG000 | Flulaval | Flulaval: one 0.5-mL dose via intramuscular injection |
| FG001 | Fluvirin | Fluvirin: one 0.5-mL dose via intramuscular injection |
| FG002 | Fluzone | Fluzone: one 0.5-mL dose via intramuscular injection |
| FG003 | Fluarix | Fluarix: one 0.5-mL dose via intramuscular injection |
| FG004 | Afluria | Afluria: one 0.5-mL dose via intramuscular injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Flulaval | Flulaval: one 0.5-mL dose via intramuscular injection |
| BG001 | Fluvirin | Fluvirin: one 0.5-mL dose via intramuscular injection |
| 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 | T Cell Responses Following Immunization | Comparison of mean peak fold increases in ELISPOT H1N1, H3N2, and B responses between different vaccine groups | Data was collected only for participants from the 2008-2009 influenza season. Data was not collected for Flulaval group.Only participants with evaluable data were included in the analysis. | Posted | Mean | Standard Deviation | fold change | Prevaccination and approximately 7 days,14 days ,1month and up to 3-5 months post vaccination |
|
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Only participants with available data were included in the analysis.
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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 | Flulaval | Flulaval: one 0.5-mL dose via intramuscular injection | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Co | University of Massachusetts Medical School | 5088562927 | mary.co@umassmed.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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| ID | Term |
|---|---|
| C517981 | FluLaval |
| D007252 | Influenza Vaccines |
| C510903 | fluarix |
| C000613428 | Afluria |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Fluvirin |
| Biological |
one 0.5-mL dose via intramuscular injection |
|
| Fluzone | Biological | one 0.5-mL dose via intramuscular injection |
|
| Fluarix | Biological | one 0.5-mL dose via intramuscular injection |
|
| Afluria | Biological | one 0.5-mL dose via intramuscular injection |
|
| Lost to Follow-up |
|
| BG002 | Fluzone | Fluzone: one 0.5-mL dose via intramuscular injection |
| BG003 | Fluarix | Fluarix: one 0.5-mL dose via intramuscular injection |
| BG004 | Afluria | Afluria: one 0.5-mL dose via intramuscular injection |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Fluzone | Fluzone: one 0.5-mL dose via intramuscular injection |
| OG003 | Fluarix | Fluarix: one 0.5-mL dose via intramuscular injection |
| OG004 | Afluria | Afluria: one 0.5-mL dose via intramuscular injection |
|
|
| Secondary | Antibody Responses Following Immunization | Geometric mean fold rise in antibody titer between day 0 ( baseline) and approximately 1 month post vaccination within each vaccine group | Data was collected only for participants from the 2008-2009 influenza season. Data was not collected for the flulaval group. Only participants with evaluable data were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | fold change | Prevaccination and approximately 1 month post vaccination |
|
|
|
| 52 |
| 0 |
| 52 |
| 30 |
| 52 |
| EG001 | Fluvirin | Fluvirin: one 0.5-mL dose via intramuscular injection | 0 | 34 | 0 | 34 | 24 | 34 |
| EG002 | Fluzone | Fluzone: one 0.5-mL dose via intramuscular injection | 0 | 53 | 0 | 53 | 32 | 53 |
| EG003 | Fluarix | Fluarix: one 0.5-mL dose via intramuscular injection | 0 | 11 | 0 | 11 | 6 | 11 |
| EG004 | Afluria | Afluria: one 0.5-mL dose via intramuscular injection | 0 | 36 | 0 | 36 | 25 | 36 |
| Injection site soreness/tenderness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Arm soreness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Soreness or tenderness |
|
| Sore throat | Gastrointestinal disorders | Non-systematic Assessment | Scratchy or sore throat |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Runny nose | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Joint pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Includes neck, back, shoulder pain |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders |
|
| Sniffles | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Muscle stiffness/achiness/pain | Musculoskeletal and connective tissue disorders |
|
| Abdominal pain | Gastrointestinal disorders | abdominal pain or cramps |
|
| " Cold symptoms" | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| fevers | Infections and infestations | fevers, feverish, |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| injection site swelling | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| sweats | Metabolism and nutrition disorders | Non-systematic Assessment |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| H3N2 |
|
| B |
|