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Objective 1:To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere (NH) 2007-2008 formulation.
Objective 2: To describe the immunogenicity, of Fluzone, inactivated, split virion influenza vaccine NH 2007-2008 formulation.
Objective 3: Serum Collection - To submit remaining available sera to Center for Biologics Evaluation and research (CBER) for further analysis by the Food and Drug Administration (FDA), the Center for Disease Control and Prevention (CDC), and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated, Split-Virion Influenza Virus | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Information concerning the safety of FluzoneĀ® vaccine 2007-2008 formulation. | 0-3 days post-vaccination and entire study duration |
| Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination. | GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the FluzoneĀ® Vaccine 2007-2008 formulation. | 21 days post-vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norfolk | Virginia | 23507 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 124 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants were recruited from 15 August to 24 September 2007 at one US clinic site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | All participants enrolled and received FluzoneĀ® Vaccine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | All participants enrolled and received FluzoneĀ® 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 | Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Information concerning the safety of FluzoneĀ® vaccine 2007-2008 formulation. | Safety analysis was on all enrolled and vaccinated participants, intend-to-treat Population. | Posted | Number | Participants | 0-3 days post-vaccination and entire study duration |
|
|
Adverse events data were collected from the day of vaccination to 21 days post-vaccination.
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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 | Study Group | All participants enrolled and received FluzoneĀ® Vaccine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc | RegistryContactUs@sanofipasteur.com |
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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 |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination. | GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the FluzoneĀ® Vaccine 2007-2008 formulation. | The GMT were evaluated in the per-protocol Population | Posted | Geometric Mean | 95% Confidence Interval | Titer | 21 days post-vaccination |
|
|
|
| 0 |
| 124 |
| 57 |
| 124 |
| Injection site redness | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Title | Measurements |
|---|---|
|
| H3N2 A/Wisconsin/67/2005 - POST |
|
| B/Malaysia/2506/2004 - PRE |
|
| B/Malaysia/2506/2004 - POST |
|