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The study is to compare the 2 Groups with respect to antibody responses to inactivated influenza vaccine.
Observational Objectives:
This is a descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children who were given Fluzone® vaccine at 2 months of age (Study GRC27 NCT00858468)and those who never received influenza vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluzone® Vaccine-Primed Group | Experimental | Participants received 2 doses of Fluzone® vaccine at 2 months (in Study GRC 27) |
|
| Influenza Vaccine-Naive Group | Active Comparator | Participants who have never received influenza vaccine (and not in Study GRC27) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Virus Vaccine | Biological | 0.25 mL, Intramuscular |
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| Measure | Description | Time Frame |
|---|---|---|
| Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine. | Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine. | Day 28 Post-vaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine. | Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method. | Day 28 Post-vaccination |
| Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | 72205 | United States | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 242 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants were enrolled from 17 October 2005 to 05 January 2006 at 7 medical centers in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluzone® Vaccine-Primed Group | Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months. |
| FG001 | Influenza Vaccine-Naive Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Influenza Virus Vaccine | Biological | 0.25 mL, Intramuscular |
|
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Antibodies against Pertussis, Tetanus, and Haemophilus influenzae antigens were determined by an indirect Enzyme linked immunosorbent assay (ELISA). Anti-diphtheria antibody response was measured by the Vero Cells - diphtheria toxin challenge method. The serological determinations of total anti-PRP antibody was performed using a Farr-type radioimmunoassay. |
| Day 28 Post-vaccination |
| Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Human antibodies to Streptococcus pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were determined by an Enzyme linked immunosorbent assay (ELISA). | Day 28 post-vaccination |
| Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Antibodies to polio viruses were measured by a serum neutralization assay. | Day 28 post-vaccination |
| Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Solicited injection site reactions: Tenderness, erythema and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability. | Days 0 up to 7 post-vaccination |
| Marietta |
| Georgia |
| 30062 |
| United States |
| Durham | North Carolina | 27704 | United States |
| Dayton | Ohio | 45404 | United States |
| Pittsburgh | Pennsylvania | 15241 | United States |
| Seattle | Washington | 98040 | United States |
Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluzone® Vaccine-Primed Group | Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months. |
| BG001 | Influenza Vaccine-Naive Group | Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| 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 | Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine. | Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine. | Hemagglutination inhibition titers to the Influenza vaccine antigens were assessed in the per-protocol immunogenicity population. | Posted | Number | Percentage of Participants | Day 28 Post-vaccination |
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| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine. | Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method. | Geometric Mean Titers to the Influenza vaccine antigens were assessed in the per-protocol immunogenicity population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 28 Post-vaccination |
|
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| Other Pre-specified | Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine. | Antibodies against Pertussis, Tetanus, and Haemophilus influenzae antigens were determined by an indirect Enzyme linked immunosorbent assay (ELISA). Anti-diphtheria antibody response was measured by the Vero Cells - diphtheria toxin challenge method. The serological determinations of total anti-PRP antibody was performed using a Farr-type radioimmunoassay. | GMTs to the Pertussis, Tetanus, Diphtheria and Haemophilus Influenzae antigens were assessed in the per-protocol immunogenicity population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 28 Post-vaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Human antibodies to Streptococcus pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were determined by an Enzyme linked immunosorbent assay (ELISA). | Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal antibodies were determined in the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 28 post-vaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Antibodies to polio viruses were measured by a serum neutralization assay. | Geometric Mean Titers (GMTs) for the Polio antibodies were determined in the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 28 post-vaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Solicited injection site reactions: Tenderness, erythema and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability. | Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population | Posted | Number | Percentage of Participants | Days 0 up to 7 post-vaccination |
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Adverse event data were collected over a period of 8 months. Six months post-vaccination 2
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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-Primed Group | Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months. | 5 | 112 | 57 | 112 | ||
| EG001 | Influenza Vaccine-Naive Group | Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months. | 1 | 130 | 56 | 130 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sickle cell anaemia with crisis | Congenital, familial and genetic disorders | MedDRA 7.1 | Non-systematic Assessment |
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| Deafness bilateral | Ear and labyrinth disorders | MedDRA 7.1 | Non-systematic Assessment |
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| Bronchiolitis | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
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| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 7.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 7.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 7.1 | Non-systematic Assessment |
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| Bronchiolitis | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
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| Croup infectious | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | 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 |
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| Male |
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| B/Jiangsu/310/2003 Post-Dose 1 |
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| A/New Caledonia/20/99 Post-Dose 2 |
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| A/New York/55/2004 Post-Dose 2 |
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| B/Jiangsu/310/2003 Post-Dose 2 |
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| Participants |
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