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Home Administration of FluMist by Parents/Caregivers

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ClinicalTrials.gov Identifier: NCT01938170
Recruitment Status : Completed
First Posted : September 10, 2013
Results First Posted : May 26, 2016
Last Update Posted : May 26, 2016
Sponsor:
Collaborators:
University of North Carolina
MedImmune LLC
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Influenza Biological: FluMist Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Assess the Acceptability, Tolerability, and Feasibility of Home Intranasal Administration of FluMist® by a Trained Primary Caregiver to Healthy Family Members 2 Through 17 Years of Age
Study Start Date : September 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Flu Shot

Arm Intervention/treatment
Experimental: FluMist
Subjects receiving vaccine at home
Biological: FluMist
Subjects receiving Flumist vaccine




Primary Outcome Measures :
  1. Number of Subjects That Reported Successful Home Vaccination With no Adverse Events [ Time Frame: 0-12 days ]
    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.


Secondary Outcome Measures :
  1. Number of Subjects That Reported Ability to Successfully Administer FluMist Vaccine at Home [ Time Frame: 0-12 days ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The primary caregiver must be 18 years of age or older and willing to give written informed consent for study participation
  2. The primary caregiver must be the parent or legal guardian of all the children in living in the household
  3. All the children in the household who are 2 through 17 years of age must receive their primary care in the clinic
  4. All the children in the household who are 2 through 17 years of age must have private insurance that will provide for the cost of influenza vaccination
  5. There must be at least one member of the household who is 2 through 17 years of age, presenting for care in the clinic, eligible to receive Live Attenuated Influenza Vaccine (LAIV) and whose primary care giver is willing to administer LAIV to them in the clinic with supervision
  6. There must be at least one family member of the household who is 2 through 17 years of age, not presenting for care in the clinic, eligible to receive LAIV and whose primary care giver is willing to administer LAIV to them in the in-home setting
  7. There must be a working refrigerator in the household
  8. The primary caregiver must have a working telephone number and be willing to be contacted for study follow-up by telephone or e-mail
  9. The primary caregiver is available for the entire study period - 12 days following the last dose of LAIV to be administered to a child
  10. The primary caregiver must agree to complete a 30 minute post vaccination assessment and an 8 day diary following vaccination for each child receiving LAIV.

Exclusion Criteria:

1. Children in the family receive vaccine through Vaccines for Children program


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938170


Locations
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United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
University of North Carolina
MedImmune LLC
Investigators
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Principal Investigator: Ravi Jhaveri, MD University of North Carolina

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01938170     History of Changes
Other Study ID Numbers: 13-2769
First Posted: September 10, 2013    Key Record Dates
Results First Posted: May 26, 2016
Last Update Posted: May 26, 2016
Last Verified: April 2016