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To describe the safety during Days 0 to 21 following injection of the 2005-2006 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 (antibodies to hemagglutinin) 21 days following injection of the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone, in subjects aged 18-59 years and subjects aged ≥ 60 years.
To submit remaining available sera to the Center for Biologics Evaluation and Research (CBER) for further analysis by the Food and Drug Administration (FDA), 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 |
|---|---|---|---|
| Age 18 to 59 years | Experimental | Participants aged 18 to 59 years at enrollment. |
|
| Age 60 years and older | Experimental | Participants aged 60 years and older at enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzone®: Influenza Virus Vaccine | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination | Day 0 to 3 post-vaccination | |
| Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Before and After Fluzone® Vaccination | GMTs and their 95% Confidence Intervals are presented for each of the 3 antigens in Fluzone® vaccine (2005-2006 Formulation) | 21 days post-vaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With ≥ 40 Serum Hemagglutination Inhibition Antibody Titers Post-vaccination. | Seroprotection: Percentage of participants with ≥ 40 serum hemagglutination inhibition antibody titers 21 days post-vaccination. | 21 Days post-vaccination |
| Percentage of Participants With a ≥ 4-fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-vaccination |
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 subjects that met the inclusion and exclusion criteria were enrolled and vaccinated.
Study participants were enrolled from 09 September to 18 October 2005 in one medical clinic in the US
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| ID | Title | Description |
|---|---|---|
| FG000 | Age 18 to 59 Years | Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly. |
| FG001 | Age 60 Years and Older | Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Age 18 to 59 Years | Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly. |
| BG001 | Age 60 Years and Older | Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly. |
| 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 | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination | Safety analysis was on all enrolled and vaccinated subjects intent-to-treat safety population with available reaction data. | Posted | Number | Participants | Day 0 to 3 post-vaccination |
|
Adverse events data were collected from the day of vaccination for 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 | Age 18 to 59 Years | Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 7.1 | 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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| Fluzone®: Influenza Virus Vaccine | Biological | 0.5 mL, Intramuscular |
|
|
Seroconversion: percentage of participants with at least a 4-fold increase in serum hemagglutination inhibition antibody titers at 21 days post-vaccination. |
| Day 21 post-vaccination |
| 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Before and After Fluzone® Vaccination | GMTs and their 95% Confidence Intervals are presented for each of the 3 antigens in Fluzone® vaccine (2005-2006 Formulation) | GMT results were assessed on the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 21 days post-vaccination |
|
|
|
| Other Pre-specified | Percentage of Participants With ≥ 40 Serum Hemagglutination Inhibition Antibody Titers Post-vaccination. | Seroprotection: Percentage of participants with ≥ 40 serum hemagglutination inhibition antibody titers 21 days post-vaccination. | Seroprotection was assessed in the per-protocol population | Posted | Number | Percentage of participants | 21 Days post-vaccination |
|
|
|
| Other Pre-specified | Percentage of Participants With a ≥ 4-fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-vaccination | Seroconversion: percentage of participants with at least a 4-fold increase in serum hemagglutination inhibition antibody titers at 21 days post-vaccination. | Seroconversion was assessed in the per-protocol population. | Posted | Number | Percentage of participants | Day 21 post-vaccination |
|
|
|
| 0 |
| 60 |
| 15 |
| 60 |
| EG001 | Age 60 Years and Older | Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly. | 0 | 60 | 5 | 60 |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 7.1 | 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.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| A/New York/55/2004 (H3N2), Pre |
|
| A/New York/55/2004 (H3N2), Post |
|
| B/Jiangsu/10/2003, Pre |
|
| B/Jiangsu/10/2003, Post |
|
| B/Jiangsu/10/2003 ≥ 40 |
|
| B/Jiangsu/10/2003 ≥ 4 fold-rise |
|