HealthyNCT00113880
A Study to Evaluate the Safety of FluMist in Healthy Children and Healthy Adults
An observational study of Healthy, run by MedImmune LLC at 77 sites in United States.
Trial summary
The purpose of this study was to expand the data describing the safety profile of FluMist in the indicated populations (5-8, 9-17, and 18-49 years of age) and to assess the safety of annual revaccination in those who received FluMist in 2 or more consecutive years. Read more about this study
- Who is it for?
- Ages 5 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- FluMist
- Type of treatment
- Vaccines
- How many people
- 63,061 participants
- Where
- 77 sitesUnited States
- Study dates
- Oct 2003to Jun 2010
- Phase
- Observational
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: This is an observational study conducted over multiple years with multiple non-randomized control groups.
Who may be able to join
- 5-49 years of age
- Members of the Kaiser Permanente (KP) Health Care Plan within KP of Northern California, KP of Colorado, and KP of Hawaii
Who cannot join
- Must not have had any high risk underlying medical conditions, includig asthma
Trial locations and contacts
77 sites in 1 country.
77 sites in 1 country
United States77 sites
Kaiser Permanente Pediatrics
Alameda, California, 94501
Kaiser Permanente Pediatrics
Antioch, California, 94509
Kaiser Permanente, Hidden Lake
Arvada, Colorado, 80003
Kaiser Permanente, Aurora Centrepoint
Aurora, Colorado, 80012
Kaiser Permanente, Smoky Hill
Aurora, Colorado, 80015
Kaiser Permanente, Baseline
Boulder, Colorado, 80302
Kaiser Permanente, Boulder
Boulder, Colorado, 80304
Kaiser Permanente, Broomfield
Broomfield, Colorado, 80020
Kaiser Permanente Pediatrics
Clovis, California, 93611
Kaiser Permanente Pediatrics
Daly City, California, 94015
Kaiser Permanente
Davis, California, 95616
Kaiser Permanente, Skyline
Denver, Colorado, 80205
Kaiser Permanente, East
Denver, Colorado, 80231
Kaiser Permanente, Englewood
Englewood, Colorado, 80110
Kaiser Pediatric Injections
Fairfield, California, 94533
Kaiser Permanente-Pediatrics
Folsom, California, 95630
Kaiser Permanente Adult Injection
Fremont, California, 94538
Kaiser Permanente Pediatrics
Fremont, California, 94543
Kaiser Permanente Pediactrics
Fresno, California, 93726
Kaiser Permanente Pediatrics
Gilroy, California, 93726
Kaiser Pediatric Injection Station
Hayward, California, 94545
Kaiser Permanente
Highlands Ranch, Colorado, 80129
Kaiser Permanente
Lafayette, Colorado, 80026
Kaiser Permanente, Lakewood
Lakewood, Colorado, 80226
Kaiser Permanente
Lincoln, California, 95648
Kaiser Permanente Arapahoe
Littleton, Colorado, 80122
Kaiser Permanente, Southwest
Littleton, Colorado, 80123
Kaiser Permanente, Ken Caryl
Littleton, Colorado, 80127
Kaiser Pediatric Injection Station
Livermore, California, 94551
Kaiser Permanente, Longmont Primary Care
Longmont, Colorado, 80501
Kaiser Permanente Injection Clinic
Manteca, California, 95337
Kaiser Permanente Pediatrics
Martinez, California, 94553
Kaiser Permanente Adult Medicine
Milpitas, California, 95035
Kaiser Permanente Employee Health
Milpitas, California, 95035
Kaiser Permanente Pediatrics
Milpitas, California, 95035
Kaiser Permanente Injection Clinic
Modesto, California, 95356
Kaiser Permanente Medicine Dept.
Modesto, California, 95356
Kaiser Permanente Pediatrics
Mountain View, California, 95356
Kaiser Permanente Pediatrics
Napa, California, 94558
Kaiser Permanente Pediatrics
Novato, California, 94945
Kaiser Permanente Employee Health
Oakland, California, 94611
Kaiser Permanente Injection Clinic
Oakland, California, 94611
Kaiser Permanente Pediatrics
Oakland, California, 94611
Kaiser Permanente Regional Employee Health
Oakland, California, 94612
Kaiser Permanente Pediatrics
Petaluma, California, 94954
Kaiser Permanente Pediatrics
Pleasanton, California, 94588
Kaiser Permanente Pediatrics
Rancho Cordova, California, 95670
Kaiser Permanente
Redwood City, California, 94063
Kaiser Permanente Adult Injection Clinic
Richmond, California, 94804
Kaiser Permanente Pediatrics
Richmond, California, 94804
Kaiser Permanente Pediatrics
Roseville, California, 95661
Kaiser Permanente
Roseville, California, 95661
Kaiser Permanente, Point West Clinic Pediatric Injection
Sacramento, California, 95815
Kaiser Permanente
Sacramento, California, 95815
Kaiser Pediatric Injection Station
Sacramento, California, 95823
Kaiser Permanente Medicine Dept.
Sacramento, California, 95823
Kaiser Permanente Medicine Dept.
San Francisco, California, 94115
Kaiser Permanente Pediatrics
San Francisco, California, 94115
Kaiser Permanente Pharmacy
San Francisco, California, 94115
Kaiser Pediatric Adult Medicine
San Jose, California, 95199
Kaiser Pediatric Injection Clinic
San Jose, California, 95199
Kaiser Permanente Employee Health
San Rafael, California, 94115
Kaiser Permanente Pediatrics
San Rafael, California, 94901
Kaiser Permanente Adult Medicine
Santa Clara, California, 95051
Kaiser Permanente Employee Health
Santa Rosa, California, 95403
Kaiser Permanente Pediatrics
Santa Rosa, California, 95403
Kaiser Permanente Pediatrics
Selma, California, 93662
Kaiser Permanente Injection/Allergy
Stockton, California, 95210
Kaiser Permanente Pediatrics
Tracy, California, 95376
Kaiser Pediatric Injection Room
Vacaville, California, 95688
Kaiser Permanente Adult Medicine
Vacaville, California, 95688
Kaiser Permanente Injection Clinic
Vallejo, California, 94589
Kaiser Permanente Pediatric Injections
Vallejo, California, 94589
Kaiser Permanente Pediatrics
Walnut Creek, California, 94596
Kaiser Permanente Pediatrics
Walnut Creek, California, 94598
Kaiser Permanente, Westminster
Westminster, Colorado, 80234
Kaiser Permanente, Wheatridge
Wheat Ridge, Colorado, 80033
About this study
Official title: Post-Marketing Evaluation of the Safety of Influenza Virus Vaccine Live, Intranasal (FluMist) in Healthy Children and Healthy Adults 5-49 Years of Age
The purpose of this study was to expand the data describing the safety profile of FluMist in the indicated populations (5-8, 9-17, and 18-49 years of age) and to assess the safety of annual revaccination in those who received FluMist in 2 or more consecutive years.
Read the detailed description
The primary objective of this study was to assess the safety of FluMist vaccination by comparing the rates of medically attended events (MAEs) (including serious adverse events [SAEs], anaphylaxis, urticaria, asthma, wheezing, pre-specified grouped diagnoses, and rare events potentially related to wild-type influenza) in FluMist recipients to rates in multiple non-randomized control groups.
- Conditions
- Healthy
- Being tested
- FluMist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluMistBiological
Nasal Sprayer dose of FluMist with annual follow up
FluMistBiological
Nasal Sprayer dose of FluMist with annual follow up
FluMistBiological
Nasal Sprayer dose of FluMist with annual follow up
| Study group | Role | What they receive |
|---|---|---|
| 1 | 5-8 years of age, estimated to be approximately 4,000 new FluMist vaccinees per season Receives: Biological: FluMist | |
| 2 | 9-17 years of age, estimated to be approximately 5,000 new FluMist vaccinees per season Receives: Biological: FluMist | |
| 3 | 18-49 years of age, estimated to be approximately 6,000 new FluMist vaccinees per season. Receives: Biological: FluMist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Medically Attended Events (MAEs) Associated With a Significant Increased Risk in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups
An MAE was defined as a coded medical diagnosis made by a health care provider and associated with a medical encounter (ie, a visit by a health plan member to a medical clinic or ED, or a hospital admission). Incident rate comparisons of MAEs with an identified increased risk associated with FluMist occurring in the same age group and setting across all three comparison groups, as these events are less likely to be due to chance alone.
Measured: 21 and 42 days
Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups
Incident rate comparisons of MAEs with an identified decreased risk associated with FluMist occuring in the same age group and setting across all three comparison groups, as these events are less likely to be due to chance alone. All terms were analyzed for the entire population regardless of gender.
Measured: 21 and 42 days
Rates of Anaphylaxis and Urticaria in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups
Incident rate comparisons associated with a significantly increased risk in FluMist recipients compared to the within cohort control group for urticaria; there was no increased risk compared to the unvaccinated and TIV control groups and there were no anaphylaxis events that occurred within the 3-day risk period post vaccination.
Measured: 3 days
Rates of MAEs Within the Pre-specified Grouped Diagnoses In The FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups.
There were no acute respiratory tract events, acute gastrointestinal tract events, or systemic bacterial infections with an identified increased or decreased risk associated with FluMist occuring in the same age group and setting across all three comparison groups.
Measured: 21 and 42 days
Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the Within Cohort and Unvaccinated Control Groups
Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the within cohort control observed for all ages and 5-8 years of age within 21 days and compared to the unvaccinated control obseved for 18-49 years of age within 42 days. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the within cohort or unvaccinated control groups.
Measured: 21 and 42 days
Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group
Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the TIV control group for all ages, 5-8, 9-17, and 18-49 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the TIV control group.
Measured: 21 and 42 days
Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the Unvaccinated Control Group
Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the unvaccinated control group for all ages, 5-8, and 9-17 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the unvaccinated control group.
Measured: 180 days
Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group
Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the TIV control group for all ages, 5-8, 9-17, and 18-49 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the TIV control group.
Measured: 180 days
Rare Events Potentially Related to Wild-type Influenza in FluMist Recipients Compared to TIV and Unvaccinated Control Groups
Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to TIV controls; there was no significantly decreased risk compared to the within cohort and unvaccinated controls. No MAEs potentially related to wild-type influenza were associated with a significantly increased risk in FluMist recipients.
Measured: 21 and 42 days
Rates of Serious Adverse Events (SAEs) in FluMist Recipients Compared to Rates in Unvaccinated Control Group
Incident rate comparisons of SAEs with an identified decreased risk associated with FluMist compared to unvaccinated controls; no decreased risk was observed in compariosn to the within cohort control. There were no SAE incidence rate comparisons that were significantly increased in FluMist recipients.
Measured: 21 and 42 days
Rates of SAEs in FluMist Recipients Compared to Rates in TIV Controls
Incident rate comparisons of SAEs with an identified decreased risk associated with FluMist compared to TIV controls. There were no SAE incidence rate comparisons that were significantly increased in FluMist recipients.
Measured: 21 and 42 days
Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in Unvaccinated Controls
Incident rate comparisons of hospitalizations and deaths with an identified decreased risk associated with FluMist compared to unvaccinated controls. There were no hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients.
Measured: 180 days
Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in TIV Controls
Incident rate comparisons of hospitalizations and deaths with an identified decreased risk associated with FluMist compared to TIV controls. There were no hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients.
Measured: 180 days
Secondary outcomes (8)
Rates of MAEs Associated With a Significant Decreased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Within Cohort Controls
Incident rate comparisons of MAEs with an identified decreased risk in FluMist recipients receiving FluMist in 2 or more consecutive seasons compared to rates in within cohort controls within 21 days. There was no significant decreased risk in comparison to unvaccinated or TIV controls within the 21-day timeframe.
Measured: 21 days
Rates of MAEs Associated With a Significant Increased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated Controls
Incident rate comparisons of MAEs with an identified increased risk in FluMist recipients receiving FluMist in 2 or more consecutive seasons compared to rates in unvaccinated recipients. There was no increased risk at 3 or 21 days and there was no increased risk compared to the Within Cohort or TIV control groups.
Measured: 42 days
Rates of MAEs Associated With a Significant Decreased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in TIV Controls Within 42 Days
Incident rate comparisons of MAEs with an identified decreased risk in FluMist recipients receiving FluMist in 2 or more consecutive seasons compared to rates in TIV recipients within 42 days. There was no significant decreased risk in comparison to unvaccinated controls within the 42-day timeframe.
Measured: 42 days
Rates of MAEs Associated With a Significant Decreased Risk Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated Controls
Incident rate comparisons of MAEs within 180 days with an identified decreased risk associated with FluMist recipients compared to Unvaccinated Controls. There were no MAE incidence rate comparisons that were significantly increased in FluMist recipients compared to Unvaccinated Controls.
Measured: 180 days
Rates of MAEs Associated With a Significant Decreased Risk Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in TIV Controls
Incident rate comparisons of MAEs within 180 days with an identified decreased risk associated with FluMist recipients compared to TIV recipients. There were no MAE incidence rate comparisons that were significantly increased in FluMist recipients compared to TIV recipients.
Measured: 180 days
Rates of SAEs and Hospitalizations or Deaths Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated and TIV Controls
Incident rate comparisons of SAEs and hospitalizations or deaths with an identified decreased risk associated with FluMist recipients compared to TIV recipients; there were no significant decreases compared to the unvaccinated controls. There were no SAE and hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients compared to their controls.
Measured: 180 days
Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season)
Measured: Within 2-3 days of vaccination
Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season)
Measured: Within 14 days of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2005 (estimated)
- Study startOct 2003
- Primary completionSep 2008
- Study completionJun 2010
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 HealthyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63,061 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Ambrose, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00113880
- Sponsor's protocol ID
- FM025
- Status last verified
- Dec 2012
- First submitted
- 10 Jun 2005
- Last updated
- 8 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Evaluation of the Safety of Influenza Virus Vaccine Live, Intranasal (FluMist) in Healthy Children and Healthy Adults 5-49 Years of Age
- ClinicalTrials.gov ID
- NCT00113880
- Acronym / sponsor ID
- FM025
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63,061 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Sep 2008 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 13 Jun 2005 (estimated)
- Results
- Posted 8 Jan 2013
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 study was to expand the data describing the safety profile of FluMist in the indicated populations (5-8, 9-17, and 18-49 years of age) and to assess the safety of annual revaccination in those who received FluMist in 2 or more consecutive years.
Detailed description
The primary objective of this study was to assess the safety of FluMist vaccination by comparing the rates of medically attended events (MAEs) (including serious adverse events [SAEs], anaphylaxis, urticaria, asthma, wheezing, pre-specified grouped diagnoses, and rare events potentially related to wild-type influenza) in FluMist recipients to rates in multiple non-randomized control groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Biological: FluMist5-8 years of age, estimated to be approximately 4,000 new FluMist vaccinees per season |
| 2 | – | Biological: FluMist9-17 years of age, estimated to be approximately 5,000 new FluMist vaccinees per season |
| 3 | – | Biological: FluMist18-49 years of age, estimated to be approximately 6,000 new FluMist vaccinees per season. |
Who may qualify
- Ages
- 5 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- This is an observational study conducted over multiple years with multiple non-randomized control groups.
Key inclusion criteria (2 listed)
- 5-49 years of age
- Members of the Kaiser Permanente (KP) Health Care Plan within KP of Northern California, KP of Colorado, and KP of Hawaii
Key exclusion criteria (1 listed)
- Must not have had any high risk underlying medical conditions, includig asthma
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 |
|---|---|---|
| FluMistNasal Sprayer dose of FluMist with annual follow up | Biological | 1 |
| FluMistNasal Sprayer dose of FluMist with annual follow up | Biological | 2 |
| FluMistNasal Sprayer dose of FluMist with annual follow up | Biological | 3 |
Primary outcome
Rates of Medically Attended Events (MAEs) Associated With a Significant Increased Risk in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups
Time frame: 21 and 42 days
An MAE was defined as a coded medical diagnosis made by a health care provider and associated with a medical encounter (ie, a visit by a health plan member to a medical clinic or ED, or a hospital admission). Incident rate comparisons of MAEs with an identified increased risk associated with FluMist occurring in the same age group and setting across all three comparison groups, as these events are less likely to be due to chance alone.
Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups
Time frame: 21 and 42 days
Incident rate comparisons of MAEs with an identified decreased risk associated with FluMist occuring in the same age group and setting across all three comparison groups, as these events are less likely to be due to chance alone. All terms were analyzed for the entire population regardless of gender.
Rates of Anaphylaxis and Urticaria in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups
Time frame: 3 days
Incident rate comparisons associated with a significantly increased risk in FluMist recipients compared to the within cohort control group for urticaria; there was no increased risk compared to the unvaccinated and TIV control groups and there were no anaphylaxis events that occurred within the 3-day risk period post vaccination.
Rates of MAEs Within the Pre-specified Grouped Diagnoses In The FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups.
Time frame: 21 and 42 days
There were no acute respiratory tract events, acute gastrointestinal tract events, or systemic bacterial infections with an identified increased or decreased risk associated with FluMist occuring in the same age group and setting across all three comparison groups.
Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the Within Cohort and Unvaccinated Control Groups
Time frame: 21 and 42 days
Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the within cohort control observed for all ages and 5-8 years of age within 21 days and compared to the unvaccinated control obseved for 18-49 years of age within 42 days. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the within cohort or unvaccinated control groups.
Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group
Time frame: 21 and 42 days
Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the TIV control group for all ages, 5-8, 9-17, and 18-49 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the TIV control group.
Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the Unvaccinated Control Group
Time frame: 180 days
Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the unvaccinated control group for all ages, 5-8, and 9-17 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the unvaccinated control group.
Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group
Time frame: 180 days
Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the TIV control group for all ages, 5-8, 9-17, and 18-49 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the TIV control group.
Rare Events Potentially Related to Wild-type Influenza in FluMist Recipients Compared to TIV and Unvaccinated Control Groups
Time frame: 21 and 42 days
Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to TIV controls; there was no significantly decreased risk compared to the within cohort and unvaccinated controls. No MAEs potentially related to wild-type influenza were associated with a significantly increased risk in FluMist recipients.
Rates of Serious Adverse Events (SAEs) in FluMist Recipients Compared to Rates in Unvaccinated Control Group
Time frame: 21 and 42 days
Incident rate comparisons of SAEs with an identified decreased risk associated with FluMist compared to unvaccinated controls; no decreased risk was observed in compariosn to the within cohort control. There were no SAE incidence rate comparisons that were significantly increased in FluMist recipients.
Rates of SAEs in FluMist Recipients Compared to Rates in TIV Controls
Time frame: 21 and 42 days
Incident rate comparisons of SAEs with an identified decreased risk associated with FluMist compared to TIV controls. There were no SAE incidence rate comparisons that were significantly increased in FluMist recipients.
Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in Unvaccinated Controls
Time frame: 180 days
Incident rate comparisons of hospitalizations and deaths with an identified decreased risk associated with FluMist compared to unvaccinated controls. There were no hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients.
Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in TIV Controls
Time frame: 180 days
Incident rate comparisons of hospitalizations and deaths with an identified decreased risk associated with FluMist compared to TIV controls. There were no hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients.
8 secondary outcomes
Rates of MAEs Associated With a Significant Decreased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Within Cohort Controls
Time frame: 21 days
Rates of MAEs Associated With a Significant Increased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated Controls
Time frame: 42 days
Rates of MAEs Associated With a Significant Decreased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in TIV Controls Within 42 Days
Time frame: 42 days
Rates of MAEs Associated With a Significant Decreased Risk Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated Controls
Time frame: 180 days
Rates of MAEs Associated With a Significant Decreased Risk Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in TIV Controls
Time frame: 180 days
Rates of SAEs and Hospitalizations or Deaths Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated and TIV Controls
Time frame: 180 days
Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season)
Time frame: Within 2-3 days of vaccination
Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season)
Time frame: Within 14 days of vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Christopher Ambrose, M.D. study director
MedImmune LLC
77 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by MedImmune LLC at 77 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 2 inclusion and 1 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 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2013). 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?
Rates of Medically Attended Events (MAEs) Associated With a Significant Increased Risk in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups (time frame: 21 and 42 days). The study lists 13 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 8 Jan 2013.