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To describe any degree of preference for the route of administration of Fluzone influenza vaccine, ID versus IM, in healthy adult subjects 18-49 years of age.
To collect safety data, injection site reactions, and systemic reactions, through Day 7 post-vaccination; SAEs through day 28 post-vaccination
The purpose of this clinical trial is to determine, in a relatively small sample of persons 18-49 years of age, if there is a preference trend for a particular route of administration, ID vs IM, when receiving a seasonal influenza vaccine. Uptake of influenza vaccine is disappointingly low in this age group, and there is the perception that aversion to IM injection plays a role in vaccination avoidance. The BD Micro-Injection System to be used in this study may offer a more acceptable alternative to the standard IM injection for influenza immunization and thereby promote wider acceptance of influenza vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluzone Intradermal First, Then Fluzone Intramuscular | Experimental |
| |
| Fluzone Intramuscular First, Then Fluzone Intradermal | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzone: Influenza virus vaccine | Biological | 0.1 mL, Intradermal Right deltoid, 0.5 mL, Intramuscular Left deltoid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Pain or other discomfort was assessed on a scale of 0 to 10 (None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; Unbearable = 9, 10) according to route of administration: intradermal (ID) as Group 1 and intramuscular (IM) as Group 2. Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population. | Day 0 and up to 7 days post-vaccination |
| Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Numerical scores were assigned to pain by participants on the preference questionnaire as: None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; or Unbearable = 9, 10. Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population. | Days 0, 3, and 7 after vaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Solicited injection site reactions: Pain, Pruritus, Erythema, Swelling, Induration, Ecchymosis. Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population. | Days 0 through 7 post-vaccination |
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 |
|---|---|---|---|---|---|---|
| Grove City | Pennsylvania | 16127 | United States | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 110 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants were enrolled and treated from 25 January 2008 to 11 March 2008 in 1 medical center in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluzone Intradermal First, Then Fluzone Intramuscular | Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0 |
| FG001 | Fluzone Intramuscular First, Then Fluzone Intradermal |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Fluzone: Influenza virus vaccine | Biological | 0.5 mL, Intramuscular Right deltoid, 0.1 mL, Intradermal Left deltoid |
|
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| Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection | Solicited systemic reactions: Fever (temperature); Headache; Malaise; and Myalgia. Data for this outcome were based on the first vaccination type, intradermal or intramuscular. | Days 0 through 7 post-vaccination |
| Pittsburgh |
| Pennsylvania |
| 15241 |
| United States |
Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluzone Intradermal First, Then Fluzone Intramuscular | Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0 |
| BG001 | Fluzone Intramuscular First, Then Fluzone Intradermal | Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0 |
| BG002 | 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 |
| |||||||||||||||||
| 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 | Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Pain or other discomfort was assessed on a scale of 0 to 10 (None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; Unbearable = 9, 10) according to route of administration: intradermal (ID) as Group 1 and intramuscular (IM) as Group 2. Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population. | Pain or other discomfort was assessed in the Per-Protocol Population. Data were combined for responses following a similar type of vaccination route. | Posted | Number | Participants | Day 0 and up to 7 days post-vaccination |
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| ||||||||||||||||||||||||||||||||||||
| Primary | Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Numerical scores were assigned to pain by participants on the preference questionnaire as: None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; or Unbearable = 9, 10. Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population. | Posted | Mean | Standard Deviation | Scores on a scale | Days 0, 3, and 7 after vaccination |
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| Other Pre-specified | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Solicited injection site reactions: Pain, Pruritus, Erythema, Swelling, Induration, Ecchymosis. Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population. | Safety parameters were assessed in all enrolled and vaccinated participants, intend-to-treat population. | Posted | Number | Participants | Days 0 through 7 post-vaccination |
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection | Solicited systemic reactions: Fever (temperature); Headache; Malaise; and Myalgia. Data for this outcome were based on the first vaccination type, intradermal or intramuscular. | Safety parameters were assessed in all enrolled and vaccinated subjects, intend-to-treat population. | Posted | Number | Participants | Days 0 through 7 post-vaccination |
|
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Adverse event data were collected from the day of vaccination for up to 28 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 | Fluzone Intradermal First, Then Fluzone Intramuscular | Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0 | 0 | 56 | 92 | 110 | ||
| EG001 | Fluzone Intramuscular First, Then Fluzone Intradermal | Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0 | 0 | 54 | 75 | 110 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Pain | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Injection Site Pruritus | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Injection Site Erythema | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Injection Site Swelling | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Injection Site Induration | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Injection Site Ecchymosis | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Fever | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | 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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| >=65 years |
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| Male |
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| Any - Day 3 |
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| Severe or Worse - Day 3 |
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| Any - Day 7 |
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| Severe or Worse - Day 7 |
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