Fever and Wheezing Events in Children After US Influenza... | NCT02295007

Studies
Fever and Wheezing Events in Children After US Influenza Vaccines Using Text Messaging

NCT02295007

Sponsor

Columbia University

Status

Completed

Last Update Posted

May 12, 2016Estimated

Enrollment

266Actual

Phase

Not Applicable

Conditions

Fever
Wheezing

Interventions

text message

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Apr 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Nov 17, 2014

First Submission Date that Met QC Criteria

Nov 17, 2014

First Posted Date

Nov 19, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2016

Last Update Posted Date

May 12, 2016Estimated

Name	Class
Centers for Disease Control and Prevention	FED
Boston Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Children 2-11 years of age who are given the influenza vaccine (inactivated influenza (IIV) or live attenuated influenza vaccine (LAIV)) as part of their routine care can enroll in this study if their parent has the ability to receive and send text messages. Children enrolled in this study will be observed daily for an eight-day period starting on the day of vaccine administration, and then continuing over the next 7 days, and then weekly for 42 days. On the day of enrollment and nightly for the next seven days, the parent will report via text message what their child's highest temperature is. If fever is present, they will then be prompted for additional information including other symptoms, antipyretic use and medical care sought. On day 3 as well as weekly from day 7 through day 42 post-vaccination, parents will be asked via text message about breathing problems, specifically cough, wheezing and chest tightness. They will also be asked about medications taken and care sought. The purpose of this study is to assess the feasibility of collecting this data.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

266Actual

Label	Type	Description	Intervention Names
text message	Other	all families will receive text messages to which they can respond to report symptoms	Behavioral: text message

Name	Type	Description	Arm Group Labels	Other Names
text message	Behavioral		text message

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
feasibility reporting respiratory symptom	Response rates to text messages regarding wheezing, cough or chest tightness symptoms	days 0-42 days post-vaccination

Secondary Outcomes

Measure	Description	Time Frame
feasibility reporting fever	Response rates to text messages regarding temperature	days 0-7 days post-vaccination

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

are 2 through 11years of age,
have a visit at a study site anytime during the study period,
receive first dose or second dose of LAIV4 or IIV in the season,
the parent has a cell phone with text messaging capabilities, and
the parent and child > 7 years of age speaks English or Spanish at the Columbia sites or English at the Boston site.

Exclusion criteria:

presence of fever ≥100.4 at time of vaccination,
administration of any antipyretic in the 6-hour period prior to vaccination,
stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever,
parent only speaks a language other than English or Spanish at the Columbia sites or English at the Boston site.
enrollee is a child >7 years of age who only speaks a language other than English or Spanish at the Columbia sites or English at the Boston site.
parent's inability to read and send text messages,
sibling already enrolled this season (OR cell phone # already used for another child)
chronic medical condition considered by ACIP to be a precaution or contraindication for LAIV1 (except for asthma),
current asthma exacerbation, or exacerbation in the last 2 weeks
use of oral or other systemic steroid within the last 2 weeks

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Melissa Stockwell, MD MPH	Columbia University	Principal Investigator
Philip LaRussa, MD	Columbia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centers for Disease Control and Prevention		Atlanta	Georgia	30333	United States
Boston Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29089191	Derived	Stockwell MS, Marchant CD, Wodi AP, Barnett ED, Broder KR, Jakob K, Lewis P, Kattan M, Rezendes AM, Barrett A, Sharma D, Fernandez N, LaRussa P. A multi-site feasibility study to assess fever and wheezing in children after influenza vaccines using text messaging. Vaccine. 2017 Dec 15;35(50):6941-6948. doi: 10.1016/j.vaccine.2017.10.073. Epub 2017 Oct 28.

ID	Term
D005334	Fever
D012135	Respiratory Sounds

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D012818	Signs and Symptoms, Respiratory