| 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. | 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). | Posted | | Number | | Cases per 1,000 person-months | | 21 and 42 days | Doses | Participants | | ID | Title | Description |
|---|
| OG000 | FluMist Recipients | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente 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. | | OG001 | Within Cohort Control | FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. 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. | | OG002 | 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). | | OG003 | TIV-Vaccinated Control | 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). |
| | Units | Counts |
|---|
| Participants | - OG00063061
- OG00163061
- OG00271949
- OG003
|
| | Title | Denominators | Categories |
|---|
| Breast lump/cyst | | | Title | Measurements |
|---|
| - OG0000.33
- OG0010.00
- OG0020.00
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| 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. | Exact method or Cox model | | 0.01 | Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment. | | | | | | | | | | | | No | Superiority or Other | | | |
|
| 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. | 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). | Posted | | Number | | Cases per 1,000 person-months | | 21 and 42 days | Doses | Participants | | ID | Title | Description |
|---|
| OG000 | FluMist Recipients | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente 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. | | OG001 | Within Cohort Control | FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. 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. |
|
| 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. | 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). | Posted | | Number | | Cases per 1,000 person-months | | 3 days | Doses | Participants | | ID | Title | Description |
|---|
| OG000 | FluMist Recipients | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente 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. | | OG001 | Within Cohort Control | FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. 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. |
|
| 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. | 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). | Posted | | Number | | Cases per 1,000 person-months | | 21 and 42 days | Doses | Participants | | ID | Title | Description |
|---|
| OG000 | FluMist Recipients | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente 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. | | OG001 | Within Cohort Control | FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. 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. |
|
| 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. | 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. | Posted | | Number | | Cases per 1,000 person-months | | 21 and 42 days | Doses | Participants | | ID | Title | Description |
|---|
| OG000 | FluMist Recipients | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente 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. | | OG001 | Within Cohort Control | FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. 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. |
|
| 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. | 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). | Posted | | Number | | Cases per 1,000 person-months | | 21 and 42 days | Doses | Participants | | ID | Title | Description |
|---|
| OG000 | FluMist Recipients | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente 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. | | OG001 | 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). |
|
| 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. | 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). | Posted | | Number | | Cases per 1,000 person-months | | 180 days | Doses | Participants | | ID | Title | Description |
|---|
| OG000 | FluMist Recipients | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente 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. | | OG001 | 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). |
|
| 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. | 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. | Posted | | Number | | Cases per 1,000 person-months | | 180 days | Doses | Participants | | ID | Title | Description |
|---|
| OG000 | FluMist Recipients | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente 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. | | OG001 | 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). |
|
| 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. | 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. | Posted | | Number | | Cases per 1,000 person-months | | 21 and 42 days | Doses | Participants | | ID | Title | Description |
|---|
| OG000 | FluMist Recipients | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente 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. | | OG001 | 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). |
|
| 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. | 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. | Posted | | Number | | Cases per 1,000 person-months | | 21 and 42 days | Doses | Participants | | ID | Title | Description |
|---|
| OG000 | FluMist Recipients | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente 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. | | OG001 | 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). |
|
| 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. | 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. | Posted | | Number | | Cases per 1,000 person-months | | 21 and 42 days | Doses | Participants | | ID | Title | Description |
|---|
| OG000 | FluMist Recipients | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente 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. | | OG001 | TIV-Vaccinated Control | 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). |
|
| 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. | 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. | Posted | | Number | | Cases per 1,000 person-months | | 180 days | Doses | Participants | | ID | Title | Description |
|---|
| OG000 | FluMist Recipients | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente 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. | | OG001 | 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). |
|
| 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. | 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. | Posted | | Number | | Cases per 1,000 person-months | | 180 days | Doses | Participants | | ID | Title | Description |
|---|
| OG000 | FluMist Recipients | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente 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. | | OG001 | TIV-Vaccinated Control | 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). |
|
| 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. | 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. | Posted | | Number | | Cases per 1,000 person-months | | 21 days | Doses | Participants | | ID | Title | Description |
|---|
| OG000 | FluMist Recipients | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente 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. | | OG001 | Within Cohort Control | FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. 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. |
|
| 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. | 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. | Posted | | Number | | Cases per 1,000 person-months | | 42 days | Doses | Participants | | ID | Title | Description |
|---|
| OG000 | FluMist Recipients | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente 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. | | OG001 | 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). |
|
| 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. | 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. | Posted | | Number | | Cases per 1,000 person-months | | 42 days | Doses | Participants | | ID | Title | Description |
|---|
| OG000 | FluMist Recipients | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente 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. | | OG001 | TIV-Vaccinated Control | 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). |
|
| 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. | 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. | Posted | | Number | | Cases per 1,000 person-months | | 180 days | Doses | Participants | | ID | Title | Description |
|---|
| OG000 | FluMist Recipients | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente 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. | | OG001 | 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). |
|
| 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. | 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. | Posted | | Number | | Cases per 1,000 person-months | | 180 days | Doses | Participants | | ID | Title | Description |
|---|
| OG000 | FluMist Recipients | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente 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. | | OG001 | TIV-Vaccinated Control | 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). |
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| 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. | 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. | Posted | | Number | | Cases per 1,000 person-months | | 180 days | Doses | Participants | | ID | Title | Description |
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| OG000 | FluMist Recipients | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente 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. | | OG001 | TIV-Vaccinated Control | 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). |
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| Secondary | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | | Subsets of FluMist recipients 5-8, 9-17, and 18-49 years of age | Posted | | Number | | Percentage of FluMist recipients | | Within 2-3 days of vaccination | | | | ID | Title | Description |
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| OG000 | FluMist Recipients (5-8 Years Old) | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist. | | OG001 | FluMist Recipients (9-17 Years Old) | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects ≥ 9 years of age were expected to receive only 1 dose. | | OG002 | FluMist Recipients (18-49 Years Old) | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects ≥ 9 years of age were expected to receive only 1 dose. |
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| Secondary | Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) | | Subsets of FluMist recipients 5-8, 9-17, and 18-49 years of age | Posted | | Number | | Percentage of FluMist recipients | | Within 14 days of vaccination | | | | ID | Title | Description |
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| OG000 | FluMist Recipients (5-8 Years Old) | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist. | | OG001 | FluMist Recipients (9-17 Years Old) | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects ≥ 9 years of age were expected to receive only 1 dose. | | OG002 | FluMist Recipients (18-49 Years Old) | Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects ≥ 9 years of age were expected to receive only 1 dose. |
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