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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1127-7587 | Other Identifier | WHO |
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The aim of the study is describe the safety and immunogenicity of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to < 65 years of age, and to describe the safety and immunogenicity of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age.
Primary Objective:
Observational objectives:
Participants 18 to < 65 years of age on enrollment will be randomized to receive either Fluzone Quadrivalent or Fluzone Intradermal vaccine. Participants ≥ 65 years of age at enrollment will be randomized to receive either Fluzone Quadrivalent or Fluzone High-Dose vaccine.
Solicited adverse event (AE) information will be collected for 7 days after each vaccination, unsolicited AE and Serious adverse event information will be collected from Visit 1 to Visit 2. Total duration of participation in the study is approximately 21 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Experimental | Participants age 18 to < 65 years randomized to receive a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation) |
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| Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Experimental | Participants age 18 to < 65 years randomized to receive a dose of Fluzone® Intradermal, Influenza Virus Vaccine (2013-2014 formulation) |
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| Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Experimental | Participants age ≥ 65 years randomized to receive a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation) |
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| Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Experimental | Participants age ≥ 65 years randomized to receive a dose of Fluzone® High-Dose, Influenza Virus Vaccine (2013-2014 formulation) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation), | Biological | 0.5 mL, Intramuscular |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm; Fever, ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity. | Day 0 up to Day 21 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | Influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay. | Day 0 (pre-vaccination) and Day 21 after 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 |
|---|---|---|---|---|---|---|
| Santa Rosa | California | 95405 | United States | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 208 participants who met all of the inclusion and none of the exclusion criteria were enrolled and vaccinated in the study.
The study participants were enrolled from 16 to 24 September 2013 at 4 clinic centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Participants age 18 to < 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation) |
| FG001 | Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Fluzone® Intradermal, Influenza Virus Vaccine (2013-2014 formulation), | Biological | 0.1 mL, Intradermal |
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| Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation), | Biological | 0.5 mL, Intramuscular |
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| Fluzone® High-Dose, Influenza Virus Vaccine (2013-2014 formulation) | Biological | 0.5 mL, Intramuscular |
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| Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | Influenza virus antibodies were measured using an HAI assay. Seroprotection was defined as a titer of ≥40 (1/dilution). | Day 0 (pre-vaccination) and Day 21 after vaccination |
| Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | Influenza virus antibodies were measured using an HAI assay. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in titer after vaccination. | Day 0 (pre-vaccination) and Day 21 after vaccination |
| Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine | Influenza virus antibodies were measured using an HAI assay. Geometric mean titer ratios are the geometric means of the individual post-vaccination/pre-vaccination titer ratios for each hemagglutinin antigen contained in the vaccines. | Day 21 after vaccination |
| Council Bluffs |
| Iowa |
| 51503 |
| United States |
| Metairie | Louisiana | 70006 | United States |
| Cincinnati | Ohio | 45249 | United States |
Participants age 18 to < 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation) |
| FG002 | Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation) |
| FG003 | Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Participants age 18 to < 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation) |
| BG001 | Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Participants age 18 to < 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation) |
| BG002 | Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation) |
| BG003 | Elderly Fluzone® High Dose, Influenza Vaccine (Group 4) | Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation) |
| 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 | |||||||||||||||||||||||||||||
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| Primary | Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. | Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm; Fever, ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity. | Solicited injection-site reactions and systemic reactions were assessed using the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine. | Number | Participants | Day 0 up to Day 21 post-vaccination |
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| Secondary | Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine | Influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay. | Geometric mean titers of antibodies against the hemagglutinin (HA) antigens were assessed in the Per-Protocol Analysis Set. | Geometric Mean | 95% Confidence Interval | Titers | Day 0 (pre-vaccination) and Day 21 after vaccination |
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| Secondary | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | Influenza virus antibodies were measured using an HAI assay. Seroprotection was defined as a titer of ≥40 (1/dilution). | Seroprotection against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set. | Number | Participants | Day 0 (pre-vaccination) and Day 21 after vaccination |
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| Secondary | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine | Influenza virus antibodies were measured using an HAI assay. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in titer after vaccination. | Seroconversion against the hemagglutinin antigens contained in the vaccine were assessed in the Per-Protocol Analysis Set. | Number | Participants | Day 0 (pre-vaccination) and Day 21 after vaccination |
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| Secondary | Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine | Influenza virus antibodies were measured using an HAI assay. Geometric mean titer ratios are the geometric means of the individual post-vaccination/pre-vaccination titer ratios for each hemagglutinin antigen contained in the vaccines. | Geometric mean titer ratios against each hemagglutinin antigen were assessed in the Per-Protocol Analysis Set. | Geometric Mean | 95% Confidence Interval | Titer Ratio | Day 21 after vaccination |
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Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after 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 | Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) | Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation) | 1 | 52 | 27 | 52 | ||
| EG001 | Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) | Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation) | 0 | 52 | 30 | 52 | ||
| EG002 | Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) | Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation) | 1 | 52 | 10 | 52 | ||
| EG003 | Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation) | 0 | 52 | 21 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device failure | General disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Altered state of consciousness | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection-site pain | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Injection-site erythema | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Injection-site induration | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Shivering | General disorders | MedDRA 16.0 | 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 (N = 52, 52, 52, 52) |
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| Injection-ste erythema (N=52,52,52,51) |
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| Grade 3 Injection-site erythema (N =52, 52,52, 51) |
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| Injection-site swelling (N = 51, 52, 52, 51) |
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| Grade 3 Injection-site swelling (N = 51,52,52,51) |
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| Injection-site induration (N = 51, 52, 52, 51) |
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| Grade 3 Injection-site induration (N= 51,52,52,51) |
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| Injection-site ecchymosis (N = 51, 52, 52, 51) |
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| Grade 3 Injection-site ecchymosis (N= 51,52,52,51) |
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| Fever (N = 52, 52, 52, 52) |
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| Grade 3 Fever (N = 52, 52, 52, 52) |
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| Headache (N = 52, 52, 52, 51) |
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| Grade 3 Headache (N = 52, 52, 52, 51) |
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| Malaise (N = 52, 52, 52, 52) |
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| Grade 3 Malaise (N = 52, 52, 52, 52) |
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| Myalgia (N = 52, 52, 52, 51) |
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| Grade 3 Myalgia (N = 52, 52, 52, 51) |
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| Shivering (N = 52, 52, 52, 51) |
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| Grade 3 Shivering (N = 52, 52, 52, 51) |
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| OG003 | Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation) |
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| OG003 |
| Elderly Fluzone® High Dose, Influenza Vaccine (Group 4) |
Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation) |
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| OG003 | Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation) |
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| OG003 | Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4) | Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation) |
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