AsthmaticPhase 4NCT02967393

Influenza Vaccine Feasibility Study in Children With Persistent Asthma

A Phase 4 study testing ccIIV4 and IIV4 in people with Asthmatic, run by Vanderbilt University Medical Center at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 5 to 11 years
Conditions the study is for: Asthmatic
What is being tested?: ccIIV4 and IIV4
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 4 sitesUnited States
Study dates: 10 Oct 2016to 1 Feb 2017
Phase: Phase 4
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 5 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Children between 5-11 years of age, inclusive, at enrollment.
Participant must have a current diagnosis of persistent asthma.
Parent/legal guardian must provide written informed consent and subject must provide assent as appropriate for age prior to initiation of study procedures and according to local Institutional Review Board (IRB) requirement.
Parent/legal guardian and subject must be willing and able to comply with planned study procedures and be available for all study visits.
Children aged 5-8 years must have received at least 2 doses of seasonal trivalent or quadrivalent influenza vaccine prior to the current influenza season. Children 9-11 years must have received at least 1 dose of seasonal trivalent or quadrivalent influenza vaccine prior to the current influenza season.
Is in good health, other than their asthma, as determined by medical history and targeted physical examination based on medical history.
English or Spanish literate.
Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls and collection of information.

Who cannot join

Acute illness and/or a reported oral temperature of ≥ 100.4°F within 72 hours prior to enrollment (this may result in a temporary delay of vaccination.
Use of antipyretic medication during the preceding 24 hours that might mask a fever (temporary deferral).
History of a severe allergic reaction (e.g., anaphylaxis) to any component of study influenza vaccines or a known allergy to eggs.
Receipt of any licensed vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to vaccination or planned receipt of any licensed vaccine within 42 days after vaccination.
Receipt of current year's licensed influenza vaccine.
Received an investigational agent (licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication) in the 28 days prior to enrollment or planned receipt before 42 days after vaccination.

Show all 14Show fewer

Has immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
Has taken ≥ 20mg/day of prednisone or its equivalent, for 14 days or more within the past 28 days.
Has know active neoplasm or a history of any hematologic malignancy.
Has had a previous exacerbation of their asthma symptoms requiring systemic steroids within the prior 28 days, or has had a life-threatening exacerbation of asthma in the past two years (e.g. hypoxic seizure, mechanical ventilation).
History of Guillian-Barre syndrome within 6 weeks of previous influenza vaccination.
Has any condition that, in the opinion of the investigator, would interfere with the evaluation of the responses or would place the participant at unacceptable risk of injury.
Has any diagnosis, current or past, of schizophrenia, bipolar disease, or other major psychiatric disorder.
Currently taking aspirin or aspirin-containing products.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Centers for Disease Control and Prevention
Atlanta, Georgia, 30329
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Duke Clinical Vaccine Unit
Durham, North Carolina, 27705
Vanderbilt Vaccine Research Program
Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: Feasibility Study to Assess the Safety of Quadrivalent, Live Attenuated Influenza Vaccine (LAIV4) Versus Quadrivalent Inactivated Influenza Vaccine (IIV4) in Children Aged 5-11 Years With Persistent Asthma of Varied Severity (Cell Culture Quadrivalent IIV Used as Surrogate for LAIV4)

This study is designed to note whether a larger safety study using quadrivalent live attenuated influenza vaccine (LAIV4) versus quadrivalent inactivated influenza vaccine (IIV4)(FLUARIX®), would be feasible in children with persistent asthma. Half of the patients in this study will receive the FLUARIX® influenza vaccine, while the other half will receive a cell cultured quadrivalent inactivated influenza vaccine (ccIIV4)(Flucelvax®) being used as a surrogate for LAIV4.

Read the detailed description

The association of an increased risk in wheezing following receipt of a live-attenuated influenza vaccine in children at least 2 years of age with a prior history of asthma or wheeze remains unclear.

The Centers for Disease Control (CDC) and Prevention's Clinical Immunization Safety Assessment (CISA) planned to address a data safety gap regarding use of LAIV4 vaccine in children with asthma by conducting a 3-site randomized, non-inferiority prospective study. The main goal was to compare the safety of LAIV4 versus IIV4 in children 5-11 years with persistent asthma during the 2016-2017 influenza season. CDC and the CISA study sites developed a protocol and associated materials, and were poised to begin enrollment early during the 2016-2017 influenza season. However, after the June 22, 2016 Advisory Committee on Immunization Practices (ACIP) vote recommending against use of LAIV4 during the 2016-2017 influenza season, CDC and study investigators decided to defer implementing a study using LAIV4 during the 2016-2017 influenza season. Investigators will reconsider initiating this study during the 2017-2018 influenza season if ACIP votes to reinstate LAIV4 use or new data become available; ACIP makes recommendations annually.

The planned LAIV4 study had unique features in its design that previously had not been implemented in vaccine safety studies, including: 1) enrolling a substantial proportion of children with moderate-severe asthma 2) using digital peak flow meters and 3) collecting clinical data through multiple, complementary, measures for 42 days after vaccination. To capitalize on progress made during development of the study protocol and associated documents and procedures, CISA is proposing to carry out a study at the three sites to assess the feasibility of recruiting, enrolling, retaining, and collecting clinical data on children 5-11 years with persistent asthma of varied levels of severity in an influenza vaccine safety study. Findings from this proposed feasibility study will facilitate improving the LAIV4 study in the future if it goes forward through the CISA Project or in another venue. In 2016-2017 season, FDA approved a new influenza vaccine for use in persons aged 4 years and older, Flucelvax® Quadrivalent (ccIIV4); ACIP incorporated this vaccine into its recommendations for the 2016-2017 influenza season. Therefore ccIIV4 will be used in place of LAIV4 for this feasibility study. There is no evidence that Flucelvax® increases the risk of wheezing in asthmatic children. The feasibility study also offers an opportunity to gain some additional descriptive safety data for this new vaccine in asthmatic children.

Conditions: Asthmatic
Being tested: ccIIV4, IIV4
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ccIIV4Drug
Also called Flucelvax
IIV4Drug
Also called Fluarix

Study groups in NCT02967393
Study group	Role	What they receive
IIV4	Active comparator	0.5 mL intramuscular injection Receives: Drug: IIV4
cc IIV4	Active comparator	0.5 mL intramuscular injection Receives: Drug: ccIIV4

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility Benchmark: Number of Parents That Complete the Memory Aid 1.
Memory aid 1 is a diary completed by the subjects Parent. Daily symptoms, peak flow and requires the parent to record daily symptoms, peak flow, days, post-vaccination asthma clinical symptoms and symptom scores, adverse event, fever and concomitant medication administration data for 14 days (until day 15) after vaccination.
Measured: 15 days
Feasibility Benchmark: Number of Parent Completing Collection of Adverse Event Data
Parent will collect the following data: need for new prescription or nonprescription medications for the control of asthma, an unscheduled healthcare provider visit or consultation within 42 days after vaccination, any other clinically significant event occurring at any point during the study period. Serious Adverse Events (SAEs) will also be monitored through 42 days after vaccination and will include events that result in death, were life threatening, result in subject hospitalization or prolongation of existing hospitalization, result in persistent or significant disability or incapacity. Additionally, important medical events that may not have resulted in death, were not life threatening, or did not require hospitalization might be considered SAEs when, according to appropriate medical judgment, they jeopardize the patient or subject and require medical or surgical intervention to prevent one of the outcomes listed above.
Measured: Day 16 to 43
Feasibility Benchmark: Number of Parents That Perform and Document All Home Digital Peak Flow Measurements
Number of parents that perform and document all home digital peak flow measurements at least 11 days out of the 15-day monitoring period.
Measured: 15 days
Feasibility Benchmark: Number of Parents That Perform and Document the Digital Peak Flow for Day 42
Parent will perform and document the digital peak flow for Day 42
Measured: Day 42
Feasibility Benchmark: Number of Parents That Document Nighttime Awakenings
Number of parents that document nighttime awakenings for at least 11 of the 15-day monitoring period.
Measured: 15 days
Feasibility Benchmark: Number of Parents That Respond to Day 4 Call and Provide Requested Data
Number of parents that respond to Day 4 ( -1 day or + 2 days) call and provide requested data
Measured: Day 3 to 6
Feasibility Benchmark: Number of Parents That Respond to Day 8 Call and Provide Requested Data.
Number of parents that respond to Day 8 (plus 2 days) call and provide requested data.
Measured: Day 8-10
Feasibility Benchmark: Number of Parents That Respond to Day 15 Call and Provide Requested Data
Number of parents that respond to Day 15 (minus 1 or plus 2 days) call and provide requested data
Measured: Day 14 to 17
Feasibility Benchmark: Number of Parents That Respond to Day 29 Call and Provide Requested Data.
Number of Parents that respond to Day 29 ( Plus 2 Days) call and provide requested data.
Measured: Day 29-31
Feasibility Benchmark: Number of Parents That Respond to Day 44 Call
Number of parents that respond to Day 44 ( Plus 3 Days) call and provide requested data.
Measured: Day 44-47
Feasibility Benchmark: Number of Parents Completing a Satisfaction Survey
Parent of each participant will be asked to complete a at the end of the study
Measured: 42 days

Secondary outcomes (5)

Severe Local Reactogenicity Events During the 14 Days Post-vaccination
Number of severe local reactogenicity events for 14 days after vaccination between recipients of ccIIV4 and IIV4.
Measured: 14 days
Severe Systemic Reactogenicity Events During the 14 Days Post-vaccination
Number of solicited severe (not serious) systemic reactogenicity events for 14 days after vaccination between recipients of ccIIV4 and IIV4.
Measured: 14 days
Unsolicited and Severe Adverse Events
The nature and frequency of the unsolicited and Severe adverse events will be described in children receiving ccIIV4 and IIV4 during the 42 days after vaccination.
Measured: 42 days
Number of Asthma Exacerbations Requiring Steroids
For the purpose of this study, asthma exacerbation will be defined as: any acute episode of progressively worsening shortness of breath/dyspnea, cough, wheezing, chest tightness, and/or respiratory distress during the 42 days post-vaccination (until day 43) for which the patient receives a new prescription for systemic corticosteroids..
Measured: 42 days
Number Participants With Asthma Exacerbations Requiring Medical Attention
For the purpose of this study, asthma exacerbation will be defined as: any acute episode of progressively worsening shortness of breath/dyspnea, cough, wheezing, chest tightness, and/or respiratory distress during the 42 days post-vaccination (until day 43) for which the patient seeks unscheduled medical attention (e.g., healthcare provider office or Emergency Department visit or hospitalization)
Measured: 42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 20161 Feb 2017

First posted18 Nov 2016 (estimated)
Study start10 Oct 2016
Primary completion1 Feb 2017
Study completion1 Feb 2017

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.
Other trials for AsthmaticStudies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe 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 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02967393
Sponsor's protocol ID: IIV4/LAIV4/CDC
Status last verified: Mar 2018
First submitted: 31 Oct 2016
Last updated: 23 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility Study to Assess the Safety of Quadrivalent, Live Attenuated Influenza Vaccine (LAIV4) Versus Quadrivalent Inactivated Influenza Vaccine (IIV4) in Children Aged 5-11 Years With Persistent Asthma of Varied Severity (Cell Culture Quadrivalent IIV Used as Surrogate for LAIV4)
ClinicalTrials.gov ID: NCT02967393
Acronym / sponsor ID: IIV4/LAIV4/CDC
Conditions: Asthmatic
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Collaborators: Centers for Disease Control and Prevention, Duke University, Children's Hospital Medical Center, Cincinnati
Study start: 10 Oct 2016 (actual)
Primary completion: 1 Feb 2017 (actual)
Study completion: 1 Feb 2017 (actual)
First posted: 18 Nov 2016 (estimated)
Results: Posted 23 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The association of an increased risk in wheezing following receipt of a live-attenuated influenza vaccine in children at least 2 years of age with a prior history of asthma or wheeze remains unclear.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
IIV4	Active comparator	Drug: IIV40.5 mL intramuscular injection
cc IIV4	Active comparator	Drug: ccIIV40.5 mL intramuscular injection

Who may qualify

Ages: 5 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

Children between 5-11 years of age, inclusive, at enrollment.
Participant must have a current diagnosis of persistent asthma.
Parent/legal guardian must provide written informed consent and subject must provide assent as appropriate for age prior to initiation of study procedures and according to local Institutional Review Board (IRB) requirement.
Parent/legal guardian and subject must be willing and able to comply with planned study procedures and be available for all study visits.
Children aged 5-8 years must have received at least 2 doses of seasonal trivalent or quadrivalent influenza vaccine prior to the current influenza season. Children 9-11 years must have received at least 1 dose of seasonal trivalent or quadrivalent influenza vaccine prior to the current influenza season.

Key exclusion criteria (14 listed)

Acute illness and/or a reported oral temperature of ≥ 100.4°F within 72 hours prior to enrollment (this may result in a temporary delay of vaccination.
Use of antipyretic medication during the preceding 24 hours that might mask a fever (temporary deferral).
History of a severe allergic reaction (e.g., anaphylaxis) to any component of study influenza vaccines or a known allergy to eggs.
Receipt of any licensed vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to vaccination or planned receipt of any licensed vaccine within 42 days after vaccination.
Receipt of current year's licensed influenza vaccine.

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
ccIIV4Also: Flucelvax	Drug	cc IIV4
IIV4Also: Fluarix	Drug	IIV4

Primary outcome

Feasibility Benchmark: Number of Parents That Complete the Memory Aid 1.
Time frame: 15 days
Memory aid 1 is a diary completed by the subjects Parent. Daily symptoms, peak flow and requires the parent to record daily symptoms, peak flow, days, post-vaccination asthma clinical symptoms and symptom scores, adverse event, fever and concomitant medication administration data for 14 days (until day 15) after vaccination.
Feasibility Benchmark: Number of Parent Completing Collection of Adverse Event Data
Time frame: Day 16 to 43
Parent will collect the following data: need for new prescription or nonprescription medications for the control of asthma, an unscheduled healthcare provider visit or consultation within 42 days after vaccination, any other clinically significant event occurring at any point during the study period. Serious Adverse Events (SAEs) will also be monitored through 42 days after vaccination and will include events that result in death, were life threatening, result in subject hospitalization or prolongation of existing hospitalization, result in persistent or significant disability or incapacity. Additionally, important medical events that may not have resulted in death, were not life threatening, or did not require hospitalization might be considered SAEs when, according to appropriate medical judgment, they jeopardize the patient or subject and require medical or surgical intervention to prevent one of the outcomes listed above.
Feasibility Benchmark: Number of Parents That Perform and Document All Home Digital Peak Flow Measurements
Time frame: 15 days
Number of parents that perform and document all home digital peak flow measurements at least 11 days out of the 15-day monitoring period.
Feasibility Benchmark: Number of Parents That Perform and Document the Digital Peak Flow for Day 42
Time frame: Day 42
Parent will perform and document the digital peak flow for Day 42
Feasibility Benchmark: Number of Parents That Document Nighttime Awakenings
Time frame: 15 days
Number of parents that document nighttime awakenings for at least 11 of the 15-day monitoring period.
Feasibility Benchmark: Number of Parents That Respond to Day 4 Call and Provide Requested Data
Time frame: Day 3 to 6
Number of parents that respond to Day 4 ( -1 day or + 2 days) call and provide requested data
Feasibility Benchmark: Number of Parents That Respond to Day 8 Call and Provide Requested Data.
Time frame: Day 8-10
Number of parents that respond to Day 8 (plus 2 days) call and provide requested data.
Feasibility Benchmark: Number of Parents That Respond to Day 15 Call and Provide Requested Data
Time frame: Day 14 to 17
Number of parents that respond to Day 15 (minus 1 or plus 2 days) call and provide requested data
Feasibility Benchmark: Number of Parents That Respond to Day 29 Call and Provide Requested Data.
Time frame: Day 29-31
Number of Parents that respond to Day 29 ( Plus 2 Days) call and provide requested data.
Feasibility Benchmark: Number of Parents That Respond to Day 44 Call
Time frame: Day 44-47
Number of parents that respond to Day 44 ( Plus 3 Days) call and provide requested data.
Feasibility Benchmark: Number of Parents Completing a Satisfaction Survey
Time frame: 42 days
Parent of each participant will be asked to complete a at the end of the study

5 secondary outcomes

Severe Local Reactogenicity Events During the 14 Days Post-vaccination
Time frame: 14 days
Severe Systemic Reactogenicity Events During the 14 Days Post-vaccination
Time frame: 14 days
Unsolicited and Severe Adverse Events
Time frame: 42 days
Number of Asthma Exacerbations Requiring Steroids
Time frame: 42 days
Number Participants With Asthma Exacerbations Requiring Medical Attention
Time frame: 42 days

Results and safety

Results posted to the registry on 23 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ccIIV4	20	20
IIV4	20	20

Primary outcome: Feasibility Benchmark: Number of Parents That Complete the Memory Aid 1.

Time frame: 15 days. Count of participants. Unit: Participants

Measure	All Parents n = 40
Value	35

Population analysed: Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.

Primary outcome: Feasibility Benchmark: Number of Parent Completing Collection of Adverse Event Data

Time frame: Day 16 to 43. Count of participants. Unit: Participants

Measure	All Participants n = 40
Value	37

Primary outcome: Feasibility Benchmark: Number of Parents That Perform and Document All Home Digital Peak Flow Measurements

Time frame: 15 days. Count of participants. Unit: Participants

Measure	All Participants n = 40
Value	37

Primary outcome: Feasibility Benchmark: Number of Parents That Perform and Document the Digital Peak Flow for Day 42

Time frame: Day 42. Count of participants. Unit: Participants

Measure	All Participants n = 40
Value	37

Population analysed: Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received.. Feasibility Measure data will be reported as a single group.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 42 days from vaccination. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ccIIV4	1 of 20 (5%)	19 of 20 (95%)	0 of 20
IIV4	0 of 20 (0%)	19 of 20 (95%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Asthmatic

RecruitingPhase 1
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Asthma
RecruitingPhase 1
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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.

Kathryn M Edwards, MD principal investigator

Vanderbilt Vaccine Research Program

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ccIIV4 and IIV4 in people with Asthmatic, run by Vanderbilt University Medical Center at 4 sites 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 8 inclusion and 14 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 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2018). 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?

Feasibility Benchmark: Number of Parents That Complete the Memory Aid 1. (time frame: 15 days). The study lists 11 primary outcomes in all. 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 NCT02967393.

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 23 Apr 2018.