Clinical trial NCT01938170: Home Administration of FluMist by Parents/Caregivers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: University of North Carolina
name: MedImmune LLC
First posted: 2013-09-10
Enrollment: 41
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Subjects That Reported Successful Home Vaccination With no Adverse Events
timeFrame: 0-12 days
Secondary outcomes:
measure: Number of Subjects That Reported Ability to Successfully Administer FluMist Vaccine at Home
timeFrame: 0-12 days
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Ravi Jhaveri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.