Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary Objective:
To describe the immune response to a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.
Secondary Objective:
To describe the safety following a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.
This is a multi-center study in healthy adult subjects. All subjects will receive a single dose of one of the influenza vaccine formulations and will provide blood samples for immunogenicity assessment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Standard-dose Cell-based Influenza Vaccine | Experimental | Participants will receive a single dose of standard-dose cell-based influenza virus vaccine. |
|
| Group 2: High-dose Cell-based Influenza Vaccine | Experimental | Participants will receive a single dose of high-dose cell-based influenza virus vaccine. |
|
| Group 3: Licensed Fluzone® Influenza Vaccine | Active Comparator | Participants will receive a single dose of licensed Fluzone® influenza vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza virus vaccine - cell based (2007-2008 Formulation) | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. | Days 0 and 21 post-vaccination | |
| Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. | Seroprotection was defined as a titer ≥ 40 1/dil, and determined in participants with a valid serology result for the particular Flu strain, including results reported as less than lower limit of quantitation (LLOQ) | Day 21 post-vaccination |
| Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine. | Seroconversion: For participants with a Day 0 pre-vaccination titer < 10 (1/dil), titer ≥ 40 (1/dil) on Day 21. Significant Increase: For participants with a Day 0 pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of titer on Day 21. | Day 21 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Solicited Injection Site Reactions: Pain, erythema or redness, swelling, ecchymosis, and induration. Solicited Systemic Reactions: Fever (temperature), headache, malaise, myalgia, and rigors. | Day 0 up to Day 7 post-vaccination |
Not provided
Inclusion Criteria :
Exclusion Criteria :
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoover | Alabama | 35216 | United States | |||
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
A total of 729 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
Participants were enrolled from 16 to 23 October 2007 in 15 clinical centers in the US.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Standard Dose Cell-Based Influenza Vaccine | Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly. |
| FG001 | Group 2: High-dose Cell-Based Influenza Vaccine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Influenza virus vaccine - cell-based (2007-2008 Formulation) | Biological | 1.0 mL, Intramuscular |
|
| Influenza virus vaccine (2007-2008 Formulation) | Biological | 0.5 mL, Intramuscular |
|
|
| Mobile |
| Alabama |
| 36608 |
| United States |
| Tucson | Arizona | 85710 | United States |
| Milford | Connecticut | 06460 | United States |
| Pinellas Park | Florida | 33781 | United States |
| Chicago | Illinois | 60610 | United States |
| Wichita | Kansas | 67207 | United States |
| Kansas City | Missouri | 64114 | United States |
| Springfield | Missouri | 65802 | United States |
| Cary | North Carolina | 27518 | United States |
| Raleigh | North Carolina | 27609 | United States |
| Cincinnati | Ohio | 45249 | United States |
| Bensalem | Pennsylvania | 19020 | United States |
| Warwick | Rhode Island | 02886 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
| FG002 | Group 3: Licensed Fluzone® Influenza Vaccine | Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Standard Dose Cell-Based Influenza Vaccine | Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly. |
| BG001 | Group 2: High-dose Cell-Based Influenza Vaccine | Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly. |
| BG002 | Group 3: Licensed Fluzone® Influenza Vaccine | Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. | Geometric mean titers were assessed in the full analysis set population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Days 0 and 21 post-vaccination |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. | Seroprotection was defined as a titer ≥ 40 1/dil, and determined in participants with a valid serology result for the particular Flu strain, including results reported as less than lower limit of quantitation (LLOQ) | Seroprotection was assessed in the full analysis set population. | Posted | Number | Percentage of Participants | Day 21 post-vaccination |
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine. | Seroconversion: For participants with a Day 0 pre-vaccination titer < 10 (1/dil), titer ≥ 40 (1/dil) on Day 21. Significant Increase: For participants with a Day 0 pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of titer on Day 21. | Seroconversion and significant increase in Influenza vaccine antibodies were assessed in the full analysis set population. | Posted | Number | Percentage of Participants | Day 21 post-vaccination |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. | Solicited Injection Site Reactions: Pain, erythema or redness, swelling, ecchymosis, and induration. Solicited Systemic Reactions: Fever (temperature), headache, malaise, myalgia, and rigors. | Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population. | Posted | Number | Participants | Day 0 up to Day 7 post-vaccination |
|
Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
Not provided
Not provided
| 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: Standard Dose Cell-Based Influenza Vaccine | Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly. | 3 | 244 | 158 | 244 | ||
| EG001 | Group 2: High-dose Cell-Based Influenza Vaccine | Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly. | 4 | 241 | 179 | 241 | ||
| EG002 | Group 3: Licensed Fluzone® Influenza Vaccine | Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly. | 6 | 244 | 199 | 244 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Biliary Dyskinesia | Hepatobiliary disorders | MeDRA | Non-systematic Assessment |
| |
| Gallbladder Non-functioning | Hepatobiliary disorders | MeDRA | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MeDRA | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MeDRA | Non-systematic Assessment |
| |
| Gastrointestinal Stoma Complication | Injury, poisoning and procedural complications | MeDRA | Non-systematic Assessment |
| |
| Pelvic Fracture | Injury, poisoning and procedural complications | MeDRA | Non-systematic Assessment |
| |
| Tibia Fracture | Injury, poisoning and procedural complications | MeDRA | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MeDRA | Non-systematic Assessment |
| |
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MeDRA | Non-systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MeDRA | Non-systematic Assessment |
| |
| Loss of Consciousness | Nervous system disorders | MeDRA | Non-systematic Assessment |
| |
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MeDRA | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MeDRA | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MeDRA | Non-systematic Assessment |
| |
| Ovarian Cyst Ruptured | Reproductive system and breast disorders | MeDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site Pain | General disorders | MeDRA | Systematic Assessment |
| |
| Injection site Erythema | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Injection site Swelling | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Injection site Ecchymosis | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Injection site Induration | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Rigors | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| A/H1N1: Solomon Islands, Day 21 (N= 236, 232, 238) |
|
| A/H3N2: Wisconsin, Day 0 (N = 236, 232, 237) |
|
| A/H3N2: Wisconsin, Day 21 (N = 236, 230, 238) |
|
| B: Malaysia, Day 0 (N = 236, 233, 238) |
|
| B: Malaysia, Day 21 (nN= 235, 233, 237) |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|