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To describe the safety during days 0 to 21 following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years.
To describe the immune response at 21 days following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.
Safety will be assessed throughout the trial period. Using antigens provided by Aventis Pasteur Inc., pre- and post-vaccination serum antibody titers for each of the three vaccine strains will be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluzone® Vaccine Group 1 | Experimental | Participants aged 18 to 59 years at enrollment - Fluzone® Group |
|
| Fluzone® Vaccine Group 2 | Experimental | Participants aged 60 years and older at enrollment - Fluzone® Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza virus vaccine | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Solicited injection site reactions: Erythema, bruising, induration, and Pain at injection site. Solicited systemic reaction: Fever (temperature), chills, rash, headache, cough, runny nose, nausea, vomiting, diarrhea, malaise, myalgia, and arthralgia | Days 0 to 3 Post-vaccination |
| Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone® | Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay. | Day 0 and Day 21 Post-vaccination |
| Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® | Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay. | Day 21 Post-vaccination |
| Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone® | Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay | 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 121 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants were enrolled and treated from 25 July 2003 to 26 August 2003 at 1 US site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluzone® Vaccine Group 1 | Participants were 18 to 59 years old at enrollment in the study |
| FG001 | Fluzone® Vaccine Group 2 | Participants were 60 years or older at enrollment in the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluzone® Vaccine Group 1 | Participants were 18 to 59 years old at enrollment in the study |
| BG001 | Fluzone® Vaccine Group 2 | Participants were 60 years or older at enrollment in the study |
| 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 | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Solicited injection site reactions: Erythema, bruising, induration, and Pain at injection site. Solicited systemic reaction: Fever (temperature), chills, rash, headache, cough, runny nose, nausea, vomiting, diarrhea, malaise, myalgia, and arthralgia | Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population. | Posted | Number | Percentage of Participants | Days 0 to 3 Post-vaccination |
|
6 months
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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 1 | Participants were 18 to 59 years old at enrollment in the study |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 6.0 | Non-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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| Influenza virus vaccine | Biological | 0.5 mL, Intramuscular |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants were 60 years or older at enrollment in the study
|
|
| Primary | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone® | Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay. | The Geometric mean titers were analyzed in the per-protocol immunogenicity population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 and Day 21 Post-vaccination |
|
|
|
| Primary | Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® | Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay. | The vaccine antibody fold rise analysis was in the per-protocol immunogenicity population. | Posted | Number | Percentage of Participants | Day 21 Post-vaccination |
|
|
|
| Primary | Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone® | Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay | The Fluzone® antibody titers were analyzed in the per-protocol immunogenicity population. | Posted | Number | Percentage of Participants | Day 21 Post-vaccination |
|
|
|
| 0 |
| 61 |
| 8 |
| 61 |
| EG001 | Fluzone® Vaccine Group 2 | Participants were 60 years or older at enrollment in the study | 0 | 60 | 2 | 60 |
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 |
| A/New Caledonia/20/99 Pre-Dose |
|
| A/New Caledonia/20/99 Post-Dose |
|
| B/Hong Kong/1434/2002 Pre-Dose |
|
| B/Hong Kong/1434/2002 Post-Dose |
|
| B/Hong Kong/1434/2002 |
|
| B/Hong Kong/1434/2002 |
|