A Study to Evaluate the Safety of FluMist in Healthy Children and Healthy Adults
- Conditions
- Healthy
- Interventions
- Biological: FluMist
- Registration Number
- NCT00113880
- Lead Sponsor
- MedImmune LLC
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63061
- 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
- Must not have had any high risk underlying medical conditions, includig asthma
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 FluMist 5-8 years of age, estimated to be approximately 4,000 new FluMist vaccinees per season 2 FluMist 9-17 years of age, estimated to be approximately 5,000 new FluMist vaccinees per season 3 FluMist 18-49 years of age, estimated to be approximately 6,000 new FluMist vaccinees per season.
- Primary Outcome Measures
Name Time Method 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 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 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 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. 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 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 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 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 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 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 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 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 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 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.
- Secondary Outcome Measures
Name Time Method 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 21 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 within cohort controls within 21 days. There was no significant decreased risk in comparison to unvaccinated or TIV controls within the 21-day timeframe.
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 42 days 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.
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 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.
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 180 days 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.
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 180 days 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.
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 180 days 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.
Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) Within 14 days of vaccination
Trial Locations
- Locations (36)
Kaiser Pediatric Injections
šŗšøFairfield, California, United States
Kaiser Permanente Medicine Dept.
šŗšøSan Francisco, California, United States
Kaiser Permanente Pharmacy
šŗšøSan Francisco, California, United States
Kaiser Permanente Pediatric Injections
šŗšøVallejo, California, United States
Kaiser Permanente, Longmont Primary Care
šŗšøLongmont, Colorado, United States
Kaiser Permanente, Ken Caryl
šŗšøLittleton, Colorado, United States
Kaiser Permanente Injection Clinic
šŗšøVallejo, California, United States
Kaiser Permanente, Aurora Centrepoint
šŗšøAurora, Colorado, United States
Kaiser Permanente-Pediatrics
šŗšøFolsom, California, United States
Kaiser Permanente Pediatrics
šŗšøWalnut Creek, California, United States
Kaiser Permanente
šŗšøLafayette, Colorado, United States
Kaiser Permanente Adult Injection
šŗšøFremont, California, United States
Kaiser Permanente Pediactrics
šŗšøFresno, California, United States
Kaiser Pediatric Injection Station
šŗšøSacramento, California, United States
Kaiser Permanente Adult Medicine
šŗšøVacaville, California, United States
Kaiser Permanente Employee Health
šŗšøSanta Rosa, California, United States
Kaiser Permanente Adult Injection Clinic
šŗšøRichmond, California, United States
Kaiser Permanente Regional Employee Health
šŗšøOakland, California, United States
Kaiser Permanente, Point West Clinic Pediatric Injection
šŗšøSacramento, California, United States
Kaiser Pediatric Adult Medicine
šŗšøSan Jose, California, United States
Kaiser Permanente Injection/Allergy
šŗšøStockton, California, United States
Kaiser Pediatric Injection Clinic
šŗšøSan Jose, California, United States
Kaiser Pediatric Injection Room
šŗšøVacaville, California, United States
Kaiser Permanente, Hidden Lake
šŗšøArvada, Colorado, United States
Kaiser Permanente, Baseline
šŗšøBoulder, Colorado, United States
Kaiser Permanente, Smoky Hill
šŗšøAurora, Colorado, United States
Kaiser Permanente, Boulder
šŗšøBoulder, Colorado, United States
Kaiser Permanente, Broomfield
šŗšøBroomfield, Colorado, United States
Kaiser Permanente, Skyline
šŗšøDenver, Colorado, United States
Kaiser Permanente, East
šŗšøDenver, Colorado, United States
Kaiser Permanente, Englewood
šŗšøEnglewood, Colorado, United States
Kaiser Permanente, Southwest
šŗšøLittleton, Colorado, United States
Kaiser Permanente Arapahoe
šŗšøLittleton, Colorado, United States
Kaiser Permanente, Lakewood
šŗšøLakewood, Colorado, United States
Kaiser Permanente, Westminster
šŗšøWestminster, Colorado, United States
Kaiser Permanente, Wheatridge
šŗšøWheatridge, Colorado, United States