InfluenzaPhase 4SLVP016NCT03020472
Kinetics of B-Cell Responses to Live, Attenuated Influenza Vaccine (LAIV) in Young Children Two Years of Age
A Phase 4 study testing 2008-2009 FluMist LAIV (Intranasal) in people with Influenza, run by Stanford University at 1 site in United States.
Trial summary
This pilot study will investigate B-cell responses following vaccination with live, attenuated influenza vaccine (LAIV) in healthy children 2 years of age from blood samples taken at designated time points before and after vaccination. Read more about this study
- Who is it for?
- Ages 24 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- 2008-2009 FluMist LAIV (Intranasal)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jan 2009
- 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 24 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Otherwise healthy children, aged 24-35 months of age, inclusive.
- Parent(s) or guardian(s) willing to sign informed consent.
- Availability for follow-up for the planned duration of the study.
- Acceptable medical history by screening evaluation and brief clinical assessment.
- Able to understand and comply with planned study procedures
Who cannot join
- Prior vaccination with LAIV.
- TIV vaccination during two prior influenza vaccine seasons
- Known prior MD diagnosis of, or hospitalization for influenza
- History of asthma, active/recurrent wheezing or reactive airways disease
- History of immunodeficiency
- Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
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- Known underlying medical conditions (e.g. hemoglobinopathy, congestive heart failure) predisposing to influenza complications.
- Household contact with immunodeficiency due to disease, medication or radiation
- Child receiving aspirin therapy or aspirin-containing therapy
- History of Guillain-Barré syndrome
- Malignancy, other than squamous cell or basal cell skin cancer
- Autoimmune disease
- Use of immunosuppressive medication. Corticosteroid nasal sprays are permissible.
- Use of antiviral agents against Influenza A and/or B (such as Tamiflu, Relenza, Flumodine, Symmetrel) less than 48 hours before and/or less than two weeks after administration of FluMist.
- History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow-up or hospitalization during the preceding year.
- Use of investigational agents within 30 days prior to study
- Receipt of blood products or immunoglobulin in the past 6 months
- Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment
- Acute febrile illness on the day of vaccination
- Known allergies to any component of the vaccine, including eggs or egg products, gentamicin, gelatin,or arginine, or known life-threatening reactions to previous influenza vaccinations.
- Concurrent participation in other investigational protocols or receipt of an investigational product within the previous 30 days or planned receipt of an investigational product within 28 days following the last immunization dose.
- Any condition that, in the opinion of the investigator, might interfere with study objectives
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: U19 Year 6: Kinetics of B-Cell Responses to Live, Attenuated Influenza Vaccine (LAIV) in Young Children Two Years of Age, SLVP016
This pilot study will investigate B-cell responses following vaccination with live, attenuated influenza vaccine (LAIV) in healthy children 2 years of age from blood samples taken at designated time points before and after vaccination.
Read the detailed description
This is an exploratory study to determine the peripheral antibody secreting cell response during Days 5-13 after immunization with live, attenuated influenza vaccine (LAIV).
Investigators hoped to enroll 27 healthy children, 2 years of age who had not had any prior LAIV or trivalent inactivated vaccine (TIV) within the past 2 years. Due to low enrollment, the study was halted. Due to the limited number of samples, no analysis was performed.
- Conditions
- Influenza
- Being tested
- 2008-2009 FluMist LAIV (Intranasal)
- Keywords
- Live, attenuated influenza vaccine, Children
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2008-2009 FluMist LAIV (Intranasal)Biological
2008-2009 FluMist vaccine delivered intranasally
| Study group | Role | What they receive |
|---|---|---|
| 2008-2009 FluMist LAIV (Intranasal) | Experimental | 2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine Receives: Biological: 2008-2009 FluMist LAIV (Intranasal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Received Influenza Vaccine
Measured: Day 0 to Day 28
Secondary outcomes (1)
Number of Participants With Related Adverse Events
Measured: Day 0 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startNov 2008
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: Due to low enrollment
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 InfluenzaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Grant, Stanford University
- Investigators
- Harry B Greenberg, MD, Principal investigator, Stanford UniversityXiaosong He, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020472
- Sponsor's protocol ID
- SU-15086
- Other IDs
- U19AI057229
- Acronym
- SLVP016
- Status last verified
- Sep 2021
- First submitted
- 11 Jan 2017
- Last updated
- 18 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- U19 Year 6: Kinetics of B-Cell Responses to Live, Attenuated Influenza Vaccine (LAIV) in Young Children Two Years of Age, SLVP016
- ClinicalTrials.gov ID
- NCT03020472
- Acronym / sponsor ID
- SLVP016 / SU-15086
- Conditions
- Influenza
- Keywords
- Live, attenuated influenza vaccine, Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to low enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Nov 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Posted 3 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study will investigate B-cell responses following vaccination with live, attenuated influenza vaccine (LAIV) in healthy children 2 years of age from blood samples taken at designated time points before and after vaccination.
Detailed description
This is an exploratory study to determine the peripheral antibody secreting cell response during Days 5-13 after immunization with live, attenuated influenza vaccine (LAIV).
Investigators hoped to enroll 27 healthy children, 2 years of age who had not had any prior LAIV or trivalent inactivated vaccine (TIV) within the past 2 years. Due to low enrollment, the study was halted. Due to the limited number of samples, no analysis was performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2008-2009 FluMist LAIV (Intranasal) | Experimental | Biological: 2008-2009 FluMist LAIV (Intranasal)2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine |
Who may qualify
- Ages
- 24 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Otherwise healthy children, aged 24-35 months of age, inclusive.
- Parent(s) or guardian(s) willing to sign informed consent.
- Availability for follow-up for the planned duration of the study.
- Acceptable medical history by screening evaluation and brief clinical assessment.
- Able to understand and comply with planned study procedures
Key exclusion criteria (22 listed)
- Prior vaccination with LAIV.
- TIV vaccination during two prior influenza vaccine seasons
- Known prior MD diagnosis of, or hospitalization for influenza
- History of asthma, active/recurrent wheezing or reactive airways disease
- History of immunodeficiency
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 |
|---|---|---|
| 2008-2009 FluMist LAIV (Intranasal)2008-2009 FluMist vaccine delivered intranasally | Biological | 2008-2009 FluMist LAIV (Intranasal) |
Primary outcome
Number of Participants Who Received Influenza Vaccine
Time frame: Day 0 to Day 28
1 secondary outcome
Number of Participants With Related Adverse Events
Time frame: Day 0 to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Harry B Greenberg, MD principal investigator
Stanford University
Xiaosong He, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2008-2009 FluMist LAIV (Intranasal) in people with Influenza, run by Stanford University at 1 site 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 5 inclusion and 22 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: stopped early, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 Mar 2017). 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?
Number of Participants Who Received Influenza Vaccine (time frame: Day 0 to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2021.