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| ID | Type | Description | Link |
|---|---|---|---|
| UTN: U1111-1111-5095 | Other Identifier | WHO |
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The purpose of this study is to generate additional data on the immunogenicity and safety of revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine.
Primary Objective:
Secondary Objective:
All participants, who previously received either Fluzone ID or Fluzone IM in Study FID31 (NCT 00772109), will receive one dose of either the same or the alternative vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Fluzone ID After Fluzone ID | Experimental | Participants will receive Fluzone intradermal (ID) following Fluzone ID in Study FID31 |
|
| Group 2: Fluzone IM After Fluzone ID | Experimental | Participants will receive Fluzone intramuscular (IM) following Fluzone ID in Study FID31 |
|
| Group 3: Fluzone IM After Fluzone IM | Experimental | Participants will receive Fluzone intramuscular (IM) following Fluzone IM in Study FID31 |
|
| Group 4: Fluzone ID After Fluzone IM | Experimental | Participants will receive Fluzone intradermal (ID) following Fluzone intramuscular (IM) in Study FID31 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Virus Vaccine USP Trivalent Types A and B | Biological | 0.1 mL, Intradermal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Solicited injection site reactions: Erythema (redness), Swelling, Induration, Pain, Pruritus, Ecchymosis. Solicited systemic reactions: Headache, Myalgia, Malaise, Shivering, Fever (temperature). | Day 0 through Day 7 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Serum antibody titers for influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay. | Day 0 and Day 28 post-vaccination |
| Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. |
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Inclusion Criteria :
Exclusion Criteria :
Temporary Exclusion Criteria:
A prospective subject should not be included in the study until the following conditions and/or symptoms are resolved:
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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 1248 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants were enrolled and from 23 September 2009 to 16 October 2009 in 46 medical centers in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Fluzone ID After Fluzone ID | Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109) |
| FG001 | Group 2: Fluzone IM After Fluzone ID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Influenza Virus Vaccine USP Trivalent Types A and B | Biological | 0.5 mL, Intramuscular |
|
|
| Influenza Virus Vaccine USP Trivalent Types A and B | Biological | 0.5 mL, Intramuscular |
|
|
| Influenza Virus Vaccine USP Trivalent Types A and B | Biological | 0.1 mL, Intradermal |
|
Seroprotection was defined as a hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28 post-vaccination. |
| Day 28 post-vaccination |
| Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Seroconversion was defined as either a pre vaccination hemagglutinin inhibition (HAI) titer < 1:10 and a post vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post-vaccination. | Day 28 post vaccination |
| Huntsville |
| Alabama |
| 35802 |
| United States |
| Mobile | Alabama | 36608 | United States |
| Chandler | Arizona | 85224 | United States |
| Mesa | Arizona | 85213 | United States |
| Tempe | Arizona | 85282 | United States |
| Tucson | Arizona | 85711 | United States |
| Fountain Valley | California | 92708 | United States |
| San Diego | California | 92103 | United States |
| Milford | Connecticut | 06460 | United States |
| Melbourne | Florida | 32935 | United States |
| Pembroke Pines | Florida | 33024 | United States |
| Pinellas Park | Florida | 33781 | United States |
| Boise | Idaho | 83642 | United States |
| Chicago | Illinois | 60610 | United States |
| Iowa City | Iowa | 52242 | United States |
| Wichita | Kansas | 67207 | United States |
| Lexington | Kentucky | 40509 | United States |
| Madisonville | Kentucky | 42431 | United States |
| Rockville | Maryland | 20850 | United States |
| Kansas City | Missouri | 64114 | United States |
| Springfield | Missouri | 65802 | United States |
| St Louis | Missouri | 63104 | United States |
| Albuquerque | New Mexico | 87108 | United States |
| Binghamton | New York | 13901 | United States |
| Endwell | New York | 13760 | United States |
| Rochester | New York | 14609 | United States |
| Rochester | New York | 14621 | United States |
| Cary | North Carolina | 27518 | United States |
| Raleigh | North Carolina | 27609 | United States |
| Cincinnati | Ohio | 45249 | 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 |
| Nashville | Tennessee | 37203 | United States |
| Austin | Texas | 78705 | 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 |
| San Juan | 00918 | Puerto Rico |
Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
| FG002 | Group 3: Fluzone IM After Fluzone IM | Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109) |
| FG003 | Group 4: Fluzone ID After Fluzone IM | Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Fluzone ID After Fluzone ID | Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109) |
| BG001 | Group 2: Fluzone IM After Fluzone ID | Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109) |
| BG002 | Group 3: Fluzone IM After Fluzone IM | Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109) |
| BG003 | Group 4: Fluzone ID After Fluzone IM | Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109) |
| 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 |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| 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 Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Solicited injection site reactions: Erythema (redness), Swelling, Induration, Pain, Pruritus, Ecchymosis. Solicited systemic reactions: Headache, Myalgia, Malaise, Shivering, Fever (temperature). | Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population. | Posted | Number | Participants | Day 0 through Day 7 post-vaccination |
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| |||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Serum antibody titers for influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay. | Serum antibody geometric mean titers were assessed in the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 and Day 28 post-vaccination |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. | Seroprotection was defined as a hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28 post-vaccination. | Serum antibody titers were assessed in the per-protocol population. | Posted | Number | Percentage of Participants | Day 28 post-vaccination |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine | Seroconversion was defined as either a pre vaccination hemagglutinin inhibition (HAI) titer < 1:10 and a post vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post-vaccination. | Serum antibody titers were assessed in the per protocol population. | Posted | Number | Percentage of Participants | Day 28 post vaccination |
|
Adverse events data were collected from the day of vaccination for 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 | Group 1: Fluzone ID After Fluzone ID | Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109) | 9 | 507 | 412 | 507 | ||
| EG001 | Group 2: Fluzone IM After Fluzone ID | Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109) | 2 | 252 | 148 | 252 | ||
| EG002 | Group 3: Fluzone IM After Fluzone IM | Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109) | 3 | 243 | 147 | 243 | ||
| EG003 | Group 4: Fluzone ID After Fluzone IM | Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109) | 5 | 246 | 183 | 246 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Autoimmune thyroiditis | Endocrine disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
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| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
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| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
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| Pituitary tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
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| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
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| Affective disorder | Psychiatric disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Psychiatric decompensation | Psychiatric disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Cervix haemorrhage uterine | Reproductive system and breast disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Knee arthroplasty | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Spinal operation | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Arteriovenous fistula | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Embolism venous | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Injection site pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Injection site pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Injection site ecchymosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Shivering | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Fever | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.0 | 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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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Grade 3 Erythema (≥ 5 cm) |
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| Any Solicited Injection Site Swelling |
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| Grade 3 Swelling (≥ 5 cm) |
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| Any Solicited Injection Site Induration |
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| Grade 3 Induration (≥ 5 cm) |
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| Any Solicited Injection Site Pain |
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| Grade 3 Pain (Incapacitating) |
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| Any Solicited Injection Site Pruritus |
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| Grade 3 Pruritus (Incapacitating) |
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| Any Solicited Injection Site Ecchymosis |
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| Grade 3 Ecchymosis (≥ 5 cm) |
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| Any Headache |
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| Grade 3 Headache (Prevents Daily Activities) |
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| Any Myalgia |
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| Grade 3 Myalgia (Prevents Daily Activities) |
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| Any Malaise |
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| Grade 3 Malaise (Prevents Daily Activities) |
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| Any Shivering |
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| Grade 3 Shivering (Prevents Daily Activities) |
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| Any Fever |
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| Grade 3 Fever (> 102.2 ºF) |
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Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109) |
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Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
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Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109) |
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