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OpenTrials
Completed

NCT Number: NCT01938170

Home Administration of FluMist by Parents/Caregivers

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

FluMist

Biological

Subjects receiving Flumist vaccine

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • MedImmune LLC
  • University of North Carolina

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 10, 2013
Registry last updated
May 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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