Home Administration of FluMist by Parents/Caregivers
| Status: | Completed |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 2 - 17 |
| Updated: | 3/16/2015 |
| Start Date: | September 2014 |
| End Date: | June 2015 |
| Contact: | Ravi Jhaveri, M.D. |
| Email: | ravi.jhaveri@unc.edu |
| Phone: | 919-962-5136 |
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
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.
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.
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
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