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| ID | Type | Description | Link |
|---|---|---|---|
| UTN: U1111-1113-3648 | Other Identifier | WHO |
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The aim of the study is to generate data on key parameters associated with assessment of influenza vaccines in individuals 50-64 years of age
Primary Objective:
Participants will be randomized to receive one dose of either High-Dose Trivalent Inactivated Influenza Vaccine or Trivalent Inactivated Influenza Vaccine. They will be followed up for safety for one month post-vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Dose Trivalent Inactivated Influenza Vaccine | Experimental |
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| Trivalent Inactivated Influenza Vaccine | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Dose Trivalent Inactivated Influenza Vaccine | Biological | 0.5 mL Intramuscular |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine. | Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method. | Day 0 and Day 28 post-vaccination |
| Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method. | Day 0 and Day 28 Post-vaccination |
| Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Seroconversion: For participants with a Day 0 (pre-vaccination) titer < 10 (1/dilution [1/dil]) a titer ≥ 40 (1/dil), and for participants with a Day 0 titer ≥ 10 (1/dil) a ≥ 4 fold increase of titer on Day 28. Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method. | Day 0 and Day 28 post-vaccination |
| Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Seroprotection was defined as a titer ≥ 40 (1/dilution [1/dil]). Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method. | Day 0 and Day 28 post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Solicited Injection Site Reactions: Pain, Erythema, Swelling, Ecchymosis, and Induration. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia, and Shivering | Day 0 through Day 7 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 |
|---|---|---|---|---|---|---|
| Idaho Falls | Idaho | 83404 | United States | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 300 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants were enrolled from 15 November to 10 December 2010 in 4 clinical centers in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluzone® High-Dose Vaccine Group | Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0 |
| FG001 | Fluzone® Vaccine Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Trivalent Inactivated Influenza Vaccine | Biological | 0.5 mL, Intramuscular |
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| Columbia |
| Maryland |
| 21045 |
| United States |
| Ellicott City | Maryland | 21042 | United States |
| Missoula | Montana | 59802 | United States |
| Cleveland | Ohio | 44122 | United States |
Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluzone® High-Dose Vaccine Group | Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0 |
| BG001 | Fluzone® Vaccine Group | Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0 |
| BG002 | 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 | Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine. | Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method. | Serum antibody titers to vaccine antigens were assessed in the full analysis set population. | Posted | Geometric Mean | 95% Confidence Interval | 1/dilution (1/dil) | Day 0 and Day 28 post-vaccination |
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| Primary | Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method. | Serum antibody titers to vaccine antigens were assessed in the full analysis set population. | Posted | Geometric Mean | 95% Confidence Interval | 1/dilution (1/dil) | Day 0 and Day 28 Post-vaccination |
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| Primary | Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Seroconversion: For participants with a Day 0 (pre-vaccination) titer < 10 (1/dilution [1/dil]) a titer ≥ 40 (1/dil), and for participants with a Day 0 titer ≥ 10 (1/dil) a ≥ 4 fold increase of titer on Day 28. Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method. | Seroconversion to the vaccine antigens was assessed in the full analysis set population. | Posted | Number | Percentage of Participants | Day 0 and Day 28 post-vaccination |
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| Primary | Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Seroprotection was defined as a titer ≥ 40 (1/dilution [1/dil]). Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method. | Seroprotection was assessed in the full analysis set population. | Posted | Number | Percentage of Participants | Day 0 and Day 28 post vaccination |
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| Secondary | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine | Solicited Injection Site Reactions: Pain, Erythema, Swelling, Ecchymosis, and Induration. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia, and Shivering | Safety analysis was on all enrolled and vaccinated subjects with available reaction data, safety analysis set population. | Posted | Number | Participants | Day 0 through Day 7 post-vaccination |
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Adverse events data were collected from the day of vaccination through 28 days 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® High-Dose Vaccine Group | Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0 | 0 | 148 | 130 | 148 | ||
| EG001 | Fluzone® Vaccine Group | Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0 | 0 | 152 | 110 | 152 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Solicited Injection Site Pain | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Solicited Injection Site Erythema | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Solicited Injection Site Swelling | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Solicited Injection Site Induration | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Solicited Malaise | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Solicited Shivering | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Solicited Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Solicited Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-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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| >=65 years |
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| Male |
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| B: Brisbane - Pre-vaccination (N=147, 152) |
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| A/H1N1: California - Post-vaccination (N=145, 151) |
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| A/H3N2: Victoria - Post-vaccination (N = 145, 151) |
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| B: Brisbane - Post-vaccination (N=145, 151) |
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