N/A
Completed N=197,502
A Study to Evaluate the Safety of FluMist in Healthy Children and Healthy Adults
Healthy
Source: ClinicalTrials.gov NCT00113880 ↗
Enrolled (actual)
197,502
Serious AEs
0.3%
Results posted
Jan 2013
Primary outcomePrimary: 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 — 0.33; 0.00; 0.00; 0.00 Cases per 1,000 person-months — p=0.01
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
0.33; 0.00; 0.00; 0.00; 1.46; 0.61 | 0.01 sig |
| PRIMARY Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups |
0.02; 0.16; 0.15; 0.21; 1.19; 3.06 | 0.03 sig |
| PRIMARY Rates of Anaphylaxis and Urticaria in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups |
1.19; 0.89; 0.83; 1.58 | 0.04 sig |
| PRIMARY Rates of MAEs Within the Pre-specified Grouped Diagnoses In The FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups. |
0; 0; 0; 0 | — |
| PRIMARY Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the Within Cohort and Unvaccinated Control Groups |
2.42; 3.42; 2.52; 3.28; 5.59; 3.03 | 0.01 sig |
| PRIMARY Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group |
2.30; 3.20; 3.07; 10.07; 2.43; 7.15 | 0.01 sig |
| PRIMARY Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the Unvaccinated Control Group |
4.07; 4.45; 4.00; 4.81; 3.04; 3.48 | 0.01 sig |
| PRIMARY Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group |
4.06; 8.50; 5.88; 11.45; 3.96; 9.41 | 0.01 sig |
| PRIMARY Rare Events Potentially Related to Wild-type Influenza in FluMist Recipients Compared to TIV and Unvaccinated Control Groups |
0.00; 0.05; 0.00 | 0.04 sig |
| PRIMARY Rates of Serious Adverse Events (SAEs) in FluMist Recipients Compared to Rates in Unvaccinated Control Group |
1.12; 1.72; 1.33; 3.85; 0.98; 1.64 | 0.01 sig |
| PRIMARY Rates of SAEs in FluMist Recipients Compared to Rates in TIV Controls |
1.12; 0.00; 1.33; 0.00; 0.98; 0.23 | 0.01 sig |
| PRIMARY Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in Unvaccinated Controls |
0.97; 1.49; 1.46; 3.36 | 0.01 sig |
| PRIMARY Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in TIV Controls |
0.95; 3.12; 1.46; 9.10 | 0.01 sig |
| SECONDARY 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 |
2.57; 7.03; 10.24; 14.79; 19; 38 | 0.04 sig |
| SECONDARY 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 |
3.74; 1.92; 0.57; 0.77 | 0.02 sig |
| SECONDARY 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 |
1.22; 3.87; 1.82; 5.11; 1.43; 4.28 | 0.01 sig |
| SECONDARY 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 |
2.88; 3.98; 3.11; 4.63; 3.70; 4.93 | 0.01 sig |
| SECONDARY 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 |
2.80; 6.77; 3.19; 8.49; 3.09; 7.37 | 0.01 sig |
| SECONDARY 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 |
0.91; 1.93; 1.75; 5.50 | 0.01 sig |
| SECONDARY Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) |
13.4; 11.0; 7.7; 38.2; 33.4; 38.6 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Must not have had any high risk underlying medical conditions, includig asthma
Data sourced from ClinicalTrials.gov (NCT00113880). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.