Home Administration of FluMist by Parents/Caregivers

NCT01938170 | Completed Results

• 1 other identifier: 13-2769
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of Subjects That Reported Ability to Successfully Administer FluMist Vaccine at Home

  0-12 days

Study Arms (1)

FluMist

EXPERIMENTAL

Subjects receiving vaccine at home

Biological: FluMist

Interventions

FluMist BIOLOGICAL

Subjects receiving Flumist vaccine

FluMist

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The primary caregiver must be 18 years of age or older and willing to give written informed consent for study participation
• The primary caregiver must be the parent or legal guardian of all the children in living in the household
• All the children in the household who are 2 through 17 years of age must receive their primary care in the clinic
• 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
• 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
• 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
• There must be a working refrigerator in the household
• The primary caregiver must have a working telephone number and be willing to be contacted for study follow-up by telephone or e-mail
• The primary caregiver is available for the entire study period - 12 days following the last dose of LAIV to be administered to a child
• 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.

You may not qualify if:

• \. Children in the family receive vaccine through Vaccines for Children program

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• University of North Carolina: collaborator
• MedImmune LLC: collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• 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.

  PMID: 27938896 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

FluMist

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Ravi Jhaveri MD
• Organization: UNC Chapel HIll

ravi.jhaveri@unc.edu

919-962-5136

Study Officials

• Ravi Jhaveri, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: September 10, 2013
• Study Start: September 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 26, 2016
• Results First Posted: May 26, 2016

Record last verified: 2016-04

Locations

US (1)