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Primary Objective:
To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Split, Inactivated, Trivalent Influenza Vaccine |
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| 2 | Experimental | Split, Inactivated, Trivalent Influenza Vaccine |
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| 3 | Active Comparator | Split, Inactivated, Trivalent Influenza Vaccine |
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| 4 | Active Comparator | Split, Inactivated, Trivalent Influenza Vaccine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Split, Inactivated, Trivalent Influenza Vaccine | Biological | Vaccine (infant dose) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine | Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique. | Day 0 and Day 28 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine | Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique. | Day 28 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 |
|---|---|---|---|---|---|---|
| Harrisburg | Arkansas | 72432 | United States | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 517 of the 520 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Study participants ere enrolled from 19 October to 12 December 2006 in 20 clinical centers in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Fluzone ID at Age 6 to 35 Months | Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine |
| FG001 | Group 2: Fluzone IM 6 to 35 Months Age Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Split, Inactivated, Trivalent Influenza Vaccine |
| Biological |
Vaccine (children dose) |
|
| Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation) | Biological | Vaccine (infant dose) |
|
|
| Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation) | Biological | Vaccine (children dose) |
|
|
| Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine |
Seroprotection was defined as participants achieving a post-dose antibody titers ≥40. Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique. |
| Day 28 post-vaccination |
| Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine | Seroconversion was defined as the conversion to a post-vaccination titer of ≥ 40 for subjects with pre-vaccination titer < 10, or at least a 4-fold increase in post vaccination titer for subjects with pre vaccination titer ≥ 10. | Day 28 post-vaccination |
| Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months. | Solicited injection site reactions: Tenderness, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability. | Day 0 to Day 7 post-vaccination |
| Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds | Solicited injection site reactions: Pain, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia. | Day 0 to Day 7 post-vaccination |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Trumann | Arkansas | 72472 | United States |
| Bellflower | California | 90706 | United States |
| Downey | California | 90241 | United States |
| Fountain Valley | California | 92708 | United States |
| Paramount | California | 90723 | United States |
| Owensboro | Kentucky | 42303 | United States |
| Bossier City | Louisiana | 71111 | United States |
| Shreveport | Louisiana | 71105 | United States |
| Brainerd | Minnesota | 56401 | United States |
| Cleveland | Ohio | 44121 | United States |
| Erie | Pennsylvania | 16505 | United States |
| Pittsburgh | Pennsylvania | 15277 | United States |
| Uniontown | Pennsylvania | 15401 | United States |
| Wexford | Pennsylvania | 15090 | United States |
| Fort Worth | Texas | 76107 | United States |
| Salt Lake City | Utah | 84109 | United States |
| Salt Lake City | Utah | 84121 | United States |
Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
| FG002 | Group 3: Fluzone ID at 3 to 8 Years Age | Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine |
| FG003 | Group 4: Fluzone IM 3 to 8 Years Age | Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Fluzone ID at Age 6 to 35 Months | Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine |
| BG001 | Group 2: Fluzone IM 6 to 35 Months Age Group | Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine |
| BG002 | Group 3: Fluzone ID at 3 to 8 Years Age | Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine |
| BG003 | Group 4: Fluzone IM 3 to 8 Years Age | Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine |
| BG004 | 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 | Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine | Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique. | Geometric Mean Titers were determined in the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 and Day 28 post-vaccination |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine | Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique. | 4-Fold Rise in Serum HAI Antibody Titers were determined in the per-protocol population | Posted | Number | Percentage of Participants | Day 28 post-vaccination |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine | Seroprotection was defined as participants achieving a post-dose antibody titers ≥40. Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique. | Seroprotection to vaccine antigens were determined in the per-protocol population | Posted | Number | Percentage of Participants | Day 28 post-vaccination |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine | Seroconversion was defined as the conversion to a post-vaccination titer of ≥ 40 for subjects with pre-vaccination titer < 10, or at least a 4-fold increase in post vaccination titer for subjects with pre vaccination titer ≥ 10. | Seroconversion to vaccine antigens were determined in the per-protocol population | Posted | Number | Percentage of Participants | Day 28 post-vaccination |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months. | Solicited injection site reactions: Tenderness, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability. | Safety parameters were determined post-vaccination in the safety, intend-to-treat population. | Posted | Number | Participants | Day 0 to Day 7 post-vaccination |
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| Secondary | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds | Solicited injection site reactions: Pain, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia. | Safety parameters were determined post-vaccination in the safety, intend-to-treat population. | Posted | Number | Participants | Day 0 to Day 7 post-vaccination |
|
Adverse events data were collected from the day of vaccination to up to 6 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 | Group 1: Fluzone ID at Age 6 to 35 Months | Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine | 1 | 97 | 51 | 97 | ||
| EG001 | Group 2: Fluzone IM 6 to 35 Months Age Group | Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine | 1 | 97 | 49 | 97 | ||
| EG002 | Group 3: Fluzone ID at 3 to 8 Years Age | Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine | 1 | 160 | 98 | 160 | ||
| EG003 | Group 4: Fluzone IM 3 to 8 Years Age | Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine | 1 | 163 | 90 | 163 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis viral | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Autism | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| 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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| Vessel puncture site bruise | General disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Croup infections | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Gastroenteritis | 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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| Sinusitis | 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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| Viral 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 |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Injection site Tenderness | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Injection site Redness | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Injection site Swelling | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Injection site Induration | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Injection site Ecchymosis | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Crying abnormal | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
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| Drowsiness | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Appetite lost | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Irritability | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Myalgia | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 9.0 | 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 |
|---|---|
| D009976 | Orthomyxoviridae Infections |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| 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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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Serogroup A/H1N1 Post-vaccination 1 |
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| Serogroup A/H1N1 Post-vaccination 2 |
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| Serogroup A/H3N2 Pre-vaccination |
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| Serogroup A/H3N2 Post-vaccination 1 |
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| Serogroup A/H3N2 Post-vaccination 2 |
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| Serogroup B Pre-vaccination |
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| Serogroup B Post-vaccination 1 |
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| Serogroup B Post-vaccination 2 |
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Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine |
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Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
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Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine |
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Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
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