InfluenzaPhase 4NCT00192140
Trial to Assess the Shedding,Immunogenicity, and Safety of FluMist Administered to Healthy Individuals 5-49 Years of Age
A Phase 4 study testing FluMist in people with Influenza, run by MedImmune LLC at 11 sites in United States.
Trial summary
To describe the proportion of individuals 5-49 years of age who shed vaccine strain viruses. To describe the duration of shedding of vaccine viruses in individuals 5-49 years of age. To describe the genotypic and phenotypic stability of shed vaccine viruses. Read more about this study
- Who is it for?
- Ages 5 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- FluMist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 11 sitesUnited States
- Study dates
- Jun 2004to Jan 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 5-49 years of age;
- In good health;
- Individual or parent/guardian available by telephone;
- Ability of the participant or parent/guardian to understand and comply with the requirements of the protocol; and
- Signed informed consent and HIPAA authorization by the participant or parent/guardian.
Who cannot join
- History of hypersensitivity to any component of FluMist, including egg or egg products;
- History of hypersensitivity to gentamicin;
- Close contact who is immunocompromised within the same household;
- Known or suspected immune deficiency diseases or immunosuppressed or have altered or compromised immune status as a consequence of treatment with immunosuppressive therapies;
- History of chronic underlying medical conditions such as chronic disorders of the cardiovascular and pulmonary systems, chronic metabolic diseases (including diabetes), renal dysfunction, or hemoglobinopathies;
- History of Guillain-Barré syndrome;
Show all 18Show fewer
- History of asthma or reactive airways disease;
- Acute febrile (>100.0°F oral) and/or respiratory illness, within the 72 hours prior to enrollment;
- For children and adolescents - use of aspirin or aspirin containing products in the month prior to enrollment or anticipated use during the study;
- Pregnancy or, in biologically capable women (e.g., menses within the last year), not willing to agree to acceptable birth control for three months after enrolling into the study (for those biologically capable, a urine pregnancy test must be performed on the day of vaccination with a negative result);
- Administration of any intranasal medication within two weeks prior to enrollment or expected receipt during this study;
- Administration of any live virus vaccine within one month prior to enrollment or if receipt of another live virus vaccine is expected within one month of the vaccination in this study;
- Administration of any inactivated vaccine within two weeks prior to enrollment or if receipt of another inactivated vaccine is expected within two weeks of the vaccination in this study;
- Participation in another investigational trial or administration of any investigational drug within one month prior to enrollment or during this study;
- Employees of the research center, any individuals involved with the conduct of the study, or any family member of such individuals;
- Laboratory confirmed influenza (positive culture or rapid antigen test) in the prior influenza season (2003/2004 or 2004/2005 season);
- Receipt of any influenza vaccine in the prior influenza season; and
- Any condition that in the opinion of the investigator would interfere with the interpretation or evaluation of the vaccine.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Maryland, School of Medicine
Baltimore, Maryland, 21201
Kentucky Pediatric / Adult Research, Inc
Bardstown, Kentucky, 40004
University of Virginia, Elson Student Health Center
Charlottesville, Virginia, 22904
Children's Memorial Hospital
Chicago, Illinois, 60614
Pediatric Clinical Trials International
Columbus, Ohio, 43205
Marshall University Medical Center
Huntington, West Virginia, 25701
SFBC International, Inc
Miami, Florida, 33181
Vanderbilt University Medical Center North
Nashville, Tennessee, 37232
Creighton University Medical Center
Omaha, Nebraska, 68131
Primary Physician's Research Inc.
Pittsburgh, Pennsylvania, 15241
Center for Vaccine Development
St Louis, Missouri, 63110
About this study
Official title: An Open-Label, Single-Arm Trial to Assess the Shedding, Immunogenicity, and Safety of FluMist Administered to Healthy Individuals 5-49 Years of Age
- To describe the proportion of individuals 5-49 years of age who shed vaccine strain viruses.
- To describe the duration of shedding of vaccine viruses in individuals 5-49 years of age.
- To describe the genotypic and phenotypic stability of shed vaccine viruses.
- To describe the immune responses of FluMist in individuals 5-49 years of age.
- To describe the safety of FluMist in individuals 5-49 years of age in relation to shedding and the immune response
Read the detailed description
The purpose of this study is to evaluate the viral shedding, immunogenicity and safety of FluMist when administered to healthy individuals between 5-49 years of age.
- Conditions
- Influenza
- Being tested
- FluMist
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluMistBiological
A single intranasal dose of FluMist will be administered to approx. 300 subjects.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | FluMist Receives: Biological: FluMist |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the proportion of individuals 5-49 years of age who shed vaccine strain viruses.
Measured: 28 days after vaccination
To describe the duration of shedding of vaccine viruses in individuals 5-49 years of age.
Measured: 28 days after vaccination
Secondary outcomes (2)
To describe the immune responses of FluMist in indivduals 5-49 years of age.
Measured: 28 days after vaccination
To describe the safety of FluMist in individuals 5-49 years of age in relation to shedding and the immune response.
Measured: 28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionOct 2004
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 345 participants
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Walker, MD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192140
- Sponsor's protocol ID
- FM026
- Status last verified
- Dec 2007
- First submitted
- 9 Sep 2005
- Last updated
- 28 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm Trial to Assess the Shedding, Immunogenicity, and Safety of FluMist Administered to Healthy Individuals 5-49 Years of Age
- ClinicalTrials.gov ID
- NCT00192140
- Acronym / sponsor ID
- FM026
- Conditions
- Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Oct 2004 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To describe the proportion of individuals 5-49 years of age who shed vaccine strain viruses.
- To describe the duration of shedding of vaccine viruses in individuals 5-49 years of age.
- To describe the genotypic and phenotypic stability of shed vaccine viruses.
- To describe the immune responses of FluMist in individuals 5-49 years of age.
- To describe the safety of FluMist in individuals 5-49 years of age in relation to shedding and the immune response
Detailed description
The purpose of this study is to evaluate the viral shedding, immunogenicity and safety of FluMist when administered to healthy individuals between 5-49 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: FluMistFluMist |
Who may qualify
- Ages
- 5 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 5-49 years of age;
- In good health;
- Individual or parent/guardian available by telephone;
- Ability of the participant or parent/guardian to understand and comply with the requirements of the protocol; and
- Signed informed consent and HIPAA authorization by the participant or parent/guardian.
Key exclusion criteria (18 listed)
- History of hypersensitivity to any component of FluMist, including egg or egg products;
- History of hypersensitivity to gentamicin;
- Close contact who is immunocompromised within the same household;
- Known or suspected immune deficiency diseases or immunosuppressed or have altered or compromised immune status as a consequence of treatment with immunosuppressive therapies;
- History of chronic underlying medical conditions such as chronic disorders of the cardiovascular and pulmonary systems, chronic metabolic diseases (including diabetes), renal dysfunction, or hemoglobinopathies;
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 |
|---|---|---|
| FluMistA single intranasal dose of FluMist will be administered to approx. 300 subjects. | Biological | 1 |
Primary outcome
To describe the proportion of individuals 5-49 years of age who shed vaccine strain viruses.
Time frame: 28 days after vaccination
To describe the duration of shedding of vaccine viruses in individuals 5-49 years of age.
Time frame: 28 days after vaccination
2 secondary outcomes
To describe the immune responses of FluMist in indivduals 5-49 years of age.
Time frame: 28 days after vaccination
To describe the safety of FluMist in individuals 5-49 years of age in relation to shedding and the immune response.
Time frame: 28 days after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2007.
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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.
Robert Walker, MD study director
Sponsor GmbH
11 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 MedImmune LLC at 11 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 5 inclusion and 18 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 28 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To describe the proportion of individuals 5-49 years of age who shed vaccine strain viruses. (time frame: 28 days after vaccination). The study lists 2 primary outcomes in all. 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 28 Dec 2007.