Home Administration of FluMist by Parents/Caregivers
|ClinicalTrials.gov Identifier: NCT01938170|
Recruitment Status : Completed
First Posted : September 10, 2013
Results First Posted : May 26, 2016
Last Update Posted : May 26, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: FluMist||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||September 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||September 2015|
Subjects receiving vaccine at home
Subjects receiving Flumist vaccine
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938170
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Ravi Jhaveri, MD||University of North Carolina|