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To provide Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2007-2008 formulation of the inactivated, split-virion influenza vaccine FluzoneĀ® for further study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza vaccine Naive/Inadequately Primed | Experimental | Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of FluzoneĀ®, on Days 0 and 14. |
|
| Influenza Vaccine Primed | Experimental | Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of FluzoneĀ® on Day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2007-2008 Influenza Virus Vaccine | Biological | 0.25 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Solicited injection site reactions: Erythema, swelling, pain/tenderness; Solicited systemic reactions: (for infants/toddlers) - fever, irritability, abnormal crying, drowsiness, lost appetite, vomiting; (for children) - fever, headache, malaise, myalgia) Note: Influenza-primed group received only dose 1. | Days 0-3 post-dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-FluzoneĀ® Vaccination | Day 0 and Day 14 after last dose of Fluzone | |
| Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection) |
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 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 34 participants who met the inclusion and exclusion criteria were enrolled, 2 were not vaccinated and excluded from the analysis.
The study participants were enrolled from 29 October 2007 through 27 November 2007 at 1 US site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Influenza Vaccine Naive/Inadequately Primed | Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of FluzoneĀ®, on Days 0 and 14. |
| FG001 | Influenza Vaccine Primed | Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of FluzoneĀ® on Day 0. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Influenza Vaccine Naive/Inadequately Primed | Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of FluzoneĀ®, on Days 0 and 14. |
| BG001 | Influenza Vaccine Primed |
| 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 Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Solicited injection site reactions: Erythema, swelling, pain/tenderness; Solicited systemic reactions: (for infants/toddlers) - fever, irritability, abnormal crying, drowsiness, lost appetite, vomiting; (for children) - fever, headache, malaise, myalgia) Note: Influenza-primed group received only dose 1. | Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population. | Posted | Number | Participants | Days 0-3 post-dose |
|
Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza Vaccine Primed group) or 42 days post-vaccination (Influenza Vaccine NaĆÆve/Inadequately Primed group)
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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 | Influenza Vaccine Naive/Inadequately Primed | Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of FluzoneĀ®, on Days 0 and 14. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site tenderness | 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 |
| D009976 | Orthomyxoviridae Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus 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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| 2007-2008 Influenza Virus Vaccine | Biological | 0.25 mL, Intramuscular |
|
|
Seroprotection was defined as a serum hemagglutination inhibition antibody titer ā„40.
| Day 14 post-vaccination |
| Seroconversion Rates for Each Influenza Antigen Post-Vaccination | Seroconversion was defined as a post-vaccination titer ā„ 40 for participants with a titer < 10 on Day 0 and a ā„4-fold increase for participants with a titer ā„ 10 on Day 0. | Day 14 post-vaccination |
Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of FluzoneĀ® on Day 0.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Influenza Vaccine Primed |
Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of FluzoneĀ® on Day 0. |
|
|
| Other Pre-specified | Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-FluzoneĀ® Vaccination | The Geometric Mean Titers analysis were on the per-protocol immunogenicity population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 and Day 14 after last dose of Fluzone |
|
|
|
| Other Pre-specified | Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection) | Seroprotection was defined as a serum hemagglutination inhibition antibody titer ā„40. | The serum hemagglutination inhibition antibody analysis were on the per-protocol immunogenicity population. | Posted | Number | Percentage of Participants | Day 14 post-vaccination |
|
|
|
| Other Pre-specified | Seroconversion Rates for Each Influenza Antigen Post-Vaccination | Seroconversion was defined as a post-vaccination titer ā„ 40 for participants with a titer < 10 on Day 0 and a ā„4-fold increase for participants with a titer ā„ 10 on Day 0. | The seroconversion analysis were on the per-protocol immunogenicity population. | Posted | Number | Percentage of Participants | Day 14 post-vaccination |
|
|
|
| 0 |
| 23 |
| 12 |
| 23 |
| EG001 | Influenza Vaccine Primed | Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of FluzoneĀ® on Day 0. | 0 | 9 | 3 | 9 |
| Injection site pain | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Injection site redness | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Crying | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| Malaise | General 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
| D012140 |
| Respiratory Tract Diseases |
| A/Wisconsin/67/2005 (X-161B) (H3N2) Pre-dose |
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| Wisconsin/67/2005 (X161B) (H3N2) Post-dose |
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| B/Malaysia Split/2506/2004 Pre-dose |
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| B/Malaysia Split/2506/2004 Post-dose |
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| B/Malaysia Split/2506/2004 |
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| B/Malaysia Split/2506/2004 |
|