InfluenzaPhase 4SNIFNCT01933048
Self-Administered Nasal Influenza Feasibility Study
A Phase 4 study testing FluMist in people with Influenza, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 2 sites in United States.
Trial summary
The purpose of this prospective, open-label clinical trial is to evaluate the immunogenicity of self-administered (SA) live, attenuated influenza vaccine (LAIV) in comparison with healthcare worker administered (HCWA) LAIV and to evaluate the feasibility of group self-administration of LAIV. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- FluMist
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,077 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2012to Oct 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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or healthy, non-pregnant females
- 18-49 years of age
- Department of Defense beneficiary including active duty members
- Able to speak and understand English, and provide written informed consent
Who cannot join
- Known hypersensitivity to eggs, egg-proteins, gentamicin, gelatin, or arginine or life-threatening reactions to previous influenza vaccination
- Prior receipt of the 2012-2013 seasonal influenza vaccine for 2012-2013 season or prior receipt of the 2013-2014 seasonal influenza vaccine for 2013-2014 season
- Known clinical diagnosis of reactive airway disease, wheezing, or asthma (excluding exercise-induced asthma)
- Reported febrile upper respiratory illness (oral or tympanic temperature greater than 100°F or a subjective fever) at the time of or within the 24 hours prior to immunization
- Known to be pregnant, possibly pregnant or breast-feeding
- Known diagnosis of human immunodeficiency virus (HIV) infection, chronic active hepatitis B infection, or chronic hepatitis C infection
Show all 14Show fewer
- History of Guillain-Barre Syndrome
- Household member known to be immunocompromised (either a known disease or disorder such as HIV, or other acquired or congenital immunodeficiency disorder, or taking systemic steroids (any dose) or high daily dose inhaled steroids, tumor necrosis factor-alpha inhibitors, or monoclonal antibodies used to treat autoimmune disease)
- Receipt of medications with activity against influenza A and/or B (ex: Tamiflu®, Relenza®, amantadine, or rimantadine) within 48 hours prior to vaccine administration
- Use of any oral or intravenous systemic steroids (any dose) or any daily dose inhaled steroids
- At the time of enrollment, any person who is trained to administer intranasal vaccines or who has been involved in any recurring role associated with the administration of intranasal vaccines to others in the clinic or military treatment facility (MTF)
- Prior participation in this research study
- Any acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe, interfere with the evaluation of responses, or render the subject unable to meet the requirements of the protocol. These conditions may include, but are not limited to: history of significant renal impairment (dialysis and treatment for kidney disease, including diabetic and hypertensive kidney disease); poorly controlled diabetes mellitus or patients with diabetes mellitus on insulin (subjects with well-controlled diabetes mellitus on oral agents may enroll as long there has been no dosage increase within the past 6 months); cardiac insufficiency, if heart failure is present; an arteriosclerotic event during the 6 months prior to enrollment (e.g., history of myocardial infarction, stroke, recanalization of femoral arteries, or transient ischemic attack).
- If the individual received a live virus vaccine (e.g., Varicella, Measles-Mumps-Rubella, Yellow Fever, Smallpox) in the past 4 weeks, they should wait 28 days before receiving LAIV. There is no reason to defer vaccination if the individual was vaccinated with an inactivated vaccine or if they have recently received blood or other antibody-containing blood products.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
San Antonio Military Health System
Fort Sam Houston, Texas, 78234
Naval Medical Center San Diego
San Diego, California, 92134
About this study
Official title: Self-Administered Nasal Influenza Vaccine: Immunogenicity and Feasibility of Group Administration
The purpose of this prospective, open-label clinical trial is to evaluate the immunogenicity of self-administered (SA) live, attenuated influenza vaccine (LAIV) in comparison with healthcare worker administered (HCWA) LAIV and to evaluate the feasibility of group self-administration of LAIV.
Read the detailed description
This Phase IV, open-label, prospective clinical trial assesses SA-LAIV, testing whether the immunogenicity of SA-LAIV is non-inferior to that of HCWA-LAIV, as well as evaluating the feasibility of utilizing group administration for SA-LAIV. Subjects will be enrolled into one of two major treatment arms: HCWA-LAIV (Estimated N = 550) and SA-LAIV (Estimated N = 550). Enrollment into each major treatment arm will be stratified by study site. Enrollment in the HCWA-LAIV and SA-LAIV treatment arms may occur concurrently at each site. Subjects enrolling in the study will be randomized to HCWA or SA, and within the SA arm to either individual self-administration, or group administration. Specifically, following self-administration of LAIV to 190 individual subjects, 180 subjects will be vaccinated in 36 groups of 5 and 180 subjects will be vaccinated in 18 groups of 10. All vaccinations in the SA-LAIV arm will be given under the direction and supervision of a research staff member who is trained to administer LAIV vaccines. Following immunization all subjects will return for one visit at approximately 28 (± 7) days for follow-up.
- Conditions
- Influenza
- Being tested
- FluMist
- Keywords
- influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluMistDrug
Also called influenza virus vaccine LAIV4
FluMist Intranasal Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Healthcare Worker Administration | Other | FluMist administered by a Healthcare Worker Receives: Drug: FluMist |
| Self-Administration | Experimental | FluMist self-administered by subject Receives: Drug: FluMist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-vaccination Geometric Mean Titer (GMT) Ratios Between HCWA and SA Subjects
Measured: 28+/- 7 days post-vaccination
Secondary outcomes (2)
Difference and Proportion in Seroresponse of Subjects
Measured: 28+/- 7 days post-vaccination
Difference and Proportion in Seroconversion of Subjects
Measured: 28+/- 7 days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startSep 2012
- Primary completionOct 2013
- Study completionOct 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.
- 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
- 1,077 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy Burgess, MD, MPH, Study director, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933048
- Sponsor's protocol ID
- IDCRP-070
- Acronym
- SNIF
- Status last verified
- Feb 2023
- First submitted
- 8 Aug 2013
- Last updated
- 15 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Sharing of individual participant data (IPD) would require revisions and additional regulatory approval, that will not be pursued.
Publications
Burgess TH, Murray CK, Bavaro MF, Landrum ML, O'Bryan TA, Rosas JG, Cammarata SM, Martin NJ, Ewing D, Raviprakash K, Mor D, Zell ER, Wilkins KJ, Millar EV. Self-administration of intranasal influenza vaccine: Immunogenicity and volunteer acceptance. Vaccine. 2015 Jul 31;33(32):3894-9. doi: 10.1016/j.vaccine.2015.06.061. Epub 2015 Jun 25.
PubMed 26117150
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Administered Nasal Influenza Vaccine: Immunogenicity and Feasibility of Group Administration
- ClinicalTrials.gov ID
- NCT01933048
- Acronym / sponsor ID
- SNIF / IDCRP-070
- Conditions
- Influenza
- Keywords
- influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,077 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Posted 12 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this prospective, open-label clinical trial is to evaluate the immunogenicity of self-administered (SA) live, attenuated influenza vaccine (LAIV) in comparison with healthcare worker administered (HCWA) LAIV and to evaluate the feasibility of group self-administration of LAIV.
Detailed description
This Phase IV, open-label, prospective clinical trial assesses SA-LAIV, testing whether the immunogenicity of SA-LAIV is non-inferior to that of HCWA-LAIV, as well as evaluating the feasibility of utilizing group administration for SA-LAIV. Subjects will be enrolled into one of two major treatment arms: HCWA-LAIV (Estimated N = 550) and SA-LAIV (Estimated N = 550). Enrollment into each major treatment arm will be stratified by study site. Enrollment in the HCWA-LAIV and SA-LAIV treatment arms may occur concurrently at each site. Subjects enrolling in the study will be randomized to HCWA or SA, and within the SA arm to either individual self-administration, or group administration. Specifically, following self-administration of LAIV to 190 individual subjects, 180 subjects will be vaccinated in 36 groups of 5 and 180 subjects will be vaccinated in 18 groups of 10. All vaccinations in the SA-LAIV arm will be given under the direction and supervision of a research staff member who is trained to administer LAIV vaccines. Following immunization all subjects will return for one visit at approximately 28 (± 7) days for follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthcare Worker Administration | Other | Drug: FluMistFluMist administered by a Healthcare Worker |
| Self-Administration | Experimental | Drug: FluMistFluMist self-administered by subject |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males or healthy, non-pregnant females
- 18-49 years of age
- Department of Defense beneficiary including active duty members
- Able to speak and understand English, and provide written informed consent
Key exclusion criteria (14 listed)
- Known hypersensitivity to eggs, egg-proteins, gentamicin, gelatin, or arginine or life-threatening reactions to previous influenza vaccination
- Prior receipt of the 2012-2013 seasonal influenza vaccine for 2012-2013 season or prior receipt of the 2013-2014 seasonal influenza vaccine for 2013-2014 season
- Known clinical diagnosis of reactive airway disease, wheezing, or asthma (excluding exercise-induced asthma)
- Reported febrile upper respiratory illness (oral or tympanic temperature greater than 100°F or a subjective fever) at the time of or within the 24 hours prior to immunization
- Known to be pregnant, possibly pregnant or breast-feeding
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 |
|---|---|---|
| FluMistAlso: influenza virus vaccine LAIV4FluMist Intranasal Vaccine | Drug | Healthcare Worker Administration, Self-Administration |
Primary outcome
Post-vaccination Geometric Mean Titer (GMT) Ratios Between HCWA and SA Subjects
Time frame: 28+/- 7 days post-vaccination
2 secondary outcomes
Difference and Proportion in Seroresponse of Subjects
Time frame: 28+/- 7 days post-vaccination
Difference and Proportion in Seroconversion of Subjects
Time frame: 28+/- 7 days post-vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26117150Burgess TH, Murray CK, Bavaro MF, Landrum ML, O'Bryan TA, Rosas JG, Cammarata SM, Martin NJ, Ewing D, Raviprakash K, Mor D, Zell ER, Wilkins KJ, Millar EV. Self-administration of intranasal influenza vaccine: Immunogenicity and volunteer acceptance. Vaccine. 2015 Jul 31;33(32):3894-9. doi: 10.1016/j.vaccine.2015.06.061. Epub 2015 Jun 25.
- Individual participant dataSharing planned: No. Sharing of individual participant data (IPD) would require revisions and additional regulatory approval, that will not be pursued.
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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.
Timothy Burgess, MD, MPH study director
Uniformed Services University of the Health Sciences
2 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 FluMist in people with Influenza, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 2 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 4 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 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 12 Sep 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?
Post-vaccination Geometric Mean Titer (GMT) Ratios Between HCWA and SA Subjects (time frame: 28+/- 7 days post-vaccination). 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 NCT01933048, 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 15 Feb 2023.