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This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years.
Primary Objective:
To describe the safety profile for all subjects.
Secondary Objective:
To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.
Subjects who previously participated in study FID29 will be invited to participate in this revaccination study. They will be assigned to 1 of 3 groups based on the group they were previously randomized to and the vaccine received in study FID29.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1a: Fluzone ID After Fluzone ID | Experimental |
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| Group 1b: Fluzone IM After Fluzone ID | Experimental |
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| Group 2a: Fluzone IM After Fluzone IM | Active Comparator |
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| Group 2b: Fluzone ID After Fluzone IM | Experimental |
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| Group 3: Fluzone HD After Fluzone HD | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Virus Vaccine USP Trivalent Types A and B | Biological | 0.1 mL, Intradermal |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering. | Days 0 through 7 post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Serum antibody titers for the influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay. | Day 0 and Day 28 post-vaccination |
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Inclusion Criteria :
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | 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 807 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants were enrolled from 14 October to 20 November 2008 in 27 medical centers in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1a: Fluzone ID After Fluzone ID | Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031) |
| FG001 | Group 1b: 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 |
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| Influenza Virus Vaccine USP Trivalent Types A and B | Biological | 0.5 mL, Intramuscular |
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| Influenza Virus Vaccine USP Trivalent Types A and B | Biological | 0.1 mL, Intradermal |
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| Influenza Virus Vaccine USP Trivalent Types A and B | Biological | 0.5 mL, Intramuscular |
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| Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine |
Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28. |
| Days 0 and 28 post-vaccination |
| Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose 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 |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Chandler | Arizona | 85224 | United States |
| Mesa | Arizona | 85213 | United States |
| Phoenix | Arizona | 85014 | United States |
| Tucson | Arizona | 85710 | United States |
| Fountain Valley | California | 92708 | United States |
| San Diego | California | 92103 | United States |
| Milford | Connecticut | 06460 | United States |
| Pembroke Pines | Florida | 33024 | 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 |
| St Louis | Missouri | 63110 | 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 |
| Fort Worth | Texas | 76107 | United States |
| Galveston | Texas | 77555 | 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 |
Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
| FG002 | Group 2a: Fluzone IM After Fluzone IM | Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031) |
| FG003 | Group 2b: Fluzone ID After Fluzone IM | Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031) |
| FG004 | Group 3: Fluzone HD After Fluzone HD | Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1a: Fluzone ID After Fluzone ID | Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031) |
| BG001 | Group 1b: Fluzone IM After Fluzone ID | Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031) |
| BG002 | Group 2a: Fluzone IM After Fluzone IM | Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031) |
| BG003 | Group 2b: Fluzone ID After Fluzone IM | Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031) |
| BG004 | Group 3: Fluzone HD After Fluzone HD | Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031) |
| BG005 | 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 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering. | Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population. | Posted | Number | Participants | Days 0 through 7 post vaccination |
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| Secondary | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Serum antibody titers for the influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay. | Serum antibody 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 Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28. | Serum antibody titers were assessed in the per-protocol population. | Posted | Number | Percentage of Participants | Days 0 and 28 post-vaccination |
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| Secondary | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose 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 |
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Adverse events data were collected from the day of vaccination to 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 1a: Fluzone ID After Fluzone ID | Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031) | 10 | 295 | 239 | 292 | ||
| EG001 | Group 1b: Fluzone IM After Fluzone ID | Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031) | 3 | 98 | 42 | 98 | ||
| EG002 | Group 2a: Fluzone IM After Fluzone IM | Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031) | 6 | 105 | 54 | 105 | ||
| EG003 | Group 2b: Fluzone ID After Fluzone IM | Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031) | 3 | 108 | 86 | 107 | ||
| EG004 | Group 3: Fluzone HD After Fluzone HD | Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031) | 10 | 201 | 123 | 200 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Retroperitoneal Haematoma | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Umbilical Hernia | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Umbilical Hernia, Obstructive | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Chest Pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Non Cardiac Chest Pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Cholecystitis Acute | Hepatobiliary disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Bacterial Sepsis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Infective Exacerbation of Chronic Obstructive Airways Disease | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Lobar Pneumonia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Otitis Media Chronic | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
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| Pelvic Fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
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| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
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| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Acute Myeloid Leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
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| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
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| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
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| Cerebral Cyst | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Subarachnoid Haemorrhage | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Renal Failure Acute | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Endometrial Hyperplasia | Reproductive system and breast disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Cholecystectomy | Hepatobiliary disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Injection Site Erythema | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Injection Site Swelling | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Injection Site Induration | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Injection Site Ecchymosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
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| Injection Site Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Shivering | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.0 | 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 |
| D009976 | Orthomyxoviridae Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | 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 |
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| Grade 3 Pain (Incapacitating) |
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| Any Solicited Injection site Erythema |
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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 Ecchymosis |
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| Grade 3 Ecchymosis (≥ 5 cm) |
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| Any Solicited Injection site Pruritus |
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| Grade 3 Pruritus (Incapacitating) |
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| Any Fever |
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| Grade 3 Fever (>102.2 ºF) |
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| Any Headache |
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| Grade 3 Headache (Prevents daily activities) |
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| Any Malaise |
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| Grade 3 Malaise (Prevents daily activities) |
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| Any Myalgia |
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| Grade 3 Myalgia (Prevents daily activities) |
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| Any Shivering |
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| Grade 3 Shivering (Prevents daily activities) |
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Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031) |
| OG004 | Group 3: Fluzone HD After Fluzone HD | Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031) |
|
|
Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031) |
| OG004 | Group 3: Fluzone HD After Fluzone HD | Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031) |
|
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| OG003 |
| Group 2b: Fluzone ID After Fluzone IM |
Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031) |
| OG004 | Group 3: Fluzone HD After Fluzone HD | Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031) |
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