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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 |
|---|---|---|---|
| 1 | Experimental | aged 19 to 59 years |
|
| 2 | Experimental | aged ≥ 60 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Virus Vaccine (2006-2007 Fluzone® vaccine) | Biological | Influenza vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Percentage of Participants with Solicited Injection Site or Systemic Reaction(s) within 0-3 days after vaccination with Fluzone® (2006-2007 formulation) | 0-3 days post-vaccination |
| Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination | GMTs and their 95% confidence intervals for each of the 3 antigens in the Fluzone® vaccine (2006-2007 formulation) pre-vaccination and 21 days post-vaccination. | 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 116 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
Study participants were enrolled from October through December 2006 in 1 medical clinic in the US
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| ID | Title | Description |
|---|---|---|
| FG000 | Aged 18 to 59 Years | Participants aged 18 to 59 years at enrollment |
| FG001 | Aged ≥ 60 Years | Participants aged 60 years and older at enrollment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Influenza Virus Vaccine (2006-2007 Fluzone® vaccine) | Biological | Influenza vaccine |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aged 18 to 59 Years | Participants aged 18 to 59 years at enrollment |
| BG001 | Aged ≥ 60 Years | Participants aged 60 years and older at enrollment |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Percentage of Participants with Solicited Injection Site or Systemic Reaction(s) within 0-3 days after vaccination with Fluzone® (2006-2007 formulation) | Analysis was on all enrolled and vaccinated participants, Intend-to-treat population. | Posted | Number | Percentage of Participants | 0-3 days post-vaccination |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination | GMTs and their 95% confidence intervals for each of the 3 antigens in the Fluzone® vaccine (2006-2007 formulation) pre-vaccination and 21 days post-vaccination. | Geometric Mean Titers were evaluated in the per-protocol immunogenicity Population | Posted | Geometric Mean | 95% Confidence Interval | Titer | 21 days post-vaccination |
|
|
Up to 28 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 | Aged 18 to 59 Years | Participants aged 18 to 59 years at enrollment | 0 | 60 | 15 | 60 | ||
| EG001 | Aged ≥ 60 Years | Participants aged 60 years and older at enrollment | 0 | 56 | 2 | 56 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi pasteur Inc | RegistryContactUS@sanofipasteur.com |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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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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| >=65 years |
|
| Male |
|
| Grade 3 Pain (Incapacitating) |
|
| Any Redness |
|
| Grade 3 Redness (≥ 5.0 cm) |
|
| Any Swelling |
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| Grade 3 Swelling (≥ 5.0 cm) |
|
| Any Solicited Systemic Reaction |
|
| Any Fever |
|
| Grade 3 Fever (> 102.2°F) |
|
| Any Headache |
|
| Grade 3 Headache (Prevented daily activities) |
|
| Any Malaise |
|
| Grade 3 Malaise (Prevented daily activities) |
|
| Any Myalgia |
|
| Grade 3 Myalgia (Prevented daily activities) |
|
|