Asthma in ChildrenPhase 4NCT03600428
Safety of LAIV4 in Children With Asthma
A Phase 4 study testing Live Attenuated Influenza Vaccine (LAIV) and Inactivated Influenza Vaccine (IIV) in people with Asthma in Children and Vaccine Adverse Reaction, run by Vanderbilt University Medical Center at 3 sites in United States.
Trial summary
This is a prospective randomized, open label clinical trial in approximately 300 children aged 5-11 years with a physician diagnosis of persistent asthma. Participants will be randomized 1:1 to receive either a single intranasal dose of licensed quadrivalent LAIV (LAIV4) or an intramuscular injection of quadrivalent… Read more about this study
- Who is it for?
- Ages 5 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children, Vaccine Adverse Reaction, Vaccine Reaction
- What is being tested?
- Live Attenuated Influenza Vaccine (LAIV) and Inactivated Influenza Vaccine (IIV)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Oct 2018to 20 Mar 2020
- 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
- Healthy volunteers accepted
- 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 (Physician diagnosis of asthma and current prescribed use of a long-acting controller medication. For purposes of this study, we have considered "controller" medications to be any single or combination use of long-acting medications used to prevent asthma exacerbations and to achieve long-term control of asthma (as compared to short-acting rescue medication).)
- Parent(s) or legal guardian(s) must provide written, informed consent and participant must provide assent as appropriate for age prior to initiation of study procedures and according to local IRB requirements
- Parent(s) or legal guardian(s) and participant must be willing and able to comply with planned study procedures and be available for all study visits
- Is in good health, other than their asthma, as determined by medical history
- English or Spanish literate (only English-speaking participants will be included at the Cincinnati and Duke sites)
- Intention of being available for entire study period and complete all relevant study procedures, including follow-up using at least one of the following methods: phone calls, text messages, or emails
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 (this may result in a temporary delay of vaccination)
- History of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any influenza vaccine or after any component of the influenza vaccine, including egg protein.
- 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 (2018-2019 influenza season) licensed influenza vaccine for children 9-11 years (only). (Clarification: Children aged 5-8 years are permitted to be enrolled if they have received zero or one dose of the 2018-2019 influenza season vaccine, and require two doses of the 2018-2019 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 16Show fewer
- Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months
- Have taken ≥20mg/day of prednisone or its equivalent, for 14 days or more within the past 28 days
- Have known 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)
- Received influenza antiviral medication within 48 hours prior to study vaccination
- History of Guillian-Barré syndrome within 6 weeks of previous influenza vaccination
- Have 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 a positive urine or serum pregnancy test within 24 hours prior to vaccination in a post-menarchal female. LAIV is not recommended for use in pregnant females.
- Currently taking aspirin or aspirin-containing products
- Any parent(s) or legal guardian(s) who is an immediate relative of study staff or is an employee supervised by study staff.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Duke University Medical Center
Durham, North Carolina, 27710
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Clinical Study of the Safety of Quadrivalent Live Attenuated Influenza Vaccine (LAIV4) in Children With Asthma of Varying Levels of Severity
This is a prospective randomized, open label clinical trial in approximately 300 children aged 5-11 years with a physician diagnosis of persistent asthma. Participants will be randomized 1:1 to receive either a single intranasal dose of licensed quadrivalent LAIV (LAIV4) or an intramuscular injection of quadrivalent IIV4 (IIV4).
Read the detailed description
The study will be conducted at three sites: Vanderbilt University Medical Center (Lead site), Cincinnati Children's Hospital Medical Center (contributing site), and Duke University Medical Center (contributing site) during the 2018-2019 influenza season. Participants will be randomized 1:1 to receive either a single intranasal dose of licensed quadrivalent LAIV (LAIV4) or an intramuscular injection of quadrivalent IIV4 (IIV4), stratifying by asthma severity (mild vs. moderate-to-severe). Vanderbilt will enroll about 100 participants, Cincinnati will enroll about 110 participants, and Duke will enroll about 90 participants. After enrollment, participants will be followed for 43 days via 5 additional phone, email, or text visits to monitor systemic reactogenicity, asthma symptoms and exacerbations, and serious adverse events. The primary objective is to compare proportions of participants with asthma exacerbations during the 42 days after LAIV4 versus IIV4. Because of the potential for increased risk of wheezing after LAIV, the use of LAIV in persons with asthma has been an area of vaccine safety research for many years; the safety issue remains unresolved. A clinical study to assess the safety of LAIV4 in children with asthma could expand the evidence base and inform clinical decision-making and public health policy.
- Conditions
- Asthma in Children, Vaccine Adverse Reaction, Vaccine Reaction, Asthma, Wheezing, Influenza
- Being tested
- Live Attenuated Influenza Vaccine (LAIV), Inactivated Influenza Vaccine (IIV)
- Keywords
- asthma, influenza vaccine, inactivated influenza vaccine, live attenuated influenza vaccine
- Medical subject headings
- Asthma, Respiratory Sounds, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Attenuated Influenza Vaccine (LAIV)Biological
1 dose, 0.2 mL, intranasal administration
Inactivated Influenza Vaccine (IIV)Biological
1 dose, 0.5 mL, intramuscular administration
| Study group | Role | What they receive |
|---|---|---|
| Live Attenuated Influenza Vaccine (LAIV) | Experimental | Participants will receive one dose of live attenuated influenza vaccine via intranasal spray (administer approximately one half of the contents of the single-dose intranasal sprayer into each nostril, each sprayer contains 0.2 mL of vaccine)). Receives: Biological: Live Attenuated Influenza Vaccine (LAIV) |
| Inactivated Influenza Vaccine (IIV) | Active comparator | Participants will receive one dose of inactivated influenza vaccine via intramuscular injection (0.5 mL). Receives: Biological: Inactivated Influenza Vaccine (IIV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the Proportion of Participants Experiencing an Asthma Exacerbation During the 42 Days After LAIV4 vs. IIV4 (Until Day 43).
For 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 (until day 43) after influenza vaccination for which the patient seeks unscheduled medical attention (e.g., healthcare provider office or Emergency Department visit or hospitalization) or receives a new prescription for systemic corticosteroids.
Measured: Day 43
Secondary outcomes (3)
Comparison of the Proportion of Participants Experiencing an Asthma Exacerbation During the 14 Days After LAIV4 vs. IIV4
For 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 14 days (until day 15) after influenza vaccination for which the patient seeks unscheduled medical attention (e.g., healthcare provider office or Emergency Department visit or hospitalization) or receives a new prescription for systemic corticosteroids.
Measured: Day 15
Comparison of the Proportion of Participants With Asthma Symptoms and Unscheduled Albuterol Use During the 14 Days After Receipt of LAIV4 or IIV4 (Each is Assessed Separately).
Cough, wheezing, tightness in chest, nighttime awakening and unscheduled albuterol use will all be assessed by parent self-report
Measured: Day 15
Comparison of the Proportion of Participants Who Experience a Clinically Significant Decrease in Peak Flow Measurement From Baseline During the 14 Days After LAIV4 or IIV4
For purposes of this measure, a clinically significant decrease in peak flow is defined as: a decrease of ≥20% in PEFR from baseline PEFR
Measured: Baseline, Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start15 Oct 2018
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
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 Asthma in ChildrenStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Duke University, Children's Hospital Medical Center, Cincinnati
- Responsible party
- Principal investigator, Buddy Creech, Vanderbilt University Medical Center
- Investigators
- Buddy Creech, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600428
- Sponsor's protocol ID
- 181211
- Other IDs
- 200-2012-50430 Task Order 0005
- Status last verified
- Feb 2021
- First submitted
- 11 Jul 2018
- Last updated
- 16 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sokolow AG, Stallings AP, Kercsmar C, Harrington T, Jimenez-Truque N, Zhu Y, Sokolow K, Moody MA, Schlaudecker EP, Walter EB, Staat MA, Broder KR, Creech CB. Safety of Live Attenuated Influenza Vaccine in Children With Asthma. Pediatrics. 2022 Apr 1;149(4):e2021055432. doi: 10.1542/peds.2021-055432.
PubMed 35342923
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Safety of Quadrivalent Live Attenuated Influenza Vaccine (LAIV4) in Children With Asthma of Varying Levels of Severity
- ClinicalTrials.gov ID
- NCT03600428
- Acronym / sponsor ID
- 181211
- Conditions
- Asthma in Children, Vaccine Adverse Reaction, Vaccine Reaction, Asthma, Wheezing, Influenza
- Keywords
- asthma, influenza vaccine, inactivated influenza vaccine, live attenuated influenza vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 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
- 15 Oct 2018 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 25 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective randomized, open label clinical trial in approximately 300 children aged 5-11 years with a physician diagnosis of persistent asthma. Participants will be randomized 1:1 to receive either a single intranasal dose of licensed quadrivalent LAIV (LAIV4) or an intramuscular injection of quadrivalent IIV4 (IIV4).
Detailed description
The study will be conducted at three sites: Vanderbilt University Medical Center (Lead site), Cincinnati Children's Hospital Medical Center (contributing site), and Duke University Medical Center (contributing site) during the 2018-2019 influenza season. Participants will be randomized 1:1 to receive either a single intranasal dose of licensed quadrivalent LAIV (LAIV4) or an intramuscular injection of quadrivalent IIV4 (IIV4), stratifying by asthma severity (mild vs. moderate-to-severe). Vanderbilt will enroll about 100 participants, Cincinnati will enroll about 110 participants, and Duke will enroll about 90 participants. After enrollment, participants will be followed for 43 days via 5 additional phone, email, or text visits to monitor systemic reactogenicity, asthma symptoms and exacerbations, and serious adverse events. The primary objective is to compare proportions of participants with asthma exacerbations during the 42 days after LAIV4 versus IIV4. Because of the potential for increased risk of wheezing after LAIV, the use of LAIV in persons with asthma has been an area of vaccine safety research for many years; the safety issue remains unresolved. A clinical study to assess the safety of LAIV4 in children with asthma could expand the evidence base and inform clinical decision-making and public health policy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Live Attenuated Influenza Vaccine (LAIV) | Experimental | Biological: Live Attenuated Influenza Vaccine (LAIV)Participants will receive one dose of live attenuated influenza vaccine via intranasal spray (administer approximately one half of the contents of the single-dose intranasal sprayer into each nostril, each sprayer contains 0.2 mL of vaccine)). |
| Inactivated Influenza Vaccine (IIV) | Active comparator | Biological: Inactivated Influenza Vaccine (IIV)Participants will receive one dose of inactivated influenza vaccine via intramuscular injection (0.5 mL). |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children between 5-11 years of age, inclusive, at enrollment
- Participant must have a current diagnosis of persistent asthma (Physician diagnosis of asthma and current prescribed use of a long-acting controller medication. For purposes of this study, we have considered "controller" medications to be any single or combination use of long-acting medications used to prevent asthma exacerbations and to achieve long-term control of asthma (as compared to short-acting rescue medication).)
- Parent(s) or legal guardian(s) must provide written, informed consent and participant must provide assent as appropriate for age prior to initiation of study procedures and according to local IRB requirements
- Parent(s) or legal guardian(s) and participant must be willing and able to comply with planned study procedures and be available for all study visits
- Is in good health, other than their asthma, as determined by medical history
Key exclusion criteria (16 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 (this may result in a temporary delay of vaccination)
- History of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any influenza vaccine or after any component of the influenza vaccine, including egg protein.
- 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 (2018-2019 influenza season) licensed influenza vaccine for children 9-11 years (only). (Clarification: Children aged 5-8 years are permitted to be enrolled if they have received zero or one dose of the 2018-2019 influenza season vaccine, and require two doses of the 2018-2019 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 |
|---|---|---|
| Live Attenuated Influenza Vaccine (LAIV)1 dose, 0.2 mL, intranasal administration | Biological | Live Attenuated Influenza Vaccine (LAIV) |
| Inactivated Influenza Vaccine (IIV)1 dose, 0.5 mL, intramuscular administration | Biological | Inactivated Influenza Vaccine (IIV) |
Primary outcome
Comparison of the Proportion of Participants Experiencing an Asthma Exacerbation During the 42 Days After LAIV4 vs. IIV4 (Until Day 43).
Time frame: Day 43
For 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 (until day 43) after influenza vaccination for which the patient seeks unscheduled medical attention (e.g., healthcare provider office or Emergency Department visit or hospitalization) or receives a new prescription for systemic corticosteroids.
3 secondary outcomes
Comparison of the Proportion of Participants Experiencing an Asthma Exacerbation During the 14 Days After LAIV4 vs. IIV4
Time frame: Day 15
Comparison of the Proportion of Participants With Asthma Symptoms and Unscheduled Albuterol Use During the 14 Days After Receipt of LAIV4 or IIV4 (Each is Assessed Separately).
Time frame: Day 15
Comparison of the Proportion of Participants Who Experience a Clinically Significant Decrease in Peak Flow Measurement From Baseline During the 14 Days After LAIV4 or IIV4
Time frame: Baseline, Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35342923Sokolow AG, Stallings AP, Kercsmar C, Harrington T, Jimenez-Truque N, Zhu Y, Sokolow K, Moody MA, Schlaudecker EP, Walter EB, Staat MA, Broder KR, Creech CB. Safety of Live Attenuated Influenza Vaccine in Children With Asthma. Pediatrics. 2022 Apr 1;149(4):e2021055432. doi: 10.1542/peds.2021-055432.
- Individual participant dataSharing planned: No
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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.
Buddy Creech, MD, MPH principal investigator
Vanderbilt University Medical Center
3 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 Live Attenuated Influenza Vaccine (LAIV) and Inactivated Influenza Vaccine (IIV) in people with Asthma in Children and Vaccine Adverse Reaction, run by Vanderbilt University Medical Center at 3 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 7 inclusion and 16 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 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 25 Feb 2021). 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?
Comparison of the Proportion of Participants Experiencing an Asthma Exacerbation During the 42 Days After LAIV4 vs. IIV4 (Until Day 43). (time frame: Day 43). 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 NCT03600428, 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 16 Mar 2021.