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To provide Centers for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2006-2007 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC) and World Health Organization (WHO).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza vaccine-naive group | Experimental | Participants have never received Influenza virus vaccine in the past. They will receive a single dose of Fluzone vaccine on Day 0 and Day 28, respectively. |
|
| Influenza vaccine-primed group | Experimental | Participants have received Influenza virus vaccine in the past. They will receive a single dose of Fluzone vaccine on Day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Virus Vaccine (Fluzone®) | Biological | 0.25 mL, Intramuscular (infant/children dose) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination | GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone vaccine 2006-2007 Pediatric formulation. Post-dose 1 (Influenza vaccine-primed group); Post-dose 2 (Influenza vaccine-naive group) | 14 days post-vaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia). |
Inclusion Criteria:
Exclusion Criteria:
Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
An acute illness with or without fever (For infants/toddlers: temperature
≥ 100.4 °F rectal; For children: temperature ≥ 99.5 °F oral/axillary) in the 72 hours preceding enrollment in the trial (Enrollment may be deferred).
Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude).
Participation in any other interventional clinical trial within 30 days prior to enrollment up to termination of the subject's participation in the study.
Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth.
Personal or immediate family history of congenital immune deficiency.
Developmental delay, neurologic disorder, or seizure disorder.
Chronic medical, congenital, or developmental disorder.
Known human immunodeficiency virus (HIV)-positive mother.
Prior personal history of Guillain-Barré syndrome.
Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norfolk | Virginia | 23510 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 31 subjects that met the inclusion and exclusion criteria were enrolled and vaccinated.
Subjects were recruited from 13 October to 13 December 2006, at a single site in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Influenza Vaccine-Naive Group | Participants have never received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively. |
| FG001 | Influenza Vaccine-Primed Group | Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Influenza Vaccine-Naive Group | Participants have never received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively. |
| BG001 | Influenza Vaccine-Primed Group |
| 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 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination | GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone vaccine 2006-2007 Pediatric formulation. Post-dose 1 (Influenza vaccine-primed group); Post-dose 2 (Influenza vaccine-naive group) | Geometric mean titers were evaluated in the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 14 days post-vaccination |
|
Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
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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 Group | Participants have never received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively. |
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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 |
| 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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| Influenza Virus Vaccine (Fluzone®) | Biological | 0.25 mL, Intramuscular (infant/children dose) |
|
|
| 0 to 3 days post-vaccination 1 |
| Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia). Note: Influenza vaccine-primed group did not receive vaccination 2 | 0 to 3 days post-vaccination 2 |
Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine 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 |
|
Subjects have received Influenza virus vaccine in the past
|
|
| Other Pre-specified | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia). | Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population | Posted | Number | Participants | 0 to 3 days post-vaccination 1 |
|
|
|
| Other Pre-specified | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia). Note: Influenza vaccine-primed group did not receive vaccination 2 | Safety analysis was on all enrolled and vaccinated participants, intend to treat population. Influenza vaccine-primed group did not received vaccination 2 | Posted | Number | Participants | 0 to 3 days post-vaccination 2 |
|
|
|
| 0 |
| 14 |
| 9 |
| 14 |
| EG001 | Influenza Vaccine-Primed Group | Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0. | 0 | 17 | 7 | 17 |
| 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 |
|
| Vomiting NOS | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| 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 |
|
| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Teething | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Irritability | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| 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 |
|
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 |
| Grade 3 injection site Tenderness-reduced movement |
|
| Any injection site Pain |
|
| Grade 3 injection site Pain (Incapacitating) |
|
| Any injection site Redness |
|
| Grade 3 injection site Redness (≥ 5.0 cm) |
|
| Any injection site Swelling |
|
| Grade 3 injection site Swelling (≥ 5.0 cm) |
|
| Any Solicited Systemic Reaction Post-dose 1 |
|
| Any Fever |
|
| Grade 3 Fever (>103.1°F) |
|
| Any Vomiting (Per 24 hours) |
|
| Grade 3 Vomiting (≥ 6 episodes) |
|
| Any Abnormal Crying |
|
| Grade 3 Abnormal Crying (> 3 hours) |
|
| Any Drowsiness |
|
| Grade 3 Drowsiness (Sleeping most time) |
|
| Any Loss of Appetite |
|
| Grade 3 Loss of Appetite (Refuses ≥ 3 feeds) |
|
| Any Irritability |
|
| Grade 3 Irritability (Inconsolable) |
|
| Any Headache |
|
| Grade 3 Headache (Prevented daily activities) |
|
| Any Myalgia |
|
| Grade 3 Myalgia (Prevented daily activities) |
|
| Any Malaise |
|
| Grade 3 Malaise (Prevented daily activities) |
|
| Title | Measurements |
|---|---|
|
| Any injection site Pain |
|
| Grade 3 injection site Pain (incapacitating) |
|
| Any injection site Redness |
|
| Grade 3 injection site Redness (≥ 5.0 cm) |
|
| Any injection site Swelling |
|
| Grade 3 injection site Swelling (≥ 5.0 cm) |
|
| Any solicited systemic reaction Post-dose 2 |
|
| Any Fever |
|
| Grade 3 Fever (> 103.1ºF) |
|
| Any Vomiting (per 24 hours) |
|
| Grade 3 Vomiting (≥ 6 episodes) |
|
| Any abnormal Crying |
|
| Grade 3 abnormal Crying (> 3 hours) |
|
| Any Drowsiness |
|
| Grade 3 Drowsiness (sleeping most time) |
|
| Any Loss of appetite |
|
| Grade 3 Loss of appetitie (refuses 3 feeds) |
|
| Any Irritability |
|
| Grade 3 Irritability (inconsolable) |
|
| Any Headache |
|
| Grade 3 Headache (prevents daily activities) |
|
| Any Myalgia |
|
| Grade 3 Myalgia (prevents daily activities) |
|
| Any Malaise |
|
| Grade 3 Malaise (prevents daily activities) |
|