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| ID | Type | Description | Link |
|---|---|---|---|
| U 1111-1124-8310 | Other Identifier | WHO |
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The aim of this study is to evaluate the safety and immunogenicity of Fluzone vaccine (18 years to <65 years of age and ≥ 65 years of age), Fluzone Intradermal vaccine (18 years to <65 years of age), and Fluzone High-Dose vaccine (≥ 65 years of age).
Primary Objective:
Observational Objectives:
Participants 18 to < 65 years of age will be randomized to receive a dose of either Fluzone or Fluzone Intradermal vaccine and participants ≥ 65 years of age will be randomized to receive a dose of Fluzone or Fluzone High-Dose vaccine. All participants will be followed up for safety and immunogenicity. The duration of participation in the trial will be approximately 21 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluzone vaccine (Group 1) | Experimental | Adults 18 to < 65 years of age randomized to receive one dose of Fluzone vaccine intramuscularly |
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| Fluzone Intradermal vaccine (Group 2) | Experimental | Adults 18 to < 65 years of age randomized to receive one dose of Fluzone Intradermal vaccine intradermally |
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| Fluzone vaccine (Group 3) | Experimental | Adults ≥ 65 years of age randomized to receive one dose of Fluzone vaccine intramuscularly |
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| Fluzone High-Dose Vaccine (Group 4) | Active Comparator | Adults ≥ 65 years of age randomized to receive one dose of Fluzone High-Dose vaccine intramuscularly |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Solicited injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain - Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - >100 mm. Grade 3 systemic reactions: Fever ≥39.0°C; Headache, Malaise, Myalgia, and Shivering - significant, prevents daily activity. | Day 0 up to Day 7 post-vaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. | Day 0 (pre-vaccination) up to Day 21 post-vaccination |
| Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine |
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 |
|---|---|---|---|---|---|---|
| Boca Raton | Florida | 33432 | United States | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 200 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.
The study participants were enrolled from 19 through 27 September 2012 at 4 clinic centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluzone® Vaccine (Group 1) | Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly |
| FG001 | Fluzone® Intradermal Vaccine (Group 2) | Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Influenza Virus Vaccine: Fluzone® Intradermal 2012-2013 Formulation | Biological | 0.1 mL, Intradermal |
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| Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation | Biological | 0.5 mL, Intramuscular |
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| Influenza Virus Vaccine: Fluzone® High-Dose 2012-2013 Formulation | Biological | 0.5 mL, Intramuscular |
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Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroprotection was defined as a pre-vaccination or a post-vaccination titer ≥ 40 (l/dil). |
| Day 0 (pre-vaccination) and Day 21 post-vaccination |
| Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer. | Day 0 (pre-vaccination) and Day 21 post-vaccination |
| Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay to determine pre-vaccination and post-vaccination titers of <1:10. | Day 0 (pre-vaccination) and Day 21 post-vaccination |
| South Miami |
| Florida |
| 33143 |
| United States |
| Council Bluffs | Iowa | 51503 | United States |
| Metairie | Louisiana | 70006 | United States |
| FG002 | Fluzone® Vaccine (Group 3) | Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly |
| FG003 | Fluzone® High-Dose Vaccine (Group 4) | Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluzone® Vaccine (Group 1) | Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly |
| BG001 | Fluzone® Intradermal Vaccine (Group 2) | Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally |
| BG002 | Fluzone® Vaccine (Group 3) | Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly |
| BG003 | Fluzone® High-Dose Vaccine (Group 4) | Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly |
| 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 |
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| Age Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Solicited injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain - Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - >100 mm. Grade 3 systemic reactions: Fever ≥39.0°C; Headache, Malaise, Myalgia, and Shivering - significant, prevents daily activity. | Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set. | Posted | Number | Participants | Day 0 up to Day 7 post-vaccination |
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| Other Pre-specified | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. | Geometric mean titers against the influenza virus antigens were assessed in the Per-Protocol Analysis Set. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 (pre-vaccination) up to Day 21 post-vaccination |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroprotection was defined as a pre-vaccination or a post-vaccination titer ≥ 40 (l/dil). | Seroprotection against influenza vaccine antigens were assessed in the Per-Protocol Analysis Set. | Posted | Number | Participants | Day 0 (pre-vaccination) and Day 21 post-vaccination |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer. | Seroconversion to the influenza virus vaccine antigens was assessed in the Per-Protocol Analysis Set. | Posted | Number | Participants | Day 0 (pre-vaccination) and Day 21 post-vaccination |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay to determine pre-vaccination and post-vaccination titers of <1:10. | Antibody responses to the influenza vaccine antigens were assessed in the Per-Protocol Analysis Set. | Posted | Number | Participants | Day 0 (pre-vaccination) and Day 21 post-vaccination |
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Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 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 Vaccine (Group 1) | 'Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly' | 0 | 50 | 12 | 50 | ||
| EG001 | Fluzone Intradermal Vaccine (Group 2) | Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally | 0 | 50 | 20 | 50 | ||
| EG002 | Fluzone Vaccine (Group 3) | Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly | 2 | 51 | 13 | 51 | ||
| EG003 | Fluzone High-Dose Vaccine (Group 4) | Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly | 0 | 49 | 19 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site Pain | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Injection site Erythema | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Injection site Swelling | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Injection site Induration | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Headache | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Shivering | General disorders | MedDRA 15.0 | 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 |
|---|---|
| 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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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Grade 3 Injection site Pain |
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| Injection site Erythema |
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| Grade 3 Injection site Erythema |
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| Injection site Swelling |
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| Grade 3 Injection site Swelling |
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| Injection site Induration |
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| Grade 3Injection site Induration |
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| Injection site Ecchymosis |
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| Grade 3 Injection site Ecchymosis |
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| Fever |
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| Grade 3 Fever |
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| Headache |
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| Grade 3 Headache |
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| Malaise |
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| Grade 3 Malaise |
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| Myalgia |
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| Grade 3 Myalgia |
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| Shivering |
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| Grade 3 Shivering |
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Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
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| Fluzone® High-Dose Vaccine (Group 4) |
Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly |
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Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
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