InfluenzaPhase 4NCT03023176
T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 5, 2013
A Phase 4 study testing Fluzone® standard IIV3 and Fluzone® standard IIV3 Pediatric Dose in people with Influenza, run by Stanford University.
Trial summary
This study will investigate markers, mechanisms and define general predictors for immunological health by comparing influenza vaccine responses in monozygotic and dizygotic twins. Read more about this study
- Who is it for?
- Ages 1 year to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Fluzone® standard IIV3 and Fluzone® standard IIV3 Pediatric Dose
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Nov 2013
- 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 1 year to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Otherwise healthy, twin children age 1-8 years (identical or fraternal twin pairs)
- Parent willing to sign the informed consent form and child willing to sign assent if indicated.
- Availability for follow-up for the planned duration of the study at least 28 days after last immunization.
- Acceptable relevant medical history and vital signs.
Who cannot join
- Prior off-study vaccination with trivalent inactivated influenza vaccine (IIV3) or live attenuated influenza vaccine (LAIV) in Fall 2013
- Allergy to egg or egg products, or to vaccine components or thimerosal (if IIV3 multidose vials used)
- Life-threatening reactions to previous influenza vaccinations
- Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
- History of immunodeficiency (including HIV infection)
- Known or suspected impairment of immunologic function, including, but not limited to, clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
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- Chronic Hepatitis B or C
- Recent or current use of immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays, topical steroids are permissible). History of any cancer.
- Autoimmune disease including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
- History of blood dyscrasias, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
- Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin.
- Receipt of blood or blood products within the past 6 months or planned receipt of blood products prior to completion of study visits.
- Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
- Receipt of inactivated vaccine 14 days prior to enrollment, or planned non-study vaccination prior to completion of Visit 03 or 04 (~Day 28 after the last study vaccination)
- Receipt of a live, attenuated vaccine within 30 days prior to first vaccination, or planned immunization with a live, attenuated vaccine before completion of study visits (inform study staff of any non-study vaccinations received during the study period).
- Need for allergy immunization (that cannot be postponed) during the study period.
- History of Guillain-Barre Syndrome
- Use of investigational agents within 30 days prior to enrollment or planned use of investigational agents prior to completion of study visits.
- Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.
About this study
Official title: Protective Mechanisms Against a Pandemic Respiratory Virus: B-cell, T-cell, and General Immune Response to Seasonal Influenza Vaccine. Year 5, 2013
This study will investigate markers, mechanisms and define general predictors for immunological health by comparing influenza vaccine responses in monozygotic and dizygotic twins.
Read the detailed description
The investigators plan to study the immune response to different influenza vaccines much more broadly and deeply across different age groups and with different vaccine modalities and to probe the influence of genetics on these responses using monozygotic and dizygotic twins. The investigators plan to compare various immunological responses, identify age-specific biomarkers or clusters of markers, quantify the frequency of influenza-specific T-cells pre- and post-vaccination, and determine the effective breadth of T-cell repertoire to an influenza vaccine within an individual as a function of age and to what degree this is genetically determined.
The study will be conducted in healthy young identical and fraternal 1-8 year-old twins. All participants will be immunized with seasonal trivalent inactivated influenza vaccine (IIV3). Blood samples to conduct the assays described will be taken at pre-immunization, Days 6-8 and 28 post-immunization for children requiring 1 dose of vaccine. For children requiring 2 doses of vaccine, a second immunization will be given at least 28 days after Dose 1 with responses measured on Day 6-8 and Day 28-32 post-second immunization.
Children 35 months and under will receive Fluzone® standard IIV3 Pediatric Dose, while children 36 months and older will receive Fluzone® standard IIV3.
- Conditions
- Influenza
- Being tested
- Fluzone® standard IIV3, Fluzone® standard IIV3 Pediatric Dose
- Keywords
- Trivalent, inactivated influenza vaccine, Child identical twins, Child fraternal twins
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluzone® standard IIV3Biological
Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection
Fluzone® standard IIV3 Pediatric DoseBiological
Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection
| Study group | Role | What they receive |
|---|---|---|
| Healthy 1-8 year-old twins | Other | Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care. Receives: Biological: Fluzone® standard IIV3; Biological: Fluzone® standard IIV3 Pediatric Dose |
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 32
Secondary outcomes (1)
Number of Participants With Related Adverse Events
Measured: Day 0 to 32 post-immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startSep 2013
- Primary completionNov 2013
- Study completionNov 2013
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 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cornelia L. Dekker, Stanford University
- Investigators
- Cornelia Dekker, MD, Principal investigator, Stanford UniversityMark Davis, PhD, Principal investigator, Stanford UniversityGarry Nolan, PhD, Principal investigator, Stanford UniversityAnn Arvin, MD, Principal investigator, Stanford UniversityStephen Quake, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023176
- Sponsor's protocol ID
- SU-17219-2013
- Other IDs
- 2U19AI057229-06
- Status last verified
- Apr 2017
- First submitted
- 13 Jan 2017
- Last updated
- 21 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Le Gars M, Kay AW, Bayless NL, Aziz N, Dekker CL, Swan GE, Davis MM, Blish CA. Increased Proinflammatory Responses of Monocytes and Plasmacytoid Dendritic Cells to Influenza A Virus Infection During Pregnancy. J Infect Dis. 2016 Dec 1;214(11):1666-1671. doi: 10.1093/infdis/jiw448. Epub 2016 Sep 21.
PubMed 27655870
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Mechanisms Against a Pandemic Respiratory Virus: B-cell, T-cell, and General Immune Response to Seasonal Influenza Vaccine. Year 5, 2013
- ClinicalTrials.gov ID
- NCT03023176
- Acronym / sponsor ID
- SU-17219-2013
- Conditions
- Influenza
- Keywords
- Trivalent, inactivated influenza vaccine, Child identical twins, Child fraternal twins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Sep 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Posted 9 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 study will investigate markers, mechanisms and define general predictors for immunological health by comparing influenza vaccine responses in monozygotic and dizygotic twins.
Detailed description
The investigators plan to study the immune response to different influenza vaccines much more broadly and deeply across different age groups and with different vaccine modalities and to probe the influence of genetics on these responses using monozygotic and dizygotic twins. The investigators plan to compare various immunological responses, identify age-specific biomarkers or clusters of markers, quantify the frequency of influenza-specific T-cells pre- and post-vaccination, and determine the effective breadth of T-cell repertoire to an influenza vaccine within an individual as a function of age and to what degree this is genetically determined.
The study will be conducted in healthy young identical and fraternal 1-8 year-old twins. All participants will be immunized with seasonal trivalent inactivated influenza vaccine (IIV3). Blood samples to conduct the assays described will be taken at pre-immunization, Days 6-8 and 28 post-immunization for children requiring 1 dose of vaccine. For children requiring 2 doses of vaccine, a second immunization will be given at least 28 days after Dose 1 with responses measured on Day 6-8 and Day 28-32 post-second immunization.
Children 35 months and under will receive Fluzone® standard IIV3 Pediatric Dose, while children 36 months and older will receive Fluzone® standard IIV3.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy 1-8 year-old twins | Other | Biological: Fluzone® standard IIV3, Biological: Fluzone® standard IIV3 Pediatric DoseHealthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care. |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Otherwise healthy, twin children age 1-8 years (identical or fraternal twin pairs)
- Parent willing to sign the informed consent form and child willing to sign assent if indicated.
- Availability for follow-up for the planned duration of the study at least 28 days after last immunization.
- Acceptable relevant medical history and vital signs.
Key exclusion criteria (19 listed)
- Prior off-study vaccination with trivalent inactivated influenza vaccine (IIV3) or live attenuated influenza vaccine (LAIV) in Fall 2013
- Allergy to egg or egg products, or to vaccine components or thimerosal (if IIV3 multidose vials used)
- Life-threatening reactions to previous influenza vaccinations
- Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
- History of immunodeficiency (including HIV infection)
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 |
|---|---|---|
| Fluzone® standard IIV3Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection | Biological | Healthy 1-8 year-old twins |
| Fluzone® standard IIV3 Pediatric DoseInfluenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection | Biological | Healthy 1-8 year-old twins |
Primary outcome
Number of Participants Who Received Influenza Vaccine
Time frame: Day 0 to 32
1 secondary outcome
Number of Participants With Related Adverse Events
Time frame: Day 0 to 32 post-immunization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27655870Le Gars M, Kay AW, Bayless NL, Aziz N, Dekker CL, Swan GE, Davis MM, Blish CA. Increased Proinflammatory Responses of Monocytes and Plasmacytoid Dendritic Cells to Influenza A Virus Infection During Pregnancy. J Infect Dis. 2016 Dec 1;214(11):1666-1671. doi: 10.1093/infdis/jiw448. Epub 2016 Sep 21.
- 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.
Cornelia Dekker, MD principal investigator
Stanford University
Mark Davis, PhD principal investigator
Stanford University
Garry Nolan, PhD principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluzone® standard IIV3 and Fluzone® standard IIV3 Pediatric Dose in people with Influenza, run by Stanford University.
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 4 inclusion and 19 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 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 9 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 32). 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 NCT03023176, 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 21 Apr 2017.