InfluenzaNCT01938170
Home Administration of FluMist by Parents/Caregivers
A study testing FluMist in people with Influenza, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- FluMist
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
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- 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.
Who cannot join
- 1. Children in the family receive vaccine through Vaccines for Children program
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
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
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
- Being tested
- FluMist
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluMistBiological
Subjects receiving Flumist vaccine
| Study group | Role | What they receive |
|---|---|---|
| FluMist | Experimental | Subjects receiving vaccine at home Receives: Biological: FluMist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-12 days
Secondary outcomes (1)
Number of Subjects That Reported Ability to Successfully Administer FluMist Vaccine at Home
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.
Measured: 0-12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startSep 2014
- Primary completionApr 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, MedImmune LLC
- Responsible party
- Sponsor
- Investigators
- Ravi Jhaveri, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938170
- Sponsor's protocol ID
- 13-2769
- Status last verified
- Apr 2016
- First submitted
- 23 Aug 2013
- Last updated
- 26 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 27938896
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01938170
- Acronym / sponsor ID
- 13-2769
- Conditions
- Influenza
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- University of North Carolina, MedImmune LLC
- Study start
- Sep 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Posted 26 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FluMist | Experimental | Biological: FluMistSubjects receiving vaccine at home |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Children in the family receive vaccine through Vaccines for Children program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluMistSubjects receiving Flumist vaccine | Biological | FluMist |
Primary outcome
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.
1 secondary outcome
Number of Subjects That Reported Ability to Successfully Administer FluMist Vaccine at Home
Time frame: 0-12 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27938896Jhaveri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravi Jhaveri, MD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FluMist in people with Influenza, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects That Reported Successful Home Vaccination With no Adverse Events (time frame: 0-12 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01938170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2016.