Trial Outcomes & Findings for Home Administration of FluMist by Parents/Caregivers (NCT NCT01938170)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

0-12 days

Results posted on

2016-05-26

Participant Flow

10/2014-1/2015

Participant milestones

Participant milestones
Measure	FluMist Subjects receiving vaccine at home FluMist: Subjects receiving Flumist vaccine
Overall Study STARTED	41
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Home Administration of FluMist by Parents/Caregivers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FluMist n=41 Participants Subjects receiving vaccine at home FluMist: Subjects receiving Flumist vaccine
Age, Categorical <=18 years	41 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	18 Participants n=93 Participants
Sex: Female, Male Male	23 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	FluMist n=41 Participants Subjects receiving vaccine at home FluMist: Subjects receiving Flumist vaccine
Number of Subjects That Reported Successful Home Vaccination With no Adverse Events	41 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	FluMist n=41 Participants Subjects receiving vaccine at home FluMist: Subjects receiving Flumist vaccine
Number of Subjects That Reported Ability to Successfully Administer FluMist Vaccine at Home	41 participants

Adverse Events

FluMist

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	FluMist n=41 participants at risk Subjects receiving vaccine at home FluMist: Subjects receiving Flumist vaccine
Respiratory, thoracic and mediastinal disorders Rhinorrhea	9.8% 4/41 • Number of events 4
General disorders Fatigue	4.9% 2/41 • Number of events 2
General disorders Sore Throat	2.4% 1/41 • Number of events 1
General disorders Fever	2.4% 1/41 • Number of events 1
General disorders Headache	2.4% 1/41 • Number of events 1
General disorders Vomiting	2.4% 1/41 • Number of events 1

Additional Information

Ravi Jhaveri MD

UNC Chapel HIll

Phone: 919-962-5136

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place