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| Name | Class |
|---|---|
| University of North Carolina | OTHER |
| MedImmune LLC | INDUSTRY |
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This study will examine the feasibility of having parents and caregivers administer FluMist live intranasal vaccine to their children at home outside the traditional medical environment and without the involvement of medical personnel.
The study will recruit patients and families that are already eligible to receive the FluMist vaccine. After consent is obtained and vaccine is given to the family, they will go home to administer vaccine to other members within 24 hours. Telephone follow up within 48 hours will confirm that vaccine was given successfully and within 9-12 days to assess patient preferences for giving vaccine at home and if there were any adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FluMist | Experimental | Subjects receiving vaccine at home |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FluMist | Biological | Subjects receiving Flumist vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects That Reported Successful Home Vaccination With no Adverse Events | We will assess the tolerability of giving the FluMist nasal vaccine at home by parents/caregivers to their children by performing telephone survey follow up. We will ask parents at both 24-48 hours and at 9-12 days after study visit and enrollment about any difficulties in giving FluMist at home and any adverse events encountered when giving FluMist at home. | 0-12 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects That Reported Ability to Successfully Administer FluMist Vaccine at Home | This study will also assess the feasibility of having parents/caregivers administer Flumist vaccine outside a traditional medical environment and without the direct participation of medical personnel. We will ask parents by telephone survey at both 24-48 hours and at 9-12 days after study visit and enrollment about any difficulties in giving FluMist at home, about maintaining temperature and conditions proper for vaccine storage until administration. We will also ask about ease of vaccine disposal and about child preferences for receiving vaccine at home compared to at a dedicated medical visit. |
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Inclusion Criteria:
Exclusion Criteria:
1. Children in the family receive vaccine through Vaccines for Children program
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| Name | Affiliation | Role |
|---|---|---|
| Ravi Jhaveri, MD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27938896 | Derived | Jhaveri R, Allyne K. A Feasibility Trial of Home Administration of Intranasal Vaccine by Parents to Eligible Children. Clin Ther. 2017 Jan;39(1):204-211.e4. doi: 10.1016/j.clinthera.2016.11.018. Epub 2016 Dec 7. |
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10/2014-1/2015
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| ID | Title | Description |
|---|---|---|
| FG000 | FluMist | Subjects receiving vaccine at home FluMist: Subjects receiving Flumist vaccine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FluMist | Subjects receiving vaccine at home FluMist: Subjects receiving Flumist vaccine |
| 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 |
| 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 Subjects That Reported Successful Home Vaccination With no Adverse Events | We will assess the tolerability of giving the FluMist nasal vaccine at home by parents/caregivers to their children by performing telephone survey follow up. We will ask parents at both 24-48 hours and at 9-12 days after study visit and enrollment about any difficulties in giving FluMist at home and any adverse events encountered when giving FluMist at home. | Posted | Number | participants | 0-12 days |
|
|
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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 | FluMist | Subjects receiving vaccine at home FluMist: Subjects receiving Flumist vaccine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ravi Jhaveri MD | UNC Chapel HIll | 919-962-5136 | ravi.jhaveri@unc.edu |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000613429 | FluMist |
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| 0-12 days |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Number of Subjects That Reported Ability to Successfully Administer FluMist Vaccine at Home | This study will also assess the feasibility of having parents/caregivers administer Flumist vaccine outside a traditional medical environment and without the direct participation of medical personnel. We will ask parents by telephone survey at both 24-48 hours and at 9-12 days after study visit and enrollment about any difficulties in giving FluMist at home, about maintaining temperature and conditions proper for vaccine storage until administration. We will also ask about ease of vaccine disposal and about child preferences for receiving vaccine at home compared to at a dedicated medical visit. | Posted | Number | participants | 0-12 days |
|
|
|
| 0 |
| 41 |
| 10 |
| 41 |
| Fatigue | General disorders |
|
| Sore Throat | General disorders |
|
| Fever | General disorders |
|
| Headache | General disorders |
|
| Vomiting | General disorders |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |