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| ID | Type | Description | Link |
|---|---|---|---|
| UTN: U1111-1113-3619 | Other Identifier | WHO |
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The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain, and the investigational TIV containing the alternate B strain in adult subjects.
Primary Objective:
Observational Objective:
All participants will receive a single dose of their assigned vaccine during Visit 1. They will be followed up for safety and immunogenicity through Day 21 post-vaccination (Visit 2)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Investigational Quadrivalent Influenza Vaccine | Experimental | Participants will receive a dose of Investigational Quadrivalent Inactivated Influenza Vaccine |
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| Group 2: Investigational Trivalent Influenza Vaccine | Experimental | Participants will receive a dose of Investigational Trivalent Inactivated Influenza Vaccine |
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| Group 3: Licensed 2010-2011 Trivalent Influenza Vaccine | Active Comparator | Participants will receive a dose of Licensed 2010-2011 Trivalent Inactivated Influenza Vaccine |
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| Group 4: Licensed 2010-2011 Trivalent Influenza Vaccine | Active Comparator | Participants will receive a dose of Licensed 2010-2011 Trivalent Inactivated Influenza Vaccine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative | Biological | 0.5 mL, Intramuscular |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older. | Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. | Day 21 post-vaccination |
| Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. | Day 21 post-vaccination |
| Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. | Day 0 and Day 21 post-vaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines (TIV) With Corresponding B Strains in Participants Aged 65 Years and Older. | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as < 10. 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 ≥ four-fold increase in post-vaccination titer. |
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 |
|---|---|---|---|---|---|---|
| Hoover | Alabama | 35216 | United States | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 739 participants who met all the inclusion criteria and none of the exclusion criteria were enrolled, randomized and vaccinated in the study.
The study participants were enrolled from 08 October through 01 December 2010 in 12 clinic centers in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 (Investigational Quadrivalent Influenza Vaccine) | Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine |
| FG001 | Group 2 (Investigational Trivalent Influenza Vaccine) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Investigational Trivalent Inactivated Influenza Vaccine, No Preservative | Biological | 0.5 mL, Intramuscular |
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| Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative | Biological | 0.5 mL, Intramuscular |
|
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| Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative | Biological | 0.5 mL, Intramuscular |
|
|
| Day 21 post-vaccination |
| Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. 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 ≥ four-fold increase in post-vaccination titers. | Day 21 post-vaccination |
| Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 1:40 (l/dil) | Day 21 post-vaccination |
| Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. 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 ≥ four-fold increase in post-vaccination titer. | Day 21 post-vaccination |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Solicited injection site reactions: Pain, Erythema and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection site reactions: Pain - Significant; prevents daily activity; Erythema and Swelling >100 mm. Grade 3 solicited systemic reactions: Fever (Temperature) ≥102.1°F; Headache, Malaise, and Myalgia - Significant; prevents daily activity. | Day 0 up to day 21 post-vaccination |
| South Miami |
| Florida |
| 33143 |
| United States |
| Springfield | Missouri | 65802 | United States |
| New York | New York | 10004 | United States |
| Rochester | New York | 14609 | United States |
| Cincinnati | Ohio | 45249 | United States |
| Allentown | Pennsylvania | 18102 | United States |
| Bensalem | Pennsylvania | 19020 | United States |
| Warwick | Rhode Island | 02866 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Nashville | Tennessee | 37212 | United States |
| San Antonio | Texas | 78229 | United States |
Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
| FG002 | Group 3 (Licensed Trivalent Influenza Vaccine) | Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine |
| FG003 | Group 4 (Licensed Trivalent Influenza Vaccine) | Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 (Investigational Quadrivalent Influenza Vaccine) | Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine |
| BG001 | Group 2 (Investigational Trivalent Influenza Vaccine) | Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine |
| BG002 | Group 3 (Licensed Trivalent Influenza Vaccine) | Participants aged 65 years and older who received the received the Licensed 2010-2011 Trivalent Influenza Vaccine |
| BG003 | Group 4 (Licensed Trivalent Influenza Vaccine) | Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine |
| BG004 | 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 |
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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 Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older. | Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. | Geometric mean titers to the influenza vaccine B antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigens, including results reported as less or greater than lower limit of quantitation (<LLOQ or >ULOQ). | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 21 post-vaccination |
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| Other Pre-specified | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines (TIV) With Corresponding B Strains in Participants Aged 65 Years and Older. | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as < 10. 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 ≥ four-fold increase in post-vaccination titer. | Seroconversion with respect to influenza vaccine B strains (corresponding B strains) was determined in randomized and vaccinated adult participants, per-protocol population | Posted | Number | Participants | Day 21 post-vaccination |
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| Primary | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. | Geometric Mean Titers to the influenza vaccine B strains (cross-reactive antibody) were determined in randomized and vaccinated participants, per-protocol population | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 21 post-vaccination |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. 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 ≥ four-fold increase in post-vaccination titers. | Seroconversion to influenza vaccine B Strains (cross-reactive antibody) was determined in randomized and vaccinated participants, per-protocol population | Posted | Number | Participants | Day 21 post-vaccination |
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| Primary | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. | Geometric Mean Titers to the influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 and Day 21 post-vaccination |
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| Other Pre-specified | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 1:40 (l/dil) | Seroprotection to vaccine antigens were determined in randomized and vaccinated participants, per-protocol population | Posted | Number | Participants | Day 21 post-vaccination |
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| Other Pre-specified | Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. 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 ≥ four-fold increase in post-vaccination titer. | Seroconversion to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. | Posted | Number | Participants | Day 21 post-vaccination |
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| Other Pre-specified | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Solicited injection site reactions: Pain, Erythema and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection site reactions: Pain - Significant; prevents daily activity; Erythema and Swelling >100 mm. Grade 3 solicited systemic reactions: Fever (Temperature) ≥102.1°F; Headache, Malaise, and Myalgia - Significant; prevents daily activity. | Solicited injection site and systemic reactions were assessed in all randomized and vaccinated participants, safety population. | Posted | Number | Participants | Day 0 up to day 21 post-vaccination |
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Adverse events data were collected from Day 0 (post-vaccination) upto 21 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 | Group 1 (Investigational Quadrivalent Influenza Vaccine) | Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine | 0 | 225 | 73 | 225 | ||
| EG001 | Group 2 (Investigational Trivalent Influenza Vaccine) | Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine | 1 | 225 | 52 | 225 | ||
| EG002 | Group 3 (Licensed Trivalent Influenza Vaccine) | Participants aged 65 years and older who received the received the Licensed 2010-2011 Trivalent Influenza Vaccine | 2 | 225 | 64 | 225 | ||
| EG003 | Group 4 (Licensed Trivalent Influenza Vaccine) | Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine | 0 | 64 | 31 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retina detachment | Eye disorders | MedDRA, version 13.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA, version 13.0 | Non-systematic Assessment |
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| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 13.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA, version 13.0 | Non-systematic Assessment |
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| Injection site Swelling | General disorders | MedDRA, version 13.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA, version 13.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA, version 13.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA, version 13.0 | 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 |
|
| B/Florida/04/2006 (220, 221, 0, 0) |
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Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine |
| OG003 | Group 4 (Licensed Trivalent Influenza Vaccine) | Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine |
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| OG003 | Group 4 (Licensed Trivalent Influenza Vaccine) | Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine |
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Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
| OG003 | Group 4 (Licensed Trivalent Influenza Vaccine) | Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine |
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| OG003 | Group 4 (Licensed Trivalent Influenza Vaccine) | Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine |
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| OG003 | Group 4 (Licensed Trivalent Influenza Vaccine) | Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine |
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| OG003 | Group 4 (Licensed Trivalent Influenza Vaccine) | Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine |
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| OG003 | Group 4 (Licensed Trivalent Influenza Vaccine) | Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine |
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