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To observe and to describe the safety during Days 0 to 21 following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years.
To measure and to describe the immune response (antibodies to hemagglutinin) 21 days following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.
The time of onset and duration of local and systemic solicited reactions will be assessed and reported. Unsolicited adverse events (including serious adverse events) will be collected and categorized throughout the study period.
Antibody levels will be evaluated by hemagglutination inhibition (HI) assay from sera obtained pre-vaccination (Day 0) and 21 days post-vaccination, for antigens from the 2004-2005 influenza virus strains: A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2), and B/Jiangsu/10/2003.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluzone® Vaccine Group - Age 18-59 Years | Experimental | Participants aged 18 to 59 years at enrollment and received 1 dose of Fluzone® Vaccine |
|
| Fluzone® Vaccine Group - Age ≥ 60 Years | Experimental | Participants aged at least 60 years or older at enrollment and received 1 dose of Fluzone® Vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzone®: Influenza virus vaccine 2004-2005 formulation | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination | Solicited local reactions: Erythema (redness), Induration, Bruising, and Pain at the injection site. Solicited systemic events: Fever (temperature), Chills, Rash, Headache, Cough, Runny nose, Nausea, Vomiting, Diarrhea, Malaise, Myalgia, and Arthralgia | 0 to 3 days post-vaccination |
| Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine | GMTs and their 95% Confidence Intervals for each of the 3 antigens pre- and post-vaccination with Fluzone® 2004-2005 formulation. | Day 0 and Day 21 Post-Vaccination |
| Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination | 21 Days post-vaccination | |
| Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination | Day 21 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 120 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
The study participants were enrolled from 06 through 16 August 2004 in 1 US site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluzone® Vaccine Group - Age 18-59 Years | Participants received 1 dose of Fluzone® vaccine on Day 0. |
| FG001 | Fluzone® Vaccine Group - Age ≥ 60 Years | Participants received 1 dose of Fluzone® vaccine on Day 0. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Fluzone®: Influenza virus vaccine 2004-2005 formulation | Biological | 0.5 mL, Intramuscular |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluzone® Vaccine Group - Age 18-59 Years | Participants received 1 dose of Fluzone® vaccine on Day 0. |
| BG001 | Fluzone® Vaccine Group - Age ≥ 60 Years | Participants received 1 dose of Fluzone® vaccine on Day 0. |
| 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 Local and Systemic Reactions After Fluzone® Vaccination | Solicited local reactions: Erythema (redness), Induration, Bruising, and Pain at the injection site. Solicited systemic events: Fever (temperature), Chills, Rash, Headache, Cough, Runny nose, Nausea, Vomiting, Diarrhea, Malaise, Myalgia, and Arthralgia | Posted | Number | Percentage of Participants | 0 to 3 days post-vaccination |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine | GMTs and their 95% Confidence Intervals for each of the 3 antigens pre- and post-vaccination with Fluzone® 2004-2005 formulation. | Geometric Mean Titers were assessed in the per-protocol population | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 and Day 21 Post-Vaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination | Posted | Number | Percentage of Participants | 21 Days post-vaccination |
|
| |||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination | Posted | Number | Percentage of Participants | Day 21 post-vaccination |
|
|
Adverse events data were collected from the day of vaccination for 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 | Fluzone® Vaccine Group - Age 18-59 Years | Participants received 1 dose of Fluzone® vaccine on Day 0. | 0 | 60 | 60 | 60 | ||
| EG001 | Fluzone® Vaccine Group - Age ≥ 60 Years | Participants received 1 dose of Fluzone® vaccine on Day 0. | 1 | 60 | 20 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Diarrhoea NOS | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Rhinorrhoea (Runny nose) | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | 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 Erythema (≥ 5.0 cm) |
|
| Any Induration (> 0.5 cm) |
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| Grade 3 Induration (≥ 5.0 cm) |
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| Any Bruising (> 0.5 cm) |
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| Grade 3 Bruising (≥ 5.0 cm) |
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| Any Pain |
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| Grade 3 Pain (unable to perform usual activities) |
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| Any Solicited Systemic Reaction |
|
| Any Fever (≥ 100.4 º F) |
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| Grade 3 Fever (≥ 104.0 º F) |
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| Any Headache |
|
| Grade 3 Headache (prevents daily activity) |
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| Any Chills |
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| Grade 3 Chills (prevents daily activity) |
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| Any Cough |
|
| Grade 3 Cough (prevents daily activity) |
|
| Any Runny Nose |
|
| Grade 3 Runny Nose (prevents daily activity) |
|
| Any Rash |
|
| Grade 3 Rash (prevents daily activity) |
|
| Any Malaise |
|
| Grade 3 Malaise (prevents daily activity) |
|
| Any Myalgia |
|
| Grade 3 Myalgia (prevents daily activity) |
|
| Any Arthralgia |
|
| Grade 3 Arthralgia (prevents daily activity) |
|
| Any Nausea |
|
| Grade 3 Nausea (prevents daily activity) |
|
| Any Vomiting |
|
| Grade 3 Vomiting (≥ 3 per day) |
|
| Any Diarrhea |
|
| Grade 3 Diarrhea (≥ 5 episodes per day) |
|
|
|
|