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To compare the groups with respect to influenza immune responses following Dose 1 of Fluzone vaccine (2006-2007 formulation).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluzone®-Primed Group | Experimental | Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28, NCT00242424), will receive 2 doses of Fluzone® Pediatric 2006-2007 formulation. |
|
| Fluzone®-Naive Group | Experimental | Participants had never received Influenza vaccine and had received two doses of placebo in the fall of 2005 (Study GRC28, NCT00242424), will receive 2 doses of Fluzone® Pediatric 2006-2007 formulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Virus Vaccine, Fluzone® | Biological | 0.25 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Seroprotected Participants Post-vaccination With Fluzone® | Seroprotection was defined as a Post-vaccination Hemagglutination Inhibition titer of greater than or equal to 1:40. | Day 28 Post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone® | Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method. | Day 28 Post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Solicited injection site: tenderness, erythema, and swelling; Solicited systemic reactions: fever, vomiting, abnormal crying, drowsiness, appetite loss, and irritability, after each vaccination | Days 0-7 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 |
|---|---|---|---|---|---|---|
| Layton | Utah | 84041 | United States | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 173 participants were enrolled, vaccinated, and analyzed.
Participants were enrolled into this study from 03 October 2006 to 04 January 2007 at 5 US clinical centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluzone®-Primed Group | Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation. |
| FG001 | Fluzone®-Naive Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Influenza Virus Vaccine, Fluzone® | Biological | 0.25 mL, Intramuscular |
|
|
| Pleasant Grove |
| Utah |
| 84062 |
| United States |
| Provo | Utah | 84604 | United States |
| Salt Lake City | Utah | 84107 | United States |
| South Jordan | Utah | 84095 | United States |
Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluzone®-Primed Group | Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation. |
| BG001 | Fluzone®-Naive Group | Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation. |
| 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 | Months |
| |||||||||||||||||
| 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 Seroprotected Participants Post-vaccination With Fluzone® | Seroprotection was defined as a Post-vaccination Hemagglutination Inhibition titer of greater than or equal to 1:40. | Hemagglutination inhibition titers to the Fluzone® vaccine antigens were assessed in the per-protocol immunogenicity population. | Posted | Number | Percentage of Participants | Day 28 Post-vaccination |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone® | Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method. | The Geometric Mean Titers were analyzed in the per-protocol immunogenicity population | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 28 Post-vaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Solicited injection site: tenderness, erythema, and swelling; Solicited systemic reactions: fever, vomiting, abnormal crying, drowsiness, appetite loss, and irritability, after each vaccination | The safety analysis was on all enrolled and vaccinated participants, intent-to-treat population. | Posted | Number | Percentage of Participants | Days 0-7 Post-vaccination |
|
|
Adverse event data were collected for 2 months 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®-Primed Group | Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation. | 1 | 116 | 87 | 116 | ||
| EG001 | Fluzone®-Naive Group | Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation. | 0 | 57 | 40 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Teething | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Croup infectious | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| 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 |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
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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 |
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| Flu B/Malaysia/2506/2004 Post-Dose 1 |
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| Flu A/New Caledonia/20/99 (H1N1) Post-Dose 2 |
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| Flu A/Wisconsin/67/2005 (H3N2) Post -Dose 2 |
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| Flu B/Malaysia/2506/2004 Post-Dose 2 |
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