Home Administration of FluMist by Parents/Caregivers

NCT ID: NCT01938170

Last Updated: 2016-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-09-30

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.

Conditions

Influenza

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FluMist

Subjects receiving vaccine at home

Group Type: EXPERIMENTAL

FluMist

Intervention Type: BIOLOGICAL

Subjects receiving Flumist vaccine

Interventions

FluMist

Subjects receiving Flumist vaccine

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina

OTHER

Sponsor Role: collaborator

MedImmune LLC

INDUSTRY

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ravi Jhaveri, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27938896 (View on PubMed)

Other Identifiers

13-2769

Identifier Type: -

Identifier Source: org_study_id