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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1143-8931 | Other Identifier | WHO |
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The aim of this trial is to evaluate the safety and immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® Intradermal vaccines in adults 18 to < 65 years or age, and of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® High-Dose vaccines in adults ≥ 65 years of age.
Objectives:
Observational objectives:
Adults 18 to < 65 years of age will be randomly assigned in a 1:1 ratio to receive either Fluzone® Quadrivalent or Fluzone® Intradermal vaccine. Adults ≥ 65 years of age will also be randomly assigned in a 1:1 ratio to receive either Fluzone® Quadrivalent or Fluzone® High-Dose vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluzone® Quadrivalent vaccine Group 1 | Experimental | Adults 18 to < 65 years of age randomly assigned to receive an intramuscular injection of Fluzone® Quadrivalent vaccine |
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| Fluzone® Intradermal vaccine Group 2 | Experimental | Adults 18 to < 65 years of age randomly assigned to receive an intradermal injection of Fluzone® Intradermal vaccine |
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| Fluzone® Quadrivalent vaccine Group 3 | Experimental | Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of Fluzone® Quadrivalent vaccine |
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| Fluzone® High-Dose vaccine Group 4 | Experimental | Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of Fluzone® High-Dose vaccine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzone® Quadrivalent vaccine, 2014-2015 formulation | Biological | 0.5 mL, Intramuscular |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 Injection-site reactions: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm. Grade 3 Systemic reactions: Fever, ≥39.0°C or ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity. | Day 0 up to Day 7 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | Geometric mean titers of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. |
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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 criteria and none of the exclusion criteria were enrolled and vaccinated in this study.
Study participants were enrolled from 01 October 2014 to 07 November 2014 at 4 clinical sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine. |
| FG001 | Group 2 | Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Fluzone I®ntradermal vaccine, 2014-2015 formulation | Biological | 0.1 mL, Intradermal |
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| Fluzone® Quadrivalent vaccine, 2014-2015 formulation | Biological | 0.5 mL, Intramuscular |
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| Fluzone High Dose vaccine, 2014-2015 formulation | Biological | 0.5 mL, Intramuscular |
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| Day 0 (pre-vaccination) and Day 21 post-vaccination |
| Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥40 (l/dilution [dil]) at pre-vaccination and 21 days after vaccination. | Day 0 (pre-vaccination) and Day 21 post-vaccination |
| Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the 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 21 days after vaccination. | Day 21 post-vaccination |
| Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine | Geometric mean titer ratios of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. | Day 21 post-vaccination |
| Council Bluffs |
| Iowa |
| 51503 |
| United States |
| Metairie | Louisiana | 70006 | United States |
| Cincinnati | Ohio | 45249 | United States |
| FG002 | Group 3 | Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine. |
| FG003 | Group 4 | Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine. |
| BG001 | Group 2 | Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine. |
| BG002 | Group 3 | Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine. |
| BG003 | Group 4 | Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose 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 |
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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 | Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 Injection-site reactions: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm. Grade 3 Systemic reactions: Fever, ≥39.0°C or ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity. | Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set. | Posted | Number | Percentage of participants | Day 0 up to Day 7 post-vaccination |
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| Secondary | Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. | Geometric mean titers of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. | Geometric mean titers were assessed in the Per-Protocol Analysis Set. | Posted | Geometric Mean | 95% Confidence Interval | Titers (1/dilution) | Day 0 (pre-vaccination) and Day 21 post-vaccination |
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| Secondary | Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. | Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥40 (l/dilution [dil]) at pre-vaccination and 21 days after vaccination. | Seroprotection was assessed in the Per-Protocol Analysis Set. | Posted | Number | Percentage of participants | Day 0 (pre-vaccination) and Day 21 post-vaccination |
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| Secondary | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine | Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the 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 21 days after vaccination. | Seroconversion was assessed in the Per-Protocol Analysis Set. | Posted | Number | Percentage of participants | Day 21 post-vaccination |
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| Secondary | Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine | Geometric mean titer ratios of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. | Geometric mean titer ratios were assessed in the Per-Protocol Analysis Set. | Posted | Geometric Mean | 95% Confidence Interval | Titer ratios | Day 21 post-vaccination |
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Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 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 | Group 1 | Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine. | 0 | 49 | 26 | 49 | ||
| EG001 | Group 2 | Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine. | 0 | 54 | 28 | 54 | ||
| EG002 | Group 3 | Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine. | 1 | 52 | 19 | 52 | ||
| EG003 | Group 4 | Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine. | 0 | 52 | 21 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematochezia | Gastrointestinal 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 Swelling | 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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| Injection site Ecchymosis | 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 |
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral 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 3 Injection-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 randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine. |
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Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine. |
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| OG003 |
| Group 4 |
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine. |
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Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine. |
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