Healthy
Conditions
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.
Interventions
BIOLOGICALFluMist
Nasal Sprayer dose of FluMist with annual follow up
Sponsors
MedImmune LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 2-3 days of vaccination | — |
| 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. |
Countries
United States
Participant flow
Recruitment details
Subjects 5 to 49 years of age who were members of the Kaiser Permanente (KP) Health Care Plan at health care centers in Northern California, Colorado, and Hawaii. The first subject vaccinated with FluMist was on 15Oct2003 and the date of the last subject/last assessment was 30Sep2008.
Pre-assignment details
Of 197,502 subjects, 189,174 unique subjects were included in this study, representing the total number of subjects who were defined exclusively within each season. FluMist recipients who received an additional 7,570 FluMist doses were excluded from the analysis based on the presence of high risk underlying medical conditions and other factors.
Participants by arm
| Arm | Count |
|---|---|
| FluMist Recipients Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the KP Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose. FluMist recipients served as their own controls based on the observation time after vaccination. In the primary analyses using within-cohort controls, risk periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to reference observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21. | 63,061 |
| Unvaccinated Control Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California). | 71,949 |
| TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California). | 62,492 |
| Total | 197,502 |
Baseline characteristics
| Characteristic | FluMist Recipients | Unvaccinated Control | TIV-Vaccinated Control | Total |
|---|---|---|---|---|
| Age Continuous | 17.1 Years STANDARD_DEVIATION 12.8 | 17.1 Years STANDARD_DEVIATION 12.8 | 16.8 Years STANDARD_DEVIATION 12.7 | 17.1 Years STANDARD_DEVIATION 12.8 |
| Gender Female | 41593 dose | 41591 dose | 37373 dose | 120557 dose |
| Gender Male | 33116 dose | 33115 dose | 29626 dose | 95857 dose |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 202 / 63,061 |
Outcome results
Primary
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.
Time frame: 21 and 42 days
Population: Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). significance was observed for encephalitis/encephalopathy, for all age groups, across all settings within 42 days, PD1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist Recipients | Rare Events Potentially Related to Wild-type Influenza in FluMist Recipients Compared to TIV and Unvaccinated Control Groups | 0.00 Cases per 1,000 person-months |
| Within Cohort Control | Rare Events Potentially Related to Wild-type Influenza in FluMist Recipients Compared to TIV and Unvaccinated Control Groups | 0.05 Cases per 1,000 person-months |
| Unvaccinated Control | Rare Events Potentially Related to Wild-type Influenza in FluMist Recipients Compared to TIV and Unvaccinated Control Groups | 0.00 Cases per 1,000 person-months |
Comparison: Encephalitis/encephalopathy event rates were presented per 1,000 person-months.p-value: 0.0495% CI: [0, 0.82]Fisher Exact
Primary
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.
Time frame: 3 days
Population: Analyses were performed by period (3 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist Recipients | Rates of Anaphylaxis and Urticaria in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups | 1.19 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Anaphylaxis and Urticaria in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups | 0.89 Cases per 1,000 person-months |
| Unvaccinated Control | Rates of Anaphylaxis and Urticaria in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups | 0.83 Cases per 1,000 person-months |
| TIV-Vaccinated Control | Rates of Anaphylaxis and Urticaria in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups | 1.58 Cases per 1,000 person-months |
Comparison: Urticaria event rates were presented per 1,000 person-months.p-value: 0.0495% CI: [1.02, 4.13]Regression, Cox
Primary
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.
Time frame: 180 days
Population: Analyses performed by period (180 days), age group (5-8, 9-17, 18-49 yrs), setting (clinic, hospital, or ED), and number of doses (1 or 2 for 5-8 yrs). Significance was observed for asthma/RAD, wheezing/shortness of breath (SOB), and any ashtma or wheezing event across all settings, PD1 (all age groups) and PD2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluMist Recipients | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, PD1, 18-49 | 2.27 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, PD2, 5-8 | 5.76 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Asthma/RAD, PD1, all ages | 3.04 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Asthma/RAD, PD1, 5-8 | 3.87 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, PD1, all ages | 4.06 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, PD1, 5-8 | 5.88 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, PD1, 9-17 | 3.96 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Asthma/RAD, PD1, 9-17 | 3.08 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Asthma/RAD, PD1, 18-49 | 2.10 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Asthma/RAD, PD2, 5-8 | 2.18 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Wheezing/SOB, PD1, all ages | 1.15 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Wheezing/SOB, PD1, 5-8 | 2.29 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Wheezing/SOB, PD1, 9-17 | 0.98 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Wheezing/SOB, PD1, 18-49 | 0.19 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, PD1, 9-17 | 9.41 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, PD1, 18-49 | 3.98 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Asthma/RAD, PD1, 5-8 | 9.14 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, PD2, 5-8 | 11.40 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Asthma/RAD, PD2, 5-8 | 7.67 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Asthma/RAD, PD1, all ages | 7.23 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Asthma/RAD, PD1, 9-17 | 8.25 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Wheezing/SOB, PD1, all ages | 1.53 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Wheezing/SOB, PD1, 18-49 | 0.41 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Wheezing/SOB, PD1, 5-8 | 2.77 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, PD1, all ages | 8.50 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Asthma/RAD, PD1, 18-49 | 3.65 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, PD1, 5-8 | 11.45 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Wheezing/SOB, PD1, 9-17 | 1.37 Cases per 1,000 person-months |
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.45, 0.51]Fisher Exact
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-monthsp-value: 0.0195% CI: [0.47, 0.56]Fisher Exact
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.38, 0.46]Fisher Exact
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.49, 0.67]Fisher Exact
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.33, 0.76]Fisher Exact
Comparison: Asthma/RAD event rates event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.39, 0.45]Fisher Exact
Comparison: Asthma/RAD event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.38, 0.47]Fisher Exact
Comparison: Asthma/RAD event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.34, 0.41]Fisher Exact
Comparison: Asthma/RAD event rates were presented per 1,000 person-months.p-value: 0.0595% CI: [0.49, 0.68]Fisher Exact
Comparison: Asthma/Rad event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.15, 0.52]Fisher Exact
Comparison: Wheezing/SOB event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.66, 0.85]Fisher Exact
Comparison: Wheezing/SOB event rates were presented per 1,000 person-months.p-value: 0.0295% CI: [0.7, 0.97]Fisher Exact
Comparison: Wheezing/SOB event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.58, 0.88]Fisher Exact
Comparison: Wheezing/SOB event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.27, 0.78]Fisher Exact
Primary
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.
Time frame: 180 days
Population: Analyses performed by period (180 days), age group (5-8, 9-17, 18-49 yrs), setting (clinic, hospital, or ED), and number of doses (1 or 2 for 5-8 yrs). Significance was observed for asthma/reactive airway disease (RAD) and any ashtma or wheezing event across all settings, PD1 (all ages and 9-17 yrs) and PD2 (5-8 yrs).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluMist Recipients | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the Unvaccinated Control Group | Any asthma or wheezing event, PD1, all ages | 4.07 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the Unvaccinated Control Group | Asthma/RAD, PD1, 9-17 | 3.10 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the Unvaccinated Control Group | Asthma/RAD, PD1, all ages | 3.04 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the Unvaccinated Control Group | Asthma/RAD, PD2, 5-8 | 2.69 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the Unvaccinated Control Group | Any asthma or wheezing event, PD1, 9-17 | 4.00 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the Unvaccinated Control Group | Asthma/RAD, PD2, 5-8 | 5.54 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the Unvaccinated Control Group | Any asthma or wheezing event, PD1, all ages | 4.45 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the Unvaccinated Control Group | Asthma/RAD, PD1, all ages | 3.48 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the Unvaccinated Control Group | Asthma/RAD, PD1, 9-17 | 3.94 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the Unvaccinated Control Group | Any asthma or wheezing event, PD1, 9-17 | 4.81 Cases per 1,000 person-months |
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.86, 0.98]Fisher Exact
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-monthsp-value: 0.0195% CI: [0.75, 0.92]Fisher Exact
Comparison: Asthma/RAD event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.81, 0.94]Fisher Exact
Comparison: Asthma/RAD event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.7, 0.88]Fisher Exact
Comparison: Asthma/RAD event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.29, 0.79]Fisher Exact
Primary
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.
Time frame: 21 and 42 days
Population: Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed across all settings, post Dose 1 within 21 days and 42 days (all age groups) and post Dose 2 (PD2) within 42 days (5-8 yrs).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluMist Recipients | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, 21 d, 5-8 | 3.07 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, 42 d, 5-8 | 4.11 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, 21 d, 18-49 | 1.24 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, 42 d, 9-17 | 2.70 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, 21 d, 9-17 | 2.43 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, 42 d, 18-49 | 1.37 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, 42 d, all ages | 2.76 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, 42 d, PD2, 5-8 | 7.10 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, 21 d, all ages | 2.30 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, 42 d, PD2, 5-8 | 14.99 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, 21 d, all ages | 3.20 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, 21 d, 5-8 | 10.07 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, 21 d, 9-17 | 7.15 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, 21 d, 18-49 | 2.94 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, 42 d, all ages | 7.23 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, 42 d, 5-8 | 10.28 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, 42 d, 9-17 | 7.57 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group | Any asthma or wheezing event, 42 d, 18-49 | 3.37 Cases per 1,000 person-months |
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.27, 0.41]Fisher Exact
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-monthsp-value: 0.0195% CI: [0.22, 0.42]Fisher Exact
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.24, 0.47]Fisher Exact
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.23, 0.75]Fisher Exact
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.33, 0.44]Fisher Exact
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.32, 0.5]Fisher Exact
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.28, 0.45]Fisher Exact
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.27, 0.6]Fisher Exact
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0595% CI: [0.21, 0.99]Fisher Exact
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
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.
Time frame: 21 and 42 days
Population: Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed across all settings, post Dose 1 within 21 days for within cohort and within 42 days for unvaccinated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluMist Recipients | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the Within Cohort and Unvaccinated Control Groups | Any asthma or wheezing event, all ages, 21 d | 2.42 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the Within Cohort and Unvaccinated Control Groups | Any asthma or wheezing event, 21 d, 5-8 | 3.28 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the Within Cohort and Unvaccinated Control Groups | Any asthma or wheezing event, 42 d, 18-49 | 1.48 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the Within Cohort and Unvaccinated Control Groups | Any asthma or wheezing event, 21 d, 5-8 | 5.59 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the Within Cohort and Unvaccinated Control Groups | Any asthma or wheezing event, 42 d, 18-49 | NA Cases per 1,000 person-months |
| Within Cohort Control | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the Within Cohort and Unvaccinated Control Groups | Any asthma or wheezing event, all ages, 21 d | 3.42 Cases per 1,000 person-months |
| Unvaccinated Control | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the Within Cohort and Unvaccinated Control Groups | Any asthma or wheezing event, 21 d, 5-8 | 3.03 Cases per 1,000 person-months |
| Unvaccinated Control | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the Within Cohort and Unvaccinated Control Groups | Any asthma or wheezing event, 42 d, 18-49 | 2.18 Cases per 1,000 person-months |
| Unvaccinated Control | Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the Within Cohort and Unvaccinated Control Groups | Any asthma or wheezing event, all ages, 21 d | 2.52 Cases per 1,000 person-months |
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.56, 0.89]Fisher Exact
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.41, 0.83]Fisher Exact
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0495% CI: [0.46, 0.99]Fisher Exact
Primary
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.
Time frame: 180 days
Population: Analyses were performed by period (180 days), age group (5-8, 9-17, 18-49 years of age), and number of doses (one or two for ages 5-8 years). Significance was observed in the hospital/death setting 180 days post Dose 1, for all ages and 18-49.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluMist Recipients | Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in TIV Controls | Any hosp or death, all ages | 0.95 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in TIV Controls | Any hosp or death, 18-49 | 1.46 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in TIV Controls | Any hosp or death, 18-49 | 9.10 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in TIV Controls | Any hosp or death, all ages | 3.12 Cases per 1,000 person-months |
Comparison: Hospitalization or death event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.26, 0.33]Regression, Cox
Comparison: Hospitalization or death event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.13, 0.18]Regression, Cox
Primary
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.
Time frame: 180 days
Population: Analyses were performed by period (180 days), age group (5-8, 9-17, 18-49 years of age), and number of doses (one or two for ages 5-8 years). Significance was observed in the hospitalization/death setting, 180 days post Dose 1, for all ages and 18-49.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluMist Recipients | Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in Unvaccinated Controls | Any hosp. or death, all ages | 0.97 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in Unvaccinated Controls | Any hosp. or death, 18-49 | 1.46 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in Unvaccinated Controls | Any hosp. or death, all ages | 1.49 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in Unvaccinated Controls | Any hosp. or death, 18-49 | 3.36 Cases per 1,000 person-months |
Comparison: Hospitalization or death event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.57, 0.73]Regression, Cox
Comparison: Hospitalization or death event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.36, 0.51]Regression, Cox
Primary
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.
Time frame: 21 and 42 days
Population: Analyses performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (1 or 2 for ages 5-8 years). Significance observed in the clinic, 21 days post Dose 1 in 1 subj. (heart murmur, all ages combined); 18 and 19 subj.(pregnancy exam, 18-49 and all ages combined).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluMist Recipients | Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups | Heart murmur | 0.02 Cases per 1,000 person-months |
| FluMist Recipients | Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups | Pregnancy exam, all ages combined | 0.37 Cases per 1,000 person-months |
| FluMist Recipients | Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups | Pregnancy exam, 18-49 yrs | 1.19 Cases per 1,000 person-months |
| Within Cohort Control | Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups | Heart murmur | 0.16 Cases per 1,000 person-months |
| Within Cohort Control | Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups | Pregnancy exam, all ages combined | 0.89 Cases per 1,000 person-months |
| Within Cohort Control | Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups | Pregnancy exam, 18-49 yrs | 3.06 Cases per 1,000 person-months |
| Unvaccinated Control | Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups | Pregnancy exam, 18-49 yrs | 23.48 Cases per 1,000 person-months |
| Unvaccinated Control | Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups | Heart murmur | 0.15 Cases per 1,000 person-months |
| Unvaccinated Control | Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups | Pregnancy exam, all ages combined | 7.18 Cases per 1,000 person-months |
| TIV-Vaccinated Control | Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups | Heart murmur | 0.21 Cases per 1,000 person-months |
| TIV-Vaccinated Control | Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups | Pregnancy exam, all ages combined | 20.09 Cases per 1,000 person-months |
| TIV-Vaccinated Control | Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups | Pregnancy exam, 18-49 yrs | 70.41 Cases per 1,000 person-months |
Comparison: Heart murmur event rates were presented per 1,000 person-months.p-value: 0.0395% CI: [0, 0.79]Regression, Cox
Comparison: Heart murmur event rates were presented per 1,000 person-months.p-value: 0.0595% CI: [0.02, 1]Regression, Cox
Comparison: Heart murmur event rates were presented per 1,000 person-months.p-value: 0.0495% CI: [0.01, 0.86]Regression, Cox
Comparison: Pregnancy exam/supervision event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.2, 0.7]Regression, Cox
Comparison: Pregnancy exam/supervision event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.22, 0.74]Regression, Cox
Comparison: Pregnancy exam/supervision event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.03, 0.08]Regression, Cox
Comparison: Pregnancy exam/supervision event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.01, 0.03]Regression, Cox
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.
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.
Time frame: 21 and 42 days
Population: Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist Recipients | 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 Cases per 1,000 person-months |
| Within Cohort Control | 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 Cases per 1,000 person-months |
| Unvaccinated Control | 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 Cases per 1,000 person-months |
| TIV-Vaccinated Control | 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 Cases per 1,000 person-months |
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
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.
Time frame: 21 and 42 days
Population: Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed in the clinic setting, 21 days post Dose 1 in 7 subjects (breast lump/cyst, 9-17 yrs) and in 22 subjects (mastitis, 18-49 yrs).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluMist Recipients | 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 | Breast lump/cyst | 0.33 Cases per 1,000 person-months |
| FluMist Recipients | 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 | Mastitis | 1.46 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Mastitis | 0.61 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Breast lump/cyst | 0.00 Cases per 1,000 person-months |
| Unvaccinated Control | 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 | Breast lump/cyst | 0.00 Cases per 1,000 person-months |
| Unvaccinated Control | 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 | Mastitis | 0.20 Cases per 1,000 person-months |
| TIV-Vaccinated Control | 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 | Breast lump/cyst | 0.00 Cases per 1,000 person-months |
| TIV-Vaccinated Control | 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 | Mastitis | 0.23 Cases per 1,000 person-months |
Comparison: Breast lump/cyst event rates were presented per 1,000 person-months. If the control group has no event, the relative risk (RR) or hazard ratio (HR) is not estimable.p-value: 0.01Exact method or Cox model
Comparison: Breast lump/cyst event rates were presented per 1,000 person-months. If the control group has no event, the RR or HR is not estimable.p-value: 0.01Exact method or Cox model
Comparison: Breast lump/cyst event rates were presented per 1,000 person-months. If the control group has no event, the RR or HR is not estimable.p-value: 0.02Exact method or Cox model
Comparison: Mastitis event rates were presented per 1,000 person-months.p-value: 0.0295% CI: [0.64, 3.92]Regression, Cox
Comparison: Mastitis event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [2.2, 24.54]Regression, Cox
Comparison: Mastitis event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [2.13, 24.13]Regression, Cox
Primary
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.
Time frame: 21 and 42 days
Population: Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed in the any/death setting, 21 and 42 days post Dose 1, for all ages and 18-49.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluMist Recipients | Rates of SAEs in FluMist Recipients Compared to Rates in TIV Controls | Any SAE, all ages, 21 days | 1.12 Cases per 1,000 person-months |
| FluMist Recipients | Rates of SAEs in FluMist Recipients Compared to Rates in TIV Controls | Any SAE, 18-49, 21 days | 1.33 Cases per 1,000 person-months |
| FluMist Recipients | Rates of SAEs in FluMist Recipients Compared to Rates in TIV Controls | Any SAE, all ages, 42 days | 0.98 Cases per 1,000 person-months |
| FluMist Recipients | Rates of SAEs in FluMist Recipients Compared to Rates in TIV Controls | Any SAE, 18-49, 42 days | 1.28 Cases per 1,000 person-months |
| Within Cohort Control | Rates of SAEs in FluMist Recipients Compared to Rates in TIV Controls | Any SAE, 18-49, 42 days | 0.23 Cases per 1,000 person-months |
| Within Cohort Control | Rates of SAEs in FluMist Recipients Compared to Rates in TIV Controls | Any SAE, all ages, 21 days | 0.00 Cases per 1,000 person-months |
| Within Cohort Control | Rates of SAEs in FluMist Recipients Compared to Rates in TIV Controls | Any SAE, all ages, 42 days | 0.23 Cases per 1,000 person-months |
| Within Cohort Control | Rates of SAEs in FluMist Recipients Compared to Rates in TIV Controls | Any SAE, 18-49, 21 days | 0.00 Cases per 1,000 person-months |
Comparison: SAE event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.47, 0.91]Regression, Cox
Comparison: SAE event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.21, 0.57]Regression, Cox
Comparison: SAE event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.47, 0.77]Regression, Cox
Comparison: SAE event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.23, 0.48]Regression, Cox
Primary
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.
Time frame: 21 and 42 days
Population: Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed in the any/death setting, 21 and 42 days post Dose 1, for all ages and 18-49.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluMist Recipients | Rates of Serious Adverse Events (SAEs) in FluMist Recipients Compared to Rates in Unvaccinated Control Group | Any SAE, all ages, 42 days | 0.98 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Serious Adverse Events (SAEs) in FluMist Recipients Compared to Rates in Unvaccinated Control Group | Any SAE, 18-49, 42 days | 1.28 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Serious Adverse Events (SAEs) in FluMist Recipients Compared to Rates in Unvaccinated Control Group | Any SAE, all ages, 21 days | 1.12 Cases per 1,000 person-months |
| FluMist Recipients | Rates of Serious Adverse Events (SAEs) in FluMist Recipients Compared to Rates in Unvaccinated Control Group | Any SAE, 18-49, 21 days | 1.33 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Serious Adverse Events (SAEs) in FluMist Recipients Compared to Rates in Unvaccinated Control Group | Any SAE, 18-49, 21 days | 3.85 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Serious Adverse Events (SAEs) in FluMist Recipients Compared to Rates in Unvaccinated Control Group | Any SAE, all ages, 42 days | 1.64 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Serious Adverse Events (SAEs) in FluMist Recipients Compared to Rates in Unvaccinated Control Group | Any SAE, all ages, 21 days | 1.72 Cases per 1,000 person-months |
| Within Cohort Control | Rates of Serious Adverse Events (SAEs) in FluMist Recipients Compared to Rates in Unvaccinated Control Group | Any SAE, 18-49, 42 days | 3.87 Cases per 1,000 person-months |
Comparison: SAE event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.47, 0.91]Regression, Cox
Comparison: SAE event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.21, 0.57]Regression, Cox
Comparison: SAE event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.47, 0.77]Regression, Cox
Comparison: SAE event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.23, 0.48]Regression, Cox
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
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.
Time frame: 42 days
Population: Analyses performed by period (3, 21, and 42 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluMist Recipients | 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 | Pharyngitis, all ages | 8.18 Cases per 1,000 person-months |
| FluMist Recipients | 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 | Pharyngitis, 18-49 | 2.77 Cases per 1,000 person-months |
| FluMist Recipients | 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 | Any acute resp. tract event, all ages | 30.72 Cases per 1,000 person-months |
| FluMist Recipients | 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 | Any asthma or wheezing event, 9-17 | 2.04 Cases per 1,000 person-months |
| FluMist Recipients | 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 | Asthma/RAD, all ages | 1.22 Cases per 1,000 person-months |
| FluMist Recipients | 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 | Asthma/RAD, 5-8 | 1.82 Cases per 1,000 person-months |
| FluMist Recipients | 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 | Asthma/RAD, 9-17 | 1.43 Cases per 1,000 person-months |
| FluMist Recipients | 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 | Any acute resp. tract event , 9-17 | 24.81 Cases per 1,000 person-months |
| FluMist Recipients | 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 | Any asthma or wheezing event, all ages | 2.04 Cases per 1,000 person-months |
| FluMist Recipients | 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 | Any asthma or wheezing event,18-49 | 0.00 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Any asthma or wheezing event, all ages | 5.31 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Pharyngitis, all ages | 11.06 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Asthma/RAD, 9-17 | 4.28 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Pharyngitis, 18-49 | 7.42 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Any acute resp. tract event, all ages | 36.86 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Any asthma or wheezing event, 9-17 | 5.92 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Any acute resp. tract event , 9-17 | 34.06 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Asthma/RAD, all ages | 3.87 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Any asthma or wheezing event,18-49 | 2.31 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Asthma/RAD, 5-8 | 5.11 Cases per 1,000 person-months |
Comparison: Asthma/RAD event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.15, 0.57]Regression, Cox
Comparison: Asthma/RAD event rates were presented per 1,000 person-months.p-value: 0.0395% CI: [0.12, 0.92]Regression, Cox
Comparison: Asthma/RAD event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.13, 0.74]Regression, Cox
Comparison: Pharyngitis event rates were presented per 1,000 person-months.p-value: 0.0495% CI: [0.55, 0.99]Regression, Cox
Comparison: Pharyngitis event rates were presented per 1,000 person-months.p-value: 0.0495% CI: [0.14, 0.93]Regression, Cox
Comparison: Any acute respiratory tract event rates were presented per 1,000 person-months.p-value: 0.0295% CI: [0.71, 0.97]Regression, Cox
Comparison: Any acute respiratory tract event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.57, 0.92]Regression, Cox
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.22, 0.61]Regression, Cox
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.16, 0.68]Regression, Cox
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0395% CI: [0, 0.82]Fisher Exact
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
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.
Time frame: 21 days
Population: Analyses performed by period (3, 21, and 42 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluMist Recipients | 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 | Sinusitis, 18-49 | 2.57 Cases per 1,000 person-months |
| FluMist Recipients | 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 | URI, all ages | 10.24 Cases per 1,000 person-months |
| FluMist Recipients | 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 | URI, 9-17 | 19 Cases per 1,000 person-months |
| FluMist Recipients | 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 | URI, 9-17 | 7.26 Cases per 1,000 person-months |
| FluMist Recipients | 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 | URI, 18-49 | 11.16 Cases per 1,000 person-months |
| FluMist Recipients | 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 | Any acute resp. tract event, all ages | 29.20 Cases per 1,000 person-months |
| FluMist Recipients | 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 | Any acute resp. tract event , 9-17 | 23.03 Cases per 1,000 person-months |
| FluMist Recipients | 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 | Any acute resp. tract event ,18-49 | 21.54 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Any acute resp. tract event ,18-49 | 30.09 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Sinusitis, 18-49 | 7.03 Cases per 1,000 person-months |
| Within Cohort Control | 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 | URI, 18-49 | 15.86 Cases per 1,000 person-months |
| Within Cohort Control | 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 | URI, all ages | 14.79 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Any acute resp. tract event , 9-17 | 33.15 Cases per 1,000 person-months |
| Within Cohort Control | 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 | URI, 9-17 | 38 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Any acute resp. tract event, all ages | 37.45 Cases per 1,000 person-months |
| Within Cohort Control | 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 | URI, 9-17 | 14.90 Cases per 1,000 person-months |
Comparison: Sinusitis event rates were presented per 1,000 person-months.p-value: 0.0495% CI: [0.03, 0.93]Regression, Cox
Comparison: URI event rates were presented per 1,000 person-months.p-value: 0.0295% CI: [0.4, 0.92]Regression, Cox
Comparison: URI event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.28, 0.84]Fisher Exact
Comparison: URI event rates were presented per 1,000 person-months.p-value: 0.0295% CI: [0.1, 0.78]Regression, Cox
Comparison: Any acute resp. tract event rates were presented per 1,000 person-months.p-value: 0.0295% CI: [0.63, 0.96]Fisher Exact
Comparison: Any acute resp. tract event rates were presented per 1,000 person-months.p-value: 0.0395% CI: [0.5, 0.97]Fisher Exact
Comparison: Any acute resp. tract event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.21, 0.79]Regression, Cox
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
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.
Time frame: 180 days
Population: Analyses performed by period (180 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluMist Recipients | 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 | Asthma/RAD, all ages | 2.80 Cases per 1,000 person-months |
| FluMist Recipients | 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 | Asthma/RAD, 5-8 | 3.19 Cases per 1,000 person-months |
| FluMist Recipients | 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 | Any asthma or wheezing event, 9-17 | 3.82 Cases per 1,000 person-months |
| FluMist Recipients | 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 | Any asthma or wheezing event,18-49 | 1.64 Cases per 1,000 person-months |
| FluMist Recipients | 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 | Asthma/RAD, 9-17 | 3.09 Cases per 1,000 person-months |
| FluMist Recipients | 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 | Asthma/RAD, 18-49 | 1.64 Cases per 1,000 person-months |
| FluMist Recipients | 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 | Any asthma or wheezing event, all ages | 3.62 Cases per 1,000 person-months |
| FluMist Recipients | 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 | Any asthma or wheezing event, 5-8 | 4.86 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Any asthma or wheezing event, 5-8 | 9.94 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Asthma/RAD, all ages | 6.77 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Asthma/RAD, 9-17 | 7.37 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Any asthma or wheezing event, all ages | 7.95 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Any asthma or wheezing event, 9-17 | 8.83 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Asthma/RAD, 18-49 | 3.29 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Any asthma or wheezing event,18-49 | 3.51 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Asthma/RAD, 5-8 | 8.49 Cases per 1,000 person-months |
Comparison: Asthma/RAD event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.33, 0.51]Regression, Cox
Comparison: Asthma/RAD event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.26, 0.55]Regression, Cox
Comparison: Asthma/RAD event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.31, 0.56]Regression, Cox
Comparison: Asthma/RAD event rates were presented per 1,000 person-months.p-value: 0.0295% CI: [0.26, 0.91]Regression, Cox
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.37, 0.55]Regression, Cox
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.35, 0.67]Regression, Cox
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.33, 0.56]Regression, Cox
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.25, 0.85]Regression, Cox
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
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.
Time frame: 180 days
Population: Analyses performed by period (180 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluMist Recipients | 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 | Asthma/RAD, 9-17 | 3.11 Cases per 1,000 person-months |
| FluMist Recipients | 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 | Any asthma or wheezing event, all ages | 3.70 Cases per 1,000 person-months |
| FluMist Recipients | 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 | Any asthma or wheezing event, 9-17 | 3.80 Cases per 1,000 person-months |
| FluMist Recipients | 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 | Asthma/RAD, all ages | 2.88 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Asthma/RAD, all ages | 3.98 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Asthma/RAD, 9-17 | 4.63 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Any asthma or wheezing event, 9-17 | 5.25 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Any asthma or wheezing event, all ages | 4.93 Cases per 1,000 person-months |
Comparison: Asthma/RAD event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.58, 0.91]Regression, Cox
Comparison: Asthma/RAD event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.49, 0.91]Regression, Cox
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.61, 0.92]Regression, Cox
Comparison: Any asthma or wheezing event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.52, 0.91]Regression, Cox
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
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.
Time frame: 42 days
Population: Analyses performed by period (3, 21, and 42 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluMist Recipients | 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 | Sinusitis, all ages, 42 days | 3.74 Cases per 1,000 person-months |
| FluMist Recipients | 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 | IBS, all ages, 42 days | 0.57 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Sinusitis, all ages, 42 days | 1.92 Cases per 1,000 person-months |
| Within Cohort Control | 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 | IBS, all ages, 42 days | 0.77 Cases per 1,000 person-months |
Comparison: Sinusitis event rates were presented per 1,000 person-months.p-value: 0.0295% CI: [1.14, 3.34]Regression, Cox
Comparison: Irritable bowel syndrome event rates were presented per 1,000 person-months. If the control group has no event, the RR or HR is not estimable.p-value: 0.02Exact method or Cox model
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
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.
Time frame: 180 days
Population: Analyses were performed by period (180 days) and age group (5-8, 9-17, 18-49 years of age), post Dose 1. recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance was observed for any hospitalization or death, for all ages and 18-49.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluMist 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 | Any hosp or death, all ages | 0.91 Cases per 1,000 person-months |
| FluMist 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 | Any hosp or death, 18-49 | 1.75 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Any hosp or death, all ages | 1.93 Cases per 1,000 person-months |
| Within Cohort Control | 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 | Any hosp or death, 18-49 | 5.50 Cases per 1,000 person-months |
Comparison: Hospitalization or death event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.32, 0.69]Regression, Cox
Comparison: Hospitalization or death event rates were presented per 1,000 person-months.p-value: 0.0195% CI: [0.17, 0.54]Regression, Cox
Secondary
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
Population: Subsets of FluMist recipients 5-8, 9-17, and 18-49 years of age
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluMist Recipients | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Fever | 8.3 Percentage of FluMist recipients |
| FluMist Recipients | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Runny nose | 34.3 Percentage of FluMist recipients |
| FluMist Recipients | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Cough | 17.6 Percentage of FluMist recipients |
| FluMist Recipients | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Sore throat | 9.5 Percentage of FluMist recipients |
| FluMist Recipients | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Irritability | 5.9 Percentage of FluMist recipients |
| FluMist Recipients | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Chillls | 3.6 Percentage of FluMist recipients |
| FluMist Recipients | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Vomiting | 2.3 Percentage of FluMist recipients |
| FluMist Recipients | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Headache | 9.2 Percentage of FluMist recipients |
| FluMist Recipients | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Muscle aches | 4.3 Percentage of FluMist recipients |
| FluMist Recipients | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Fatigue | 10.8 Percentage of FluMist recipients |
| Within Cohort Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Chillls | 4.2 Percentage of FluMist recipients |
| Within Cohort Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Fever | 6.1 Percentage of FluMist recipients |
| Within Cohort Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Irritability | 4.4 Percentage of FluMist recipients |
| Within Cohort Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Headache | 15.2 Percentage of FluMist recipients |
| Within Cohort Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Runny nose | 30.3 Percentage of FluMist recipients |
| Within Cohort Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Fatigue | 12.9 Percentage of FluMist recipients |
| Within Cohort Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Vomiting | 1.3 Percentage of FluMist recipients |
| Within Cohort Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Cough | 11.4 Percentage of FluMist recipients |
| Within Cohort Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Muscle aches | 5.2 Percentage of FluMist recipients |
| Within Cohort Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Sore throat | 9.0 Percentage of FluMist recipients |
| Unvaccinated Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Vomiting | 0.8 Percentage of FluMist recipients |
| Unvaccinated Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Sore throat | 20.9 Percentage of FluMist recipients |
| Unvaccinated Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Headache | 21.7 Percentage of FluMist recipients |
| Unvaccinated Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Chillls | 7.8 Percentage of FluMist recipients |
| Unvaccinated Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Muscle aches | 12.7 Percentage of FluMist recipients |
| Unvaccinated Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Irritability | 6.8 Percentage of FluMist recipients |
| Unvaccinated Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Fatigue | 18.1 Percentage of FluMist recipients |
| Unvaccinated Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Fever | 6.8 Percentage of FluMist recipients |
| Unvaccinated Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Runny nose | 41.7 Percentage of FluMist recipients |
| Unvaccinated Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Cough | 13.1 Percentage of FluMist recipients |
Secondary
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
Population: Subsets of FluMist recipients 5-8, 9-17, and 18-49 years of age
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluMist Recipients | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Runny nose | 38.2 Percentage of FluMist recipients |
| FluMist Recipients | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Vomiting | 5.7 Percentage of FluMist recipients |
| FluMist Recipients | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Muscle aches | 8.4 Percentage of FluMist recipients |
| FluMist Recipients | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Headache | 11.0 Percentage of FluMist recipients |
| FluMist Recipients | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Fatigue | 12.4 Percentage of FluMist recipients |
| FluMist Recipients | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Irritability | 8.6 Percentage of FluMist recipients |
| FluMist Recipients | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Cough | 25.6 Percentage of FluMist recipients |
| FluMist Recipients | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Fever | 13.4 Percentage of FluMist recipients |
| FluMist Recipients | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Sore throat | 15.8 Percentage of FluMist recipients |
| FluMist Recipients | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Chillls | 5.5 Percentage of FluMist recipients |
| Within Cohort Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Headache | 22.2 Percentage of FluMist recipients |
| Within Cohort Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Cough | 18.8 Percentage of FluMist recipients |
| Within Cohort Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Vomiting | 4.1 Percentage of FluMist recipients |
| Within Cohort Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Runny nose | 33.4 Percentage of FluMist recipients |
| Within Cohort Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Irritability | 5.6 Percentage of FluMist recipients |
| Within Cohort Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Muscle aches | 9.0 Percentage of FluMist recipients |
| Within Cohort Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Chillls | 7.2 Percentage of FluMist recipients |
| Within Cohort Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Sore throat | 17.4 Percentage of FluMist recipients |
| Within Cohort Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Fatigue | 15.0 Percentage of FluMist recipients |
| Within Cohort Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Fever | 11.0 Percentage of FluMist recipients |
| Unvaccinated Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Fatigue | 18.6 Percentage of FluMist recipients |
| Unvaccinated Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Irritability | 7.2 Percentage of FluMist recipients |
| Unvaccinated Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Fever | 7.7 Percentage of FluMist recipients |
| Unvaccinated Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Runny nose | 38.6 Percentage of FluMist recipients |
| Unvaccinated Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Cough | 17.3 Percentage of FluMist recipients |
| Unvaccinated Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Sore throat | 20.3 Percentage of FluMist recipients |
| Unvaccinated Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Headache | 26.8 Percentage of FluMist recipients |
| Unvaccinated Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Chillls | 10.0 Percentage of FluMist recipients |
| Unvaccinated Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Vomiting | 1.6 Percentage of FluMist recipients |
| Unvaccinated Control | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | Muscle aches | 16.8 Percentage of FluMist recipients |