Influenza Vaccine Feasibility Study in Children With Pers... | NCT02967393

NCT02967393

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Centers for Disease Control and Prevention	FED
Duke University	OTHER
Children's Hospital Medical Center, Cincinnati	OTHER

Description Module

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.

Label	Type	Description	Intervention Names
IIV4	Active Comparator	0.5 mL intramuscular injection	Drug: IIV4
cc IIV4	Active Comparator	0.5 mL intramuscular injection	Drug: ccIIV4

Name	Type	Description	Arm Group Labels	Other Names
ccIIV4	Drug		cc IIV4	Flucelvax
IIV4

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	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.	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	Day 42

Secondary Outcomes

Measure	Description	Time Frame
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.	14 days
Severe Systemic Reactogenicity Events During the 14 Days Post-vaccination

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Name	Affiliation	Role
Kathryn M Edwards, MD	Vanderbilt Vaccine Research Program	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Centers for Disease Control and Prevention		Atlanta	Georgia	30329	United States
Duke Clinical Vaccine Unit

ID	Title	Description
FG000	ccIIV4	0.5 mL intramuscular injection ccIIV4
FG001	IIV4	0.5 mL intramuscular injection IIV4

Baseline Characteristics Module

ID	Title	Description
BG000	ccIIV4	0.5 mL intramuscular injection ccIIV4
BG001	IIV4	0.5 mL intramuscular injection IIV4

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

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.

Posted

Count of Participants

Participants

15 days

ID	Title	Description
OG000	All Parents	Parents of participants from both arms

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ccIIV4	0.5 mL intramuscular injection ccIIV4	0

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

ID	Term
D007252	Influenza Vaccines
C510903	fluarix

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures