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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1161-2491 | Other Identifier | WHO |
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The aim of the study is to evaluate the safety and immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults 18 to < 65 years of age, and of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age.
Primary Objective:
- To describe the safety of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults 18 to < 65 years of age and the safety of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age.
Observational Objectives:
Adults age 18 to < 65 years will be randomly assigned to receive either Fluzone Quadrivalent or Fluzone Intradermal Quadrivalent vaccine and adults age ≥ 65 years will be randomly assigned to receive either Fluzone Quadrivalent or Fluzone High-Dose vaccine. All subjects will receive a single dose of their randomly assigned vaccine.
They will be followed from Visit 1 to Visit 2 for evaluation of safety outcomes. Solicited adverse reactions will be collected for 7 days after vaccination. Unsolicited non-serious adverse events (AEs) and serious adverse events (SAEs) will be collected from Visit 1 to Visit 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group 1 | Experimental | Adults 18 to < 65 years of age randomly assigned to receive an intramuscular injection of one dose of Fluzone Quadrivalent vaccine |
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| Study Group 2 | Experimental | Adults 18 to < 65 years of age randomly assigned to receive an intradermal injection of one dose of Fluzone Intradermal Quadrivalent vaccine |
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| Study Group 3 | Experimental | Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of Fluzone Quadrivalent vaccine |
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| Study Group 4 | Experimental | Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of Fluzone High-Dose vaccine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative | Biological | 0.5 mL, Intramuscular (IM) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 solicited injection-site reactions: Pain, Significant; prevents daily activity. Erythema, Swelling, Induration, and Ecchymosis >100 mm. Grade 3 solicited systemic reactions: Fever, ≥ 39.0°C or ≥ 102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity. A participant (18 to < 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was excluded from the Per-protocol analysis Set and was included in the Fluzone Quadrivalent vaccine Group in the Safety Analysis Set and the assigned group in the Full Analysis Set. | Day 0 up to Day 7 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Anti-influenza antibodies were measured using an hemagglutination inhibition assay. | Day 0 (pre-vaccination) and 21 days 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 |
|---|---|---|---|---|---|---|
| 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 no exclusion criteria were enrolled and vaccinated.
Study participants were enrolled from 28 September 2015 to 03 November 2015 at 4 clinic centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine |
| FG001 | Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Fluzone Intradermal Quadrivalent vaccine, 2015-2016 formulation | Biological | 0.1 mL, Intradermal |
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| Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative | Biological | 0.5 mL, Intramuscular |
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| Fluzone High-Dose vaccine, 2015-2016 formulation | Biological | 0.5 mL, Intramuscular |
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| Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine |
Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroprotection was defined as the number of participants with a titer ≥ 40 (1/dilution) at pre-vaccination and 21 days post-vaccination. |
| Day 0 (Pre-vaccination) and 21 days post-vaccination |
| Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroconversion was defined as either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in titer post-vaccination. | 21 days post-vaccination |
| Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Anti-influenza antibodies were measured using an hemagglutination inhibition assay. | 21 days post-vaccination |
| Council Bluffs |
| Iowa |
| 51503 |
| United States |
| Metairie | Louisiana | 70006 | United States |
| Cincinnati | Ohio | 45249 | United States |
Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
| FG002 | Fluzone Quadrivalent Vaccine (≥ 65 Years) | Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine |
| FG003 | Fluzone High-Dose Vaccine (≥ 65 Years) | Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluzone Quadrivalent Vaccine (18 to < 65 Years) | Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine |
| BG001 | Fluzone Quadrivalent Intradermal Vaccine | Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine |
| BG002 | Fluzone Quadrivalent Vaccine (≥ 65 Years) | Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine |
| BG003 | Fluzone High-Dose Vaccine | Adults ≥ 65 years of age who received an intramuscular injection of a 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 | Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 solicited injection-site reactions: Pain, Significant; prevents daily activity. Erythema, Swelling, Induration, and Ecchymosis >100 mm. Grade 3 solicited systemic reactions: Fever, ≥ 39.0°C or ≥ 102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity. A participant (18 to < 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was excluded from the Per-protocol analysis Set and was included in the Fluzone Quadrivalent vaccine Group in the Safety Analysis Set and the assigned group in the Full Analysis Set. | The vaccine safety outcomes were assessed in the Safety Analysis Set. A participant (18 to < 65 Years) who was assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to < 65 Years) group in the Safety Analysis Set. | Posted | Number | Participants | Day 0 up to Day 7 post-vaccination |
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| Secondary | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Anti-influenza antibodies were measured using an hemagglutination inhibition assay. | Anti-influenza antibodies were assessed in the Per-protocol Analysis Set. | Posted | Geometric Mean | 95% Confidence Interval | Titers (1/dilutions) | Day 0 (pre-vaccination) and 21 days post-vaccination |
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| Secondary | Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroprotection was defined as the number of participants with a titer ≥ 40 (1/dilution) at pre-vaccination and 21 days post-vaccination. | Anti-influenza antibodies were assessed in the Per-protocol Analysis Set. | Posted | Number | Participants | Day 0 (Pre-vaccination) and 21 days post-vaccination |
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| Secondary | Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroconversion was defined as either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in titer post-vaccination. | Anti-influenza antibodies were assessed in the Per-protocol Analysis Set. | Posted | Number | Participants | 21 days post-vaccination |
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| Secondary | Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine | Anti-influenza antibodies were measured using an hemagglutination inhibition assay. | Anti-influenza antibodies were assessed in the Per-protocol Analysis Set. | Posted | Geometric Mean | 95% Confidence Interval | Titer ratio | 21 days post-vaccination |
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Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
A participant (18 to < 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to < 65 Years) Group in the Safety Analysis Set.
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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 Quadrivalent Vaccine (18 to < 65 Years) | Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine | 0 | 53 | 29 | 53 | ||
| EG001 | Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) | Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine | 0 | 51 | 29 | 51 | ||
| EG002 | Fluzone Quadrivalent Vaccine (≥ 65 Years) | Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine | 0 | 53 | 15 | 53 | ||
| EG003 | Fluzone High-Dose Vaccine (≥ 65 Years) | Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine | 1 | 51 | 22 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site Pruritus | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Injection site Pain | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Injection site Erythema | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Injection site Swelling | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Injection site Induration | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Shivering | General disorders | MedDRA 18.0 | 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 (N=53, 51, 53, 51) |
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| Injection-site Erythema (N=53, 51, 53, 51) |
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| Grade 3 Injection-site Erythema (N=53, 51, 53, 51) |
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| Injection-site Swelling (N=53, 51, 53, 51) |
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| Grade 3 Injection-site Swelling (N=53, 51, 53, 51) |
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| Injection-site Induration (N=53, 51, 53, 51) |
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| Grade 3 Injection-site Induration (N=53,51,53,51) |
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| Injection-site Ecchymosis (N=53, 51, 53, 51) |
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| Grade 3 Injection-site Ecchymosis (N=53,51,53,51) |
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| Fever (N=52, 51, 53, 51) |
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| Grade 3 Fever (N=52, 51, 53, 51) |
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| Headache (N=53, 51, 53, 51) |
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| Grade 3 Headache (N=53, 51, 53, 51) |
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| Malaise (N=53, 51, 53, 51) |
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| Grade 3 Malaise (N=53, 51, 53, 51) |
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| Myalgia (N=53, 51, 53, 51) |
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| Grade 3 Myalgia (N=53, 51, 53, 51) |
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| Shivering (N=53, 51, 53, 51) |
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| Grade 3 Shivering (N=53, 51, 53, 51) |
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Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine |
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| OG003 |
| Fluzone High-Dose Vaccine (≥ 65 Years) |
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine |
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| OG003 | Fluzone High-Dose Vaccine (≥ 65 Years) | Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine |
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Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine |
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