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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1124-8066 | Other Identifier | WHO |
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The aim of the study is to demonstrate safety and immunogenicity of the quadrivalent influenza intradermal (QIV-ID) vaccine compared to the trivalent influenza vaccine (TIV) containing the B strain from the primary (Yamagata) lineage (TIV-ID1) and the trivalent influenza vaccine containing B strain from the alternate (Victoria) lineage (TIV-ID2) vaccines in producing protection against four strains of influenza virus.
Primary Objective:
Secondary Objectives:
Observational Objectives:
All participants will receive a single dose of their assigned vaccine on Day 0. A subset of the participants will be assessed for immunologic response on Day 0 before vaccination and Day 28 after vaccination. All subjects will be monitored for safety for up to 6 months after vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QIV ID Vaccine Group | Experimental | Participants will receive the intradermal quadrivalent influenza vaccine |
|
| TIV ID1 Vaccine Group | Active Comparator | Participants will receive the trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage |
|
| TIV ID2 Group | Active Comparator | Participants will receive the intradermal trivalent influenza vaccine containing B strain from the alternate (Victoria) lineage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation | Biological | 0.1mL, Intradermal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. | Day 28 post-vaccination |
| Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroconversion was defined as titer< 10 (1/dil) on Day 0 and post injection titer ≥ 40 (1/dil) on Day 28, or titer ≥10 (1/dil) on Day 0 and a ≥4 fold increase in titer (1/dil) on Day 28). | Day 28 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. | Day 0 (pre-vaccination) and Day 28 post-vaccination |
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Inclusion 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 | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25613721 | Background | Gorse GJ, Falsey AR, Ozol-Godfrey A, Landolfi V, Tsang PH. Safety and immunogenicity of a quadrivalent intradermal influenza vaccine in adults. Vaccine. 2015 Feb 25;33(9):1151-9. doi: 10.1016/j.vaccine.2015.01.025. Epub 2015 Jan 19. | |
| 31537446 | Derived | Small RD, Ozol-Godfrey A, Yan L. On the use of nonparametric tests for comparing immunological Reverse Cumulative distribution curves (RCDCs). Vaccine. 2019 Oct 16;37(44):6737-6742. doi: 10.1016/j.vaccine.2019.09.007. Epub 2019 Sep 16. |
| Label | URL |
|---|---|
| Related Info | View source |
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A total of 3360 participants who met all of the inclusion and none of the exclusion criteria were randomized, 3355 received one of the trial vaccines and their data are presented in this report.
The study participants were enrolled from 22 October 2012 to 28 May 2013 at 38 clinic sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | QIV ID Vaccine Group | Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine |
| FG001 | TIV ID1 Vaccine Group | Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal | Biological | 0.1mL, Intradermal |
|
|
| Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal | Biological | 0.1mL, Intradermal |
|
|
| Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroprotection was defined as titer ≥ 40 [1/dil] at baseline and 28 days after vaccination. | Day 0 (pre-vaccination) and Day 28 post-vaccination |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Solicited injection site: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain and Pruritus Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis >100 mm. Grade 3 systemic reactions: Fever ≥39˚C; Headache, Malaise, Myalgia, and Shivering Significant preventing daily activity. | Day 0 up to Day 7 post-vaccination |
| Huntsville |
| Alabama |
| 35802 |
| United States |
| Chandler | Arizona | 85224 | United States |
| Mesa | Arizona | 85213 | United States |
| Phoenix | Arizona | 85020 | United States |
| Tucson | Arizona | 85704 | United States |
| Chula Vista | California | 91911 | United States |
| Sacramento | California | 95816 | United States |
| San Diego | California | 92103 | United States |
| Milford | Connecticut | 06460 | United States |
| Coral Gables | Florida | 33134 | United States |
| Melbourne | Florida | 32935 | United States |
| Pinellas Park | Florida | 33781 | United States |
| South Miami | Florida | 33143 | United States |
| Boise | Idaho | 83642 | United States |
| Iowa City | Iowa | 52242 | United States |
| Overland Park | Kansas | 66212 | United States |
| Wichita | Kansas | 67207 | United States |
| Kansas City | Missouri | 64114 | United States |
| Springfield | Missouri | 65802 | United States |
| St Louis | Missouri | 63104 | United States |
| Omaha | Nebraska | 68134 | United States |
| Binghamton | New York | 13901 | United States |
| Rochester | New York | 14609 | United States |
| Rochester | New York | 14621 | United States |
| Allentown | Pennsylvania | 18102 | United States |
| Bensalem | Pennsylvania | 19020 | United States |
| Warwick | Rhode Island | 02886 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Dakota Dunes | South Dakota | 57049 | United States |
| Austin | Texas | 78745 | United States |
| Fort Worth | Texas | 76107 | United States |
| Fort Worth | Texas | 76135 | United States |
| San Angelo | Texas | 76904 | United States |
| Salt Lake City | Utah | 84109 | United States |
| Salt Lake City | Utah | 84121 | United States |
| West Jordan | Utah | 84088 | United States |
| Marshfield | Wisconsin | 54449 | United States |
| FG002 | TIV ID2 Vaccine Group | Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | QIV ID Vaccine Group | Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine |
| BG001 | TIV ID1 Vaccine Group | Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1) |
| BG002 | TIV ID2 Vaccine Group | Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2) |
| 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 | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. | Geometric mean titers against the influenza virus antigens were assessed in the Per-protocol Analysis Set. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 28 post-vaccination |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroconversion was defined as titer< 10 (1/dil) on Day 0 and post injection titer ≥ 40 (1/dil) on Day 28, or titer ≥10 (1/dil) on Day 0 and a ≥4 fold increase in titer (1/dil) on Day 28). | Seroconversion to the influenza virus antigens were assessed in the Per Protocol Analysis Set. | Posted | Number | Participants | Day 28 post-vaccination |
| |||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. | Geometric mean titers against the influenza virus antigens were assessed in the Per Protocol Analysis Set. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 (pre-vaccination) and Day 28 post-vaccination |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroprotection was defined as titer ≥ 40 [1/dil] at baseline and 28 days after vaccination. | Seroprotection against influenza virus antigens was assessed in the Per Protocol Analysis Set. | Posted | Number | Participants | Day 0 (pre-vaccination) and Day 28 post-vaccination |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Solicited injection site: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain and Pruritus Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis >100 mm. Grade 3 systemic reactions: Fever ≥39˚C; Headache, Malaise, Myalgia, and Shivering Significant preventing daily activity. | Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set. | Posted | Number | Participants | Day 0 up to Day 7 post-vaccination |
|
Adverse event data were collected from Day 0 (post-vaccination) up to 6 months 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 | QIV ID Vaccine Group | Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine | 20 | 1,672 | 883 | 1,672 | ||
| EG001 | TIV ID1 Vaccine Group | Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1) | 14 | 837 | 395 | 837 | ||
| EG002 | TIV ID2 Vaccine Group | Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2) | 11 | 846 | 420 | 846 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Aortic valve disease | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dysplasia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pneumonia primary atypical | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Neck injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hemiplegic migraine | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cervical incompetence | Pregnancy, puerperium and perinatal conditions | MedDRA 15.0 | Non-systematic Assessment |
| |
| Conversion disorder | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site Pain | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Injection site Erythema | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Injection site Swelling | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Injection site Induration | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Injection site Pruritus | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Shivering | General disorders | MedDRA 15.0 | 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 |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|
| B/Texas/6/2011 (B1; N=1041, 539, 533) |
|
| B/Brisbane/60/2008 (B2; N=1041, 538, 533) |
|
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| Units | Counts |
|---|---|
| Participants |
|
|
|
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Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
|
|