Trial Outcomes & Findings for A Study to Evaluate the Safety of FluMist in Healthy Children and Healthy Adults (NCT NCT00113880)

Last Updated: 2013-01-08

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

63061 participants

Primary outcome timeframe

21 and 42 days

Results posted on

2013-01-08

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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).	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).
Overall Study STARTED	63061	71949	62492
Overall Study COMPLETED	63061	71949	62492
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Safety of FluMist in Healthy Children and Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FluMist Recipients n=63061 Participants 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.	Unvaccinated Control n=71949 Participants 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).	TIV-Vaccinated Control n=62492 Participants 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).	Total n=197502 Participants Total of all reporting groups
Age Continuous	17.1 Years STANDARD_DEVIATION 12.8 • n=5 Participants	17.1 Years STANDARD_DEVIATION 12.8 • n=7 Participants	16.8 Years STANDARD_DEVIATION 12.7 • n=5 Participants	17.1 Years STANDARD_DEVIATION 12.8 • n=4 Participants
Gender Female	41593 dose n=5 Participants	41591 dose n=7 Participants	37373 dose n=5 Participants	120557 dose n=4 Participants
Gender Male	33116 dose n=5 Participants	33115 dose n=7 Participants	29626 dose n=5 Participants	95857 dose n=4 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	FluMist Recipients n=74709 Doses 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.	Within Cohort Control n=74709 Doses 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.	Unvaccinated Control n=74706 Doses 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).	TIV-Vaccinated Control n=66999 Doses 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).
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	0.00 Cases per 1,000 person-months	0.00 Cases per 1,000 person-months	0.00 Cases per 1,000 person-months
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	0.61 Cases per 1,000 person-months	0.20 Cases per 1,000 person-months	0.23 Cases per 1,000 person-months

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	FluMist Recipients n=74709 Doses 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.	Within Cohort Control n=74709 Doses 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.	Unvaccinated Control n=74706 Doses 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).	TIV-Vaccinated Control n=66999 Doses 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).
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	0.16 Cases per 1,000 person-months	0.15 Cases per 1,000 person-months	0.21 Cases per 1,000 person-months
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	3.06 Cases per 1,000 person-months	23.48 Cases per 1,000 person-months	70.41 Cases per 1,000 person-months
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	0.89 Cases per 1,000 person-months	7.18 Cases per 1,000 person-months	20.09 Cases per 1,000 person-months

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	FluMist Recipients n=74709 Doses 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.	Within Cohort Control n=74709 Doses 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.	Unvaccinated Control n=74706 Doses 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).	TIV-Vaccinated Control n=66999 Doses 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).
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	0.89 Cases per 1,000 person-months	0.83 Cases per 1,000 person-months	1.58 Cases per 1,000 person-months

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	FluMist Recipients n=74709 Doses 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.	Within Cohort Control n=74709 Doses 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.	Unvaccinated Control n=74706 Doses 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).	TIV-Vaccinated Control n=66999 Doses 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).
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	0 Cases per 1,000 person-months	0 Cases per 1,000 person-months	0 Cases per 1,000 person-months

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	FluMist Recipients n=63061 Participants 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.	Within Cohort Control n=74709 Doses 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.	Unvaccinated Control n=74706 Doses 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).	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).
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	3.42 Cases per 1,000 person-months	2.52 Cases per 1,000 person-months	—
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	5.59 Cases per 1,000 person-months	3.03 Cases per 1,000 person-months	—
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	NA Cases per 1,000 person-months No data for this timepoint	2.18 Cases per 1,000 person-months	—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	FluMist Recipients n=74709 Doses 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.	Within Cohort Control n=66999 Doses 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.	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).	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).
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	3.20 Cases per 1,000 person-months	—	—
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	10.07 Cases per 1,000 person-months	—	—
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	7.15 Cases per 1,000 person-months	—	—
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	2.94 Cases per 1,000 person-months	—	—
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	7.23 Cases per 1,000 person-months	—	—
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	10.28 Cases per 1,000 person-months	—	—
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	7.57 Cases per 1,000 person-months	—	—
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	3.37 Cases per 1,000 person-months	—	—
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	14.99 Cases per 1,000 person-months	—	—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	FluMist Recipients n=74709 Doses 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.	Within Cohort Control n=74706 Doses 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.	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).	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).
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	4.45 Cases per 1,000 person-months	—	—
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	4.81 Cases per 1,000 person-months	—	—
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	3.48 Cases per 1,000 person-months	—	—
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	3.94 Cases per 1,000 person-months	—	—
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	5.54 Cases per 1,000 person-months	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	FluMist Recipients n=74709 Doses 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.	Within Cohort Control n=66999 Doses 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.	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).	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).
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	8.50 Cases per 1,000 person-months	—	—
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	11.45 Cases per 1,000 person-months	—	—
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	9.41 Cases per 1,000 person-months	—	—
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	3.98 Cases per 1,000 person-months	—	—
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	11.40 Cases per 1,000 person-months	—	—
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	7.23 Cases per 1,000 person-months	—	—
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	9.14 Cases per 1,000 person-months	—	—
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	8.25 Cases per 1,000 person-months	—	—
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	3.65 Cases per 1,000 person-months	—	—
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	7.67 Cases per 1,000 person-months	—	—
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	1.53 Cases per 1,000 person-months	—	—
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	2.77 Cases per 1,000 person-months	—	—
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	1.37 Cases per 1,000 person-months	—	—
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	0.41 Cases per 1,000 person-months	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	FluMist Recipients n=74709 Doses 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.	Within Cohort Control n=66999 Doses 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.	Unvaccinated Control n=74706 Doses 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).	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).
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	0.05 Cases per 1,000 person-months	0.00 Cases per 1,000 person-months	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	FluMist Recipients n=74709 Doses 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.	Within Cohort Control n=74706 Doses 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.	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).	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).
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	1.72 Cases per 1,000 person-months	—	—
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	3.85 Cases per 1,000 person-months	—	—
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	1.64 Cases per 1,000 person-months	—	—
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	3.87 Cases per 1,000 person-months	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	FluMist Recipients n=74709 Doses 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.	Within Cohort Control n=66999 Doses 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.	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).	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).
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	0.00 Cases per 1,000 person-months	—	—
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	0.00 Cases per 1,000 person-months	—	—
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	0.23 Cases per 1,000 person-months	—	—
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	0.23 Cases per 1,000 person-months	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	FluMist Recipients n=63061 Participants 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.	Within Cohort Control n=74706 Doses 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.	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).	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).
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	3.36 Cases per 1,000 person-months	—	—
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	1.49 Cases per 1,000 person-months	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	FluMist Recipients n=74709 Doses 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.	Within Cohort Control n=66999 Doses 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.	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).	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).
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	9.10 Cases per 1,000 person-months	—	—
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	3.12 Cases per 1,000 person-months	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	FluMist Recipients n=74709 Doses 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.	Within Cohort Control n=74709 Doses 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.	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).	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).
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	14.90 Cases per 1,000 person-months	—	—
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	15.86 Cases per 1,000 person-months	—	—
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	14.79 Cases per 1,000 person-months	—	—
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	37.45 Cases per 1,000 person-months	—	—
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	33.15 Cases per 1,000 person-months	—	—
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	30.09 Cases per 1,000 person-months	—	—
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	7.03 Cases per 1,000 person-months	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	FluMist Recipients n=74709 Doses 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.	Within Cohort Control n=74706 Doses 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.	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).	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).
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	1.92 Cases per 1,000 person-months	—	—
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	0.77 Cases per 1,000 person-months	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	FluMist Recipients n=74709 Doses 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.	Within Cohort Control n=66999 Doses 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.	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).	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).
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	3.87 Cases per 1,000 person-months	—	—
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	4.28 Cases per 1,000 person-months	—	—
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	11.06 Cases per 1,000 person-months	—	—
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	34.06 Cases per 1,000 person-months	—	—
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	2.31 Cases per 1,000 person-months	—	—
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	5.11 Cases per 1,000 person-months	—	—
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	7.42 Cases per 1,000 person-months	—	—
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	36.86 Cases per 1,000 person-months	—	—
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	5.31 Cases per 1,000 person-months	—	—
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	5.92 Cases per 1,000 person-months	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	FluMist Recipients n=74709 Doses 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.	Within Cohort Control n=74706 Doses 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.	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).	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).
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	3.98 Cases per 1,000 person-months	—	—
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	4.63 Cases per 1,000 person-months	—	—
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	4.93 Cases per 1,000 person-months	—	—
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	5.25 Cases per 1,000 person-months	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	FluMist Recipients n=74709 Doses 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.	Within Cohort Control n=66999 Doses 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.	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).	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).
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	6.77 Cases per 1,000 person-months	—	—
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	8.49 Cases per 1,000 person-months	—	—
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	7.37 Cases per 1,000 person-months	—	—
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	3.29 Cases per 1,000 person-months	—	—
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	7.95 Cases per 1,000 person-months	—	—
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	9.94 Cases per 1,000 person-months	—	—
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	3.51 Cases per 1,000 person-months	—	—
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	8.83 Cases per 1,000 person-months	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	FluMist Recipients n=74709 Doses 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.	Within Cohort Control n=66999 Doses 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.	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).	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).
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	5.50 Cases per 1,000 person-months	—	—
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	1.93 Cases per 1,000 person-months	—	—

SECONDARY outcome

Timeframe: Within 2-3 days of vaccination

Population: Subsets of FluMist recipients 5-8, 9-17, and 18-49 years of age

Outcome measures

Outcome measures
Measure	FluMist Recipients n=749 Participants 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.	Within Cohort Control n=683 Participants 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.	Unvaccinated Control n=643 Participants 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).	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).
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	6.1 Percentage of FluMist recipients	6.8 Percentage of 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	30.3 Percentage of FluMist recipients	41.7 Percentage of 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	11.4 Percentage of FluMist recipients	13.1 Percentage of 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	9.0 Percentage of FluMist recipients	20.9 Percentage of 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	4.4 Percentage of FluMist recipients	6.8 Percentage of 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	5.2 Percentage of FluMist recipients	12.7 Percentage of 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	12.9 Percentage of FluMist recipients	18.1 Percentage of 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	15.2 Percentage of FluMist recipients	21.7 Percentage of 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	4.2 Percentage of FluMist recipients	7.8 Percentage of 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	1.3 Percentage of FluMist recipients	0.8 Percentage of FluMist recipients	—

SECONDARY outcome

Timeframe: Within 14 days of vaccination

Population: Subsets of FluMist recipients 5-8, 9-17, and 18-49 years of age

Outcome measures

Outcome measures
Measure	FluMist Recipients n=749 Participants 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.	Within Cohort Control n=683 Participants 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.	Unvaccinated Control n=643 Participants 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).	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).
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	11.0 Percentage of FluMist recipients	7.7 Percentage of 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	33.4 Percentage of FluMist recipients	38.6 Percentage of 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	18.8 Percentage of FluMist recipients	17.3 Percentage of 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	17.4 Percentage of FluMist recipients	20.3 Percentage of 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	5.6 Percentage of FluMist recipients	7.2 Percentage of 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	22.2 Percentage of FluMist recipients	26.8 Percentage of 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	7.2 Percentage of FluMist recipients	10.0 Percentage of 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	4.1 Percentage of FluMist recipients	1.6 Percentage of 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	9.0 Percentage of FluMist recipients	16.8 Percentage of 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	15.0 Percentage of FluMist recipients	18.6 Percentage of FluMist recipients	—

Adverse Events

FluMist Recipients

Serious events: 202 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FluMist Recipients n=63061 participants at risk
Blood and lymphatic system disorders Anaemia	0.00% 2/63061 • Number of events 2 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Blood and lymphatic system disorders Lymphadenitis	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Cardiac disorders Angina unstable	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Cardiac disorders Atrial fibrillation	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Cardiac disorders Cardiac failure congestive	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Cardiac disorders Coronary artery disease	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Congenital, familial and genetic disorders Cleft palate	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Congenital, familial and genetic disorders Congenital anomaly	0.00% 3/63061 • Number of events 3 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Congenital, familial and genetic disorders Eye anterior chamber congenital anomaly	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Congenital, familial and genetic disorders Factor ix deficiency	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Congenital, familial and genetic disorders Pierre robin syndrome	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Ear and labyrinth disorders Deafness	0.00% 2/63061 • Number of events 2 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Endocrine disorders Goitre	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Eye disorders Retinal detachment	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Gastrointestinal disorders Abdominal pain	0.01% 5/63061 • Number of events 5 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Gastrointestinal disorders Colitis ulcerative	0.00% 2/63061 • Number of events 2 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Gastrointestinal disorders Constipation	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Gastrointestinal disorders Dyspepsia	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Gastrointestinal disorders Gastric ulcer	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 2/63061 • Number of events 2 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Gastrointestinal disorders Malocclusion	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Gastrointestinal disorders Pancreatitis	0.01% 4/63061 • Number of events 4 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Gastrointestinal disorders Peritoneal adhesions	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Gastrointestinal disorders Tooth disorder	0.00% 2/63061 • Number of events 2 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Gastrointestinal disorders Umbilical hernia	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Gastrointestinal disorders Vomiting	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
General disorders Adverse drug reaction	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
General disorders Chest pain	0.00% 3/63061 • Number of events 3 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Hepatobiliary disorders Cholecystitis	0.00% 2/63061 • Number of events 2 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Hepatobiliary disorders Cholelithiasis	0.01% 4/63061 • Number of events 4 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Infections and infestations Abscess	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Infections and infestations Appendicitis	0.01% 9/63061 • Number of events 9 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Infections and infestations Arthritis bacterial	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Infections and infestations Cellulitis	0.01% 4/63061 • Number of events 4 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Infections and infestations Diverticulitis	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Infections and infestations Gastroenteritis	0.00% 2/63061 • Number of events 2 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Infections and infestations Infectious mononucleosis	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Infections and infestations Osteomyelitis	0.00% 2/63061 • Number of events 2 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Infections and infestations Pelvic inflammatory disease	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Infections and infestations Pneumonia	0.00% 3/63061 • Number of events 3 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Infections and infestations Psoas abscess	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Infections and infestations Rash pustular	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Infections and infestations Sinusitis	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Infections and infestations Staphylococcal bacteraemia	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Infections and infestations Tuberculosis	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Infections and infestations Urinary tract infection	0.00% 2/63061 • Number of events 2 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Infections and infestations Viral infection	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Injury, poisoning and procedural complications Ankle fracture	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Injury, poisoning and procedural complications Comminuted fracture	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Injury, poisoning and procedural complications Drug exposure during pregnancy	0.00% 2/63061 • Number of events 2 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Injury, poisoning and procedural complications Incisional hernia	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Injury, poisoning and procedural complications Injury	0.02% 15/63061 • Number of events 15 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Injury, poisoning and procedural complications Open wound	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Injury, poisoning and procedural complications Overdose	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Injury, poisoning and procedural complications Poisoning	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Injury, poisoning and procedural complications Road traffic accident	0.00% 2/63061 • Number of events 2 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Musculoskeletal and connective tissue disorders Back pain	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Musculoskeletal and connective tissue disorders Kyphosis	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Musculoskeletal and connective tissue disorders Scoliosis	0.00% 2/63061 • Number of events 2 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign hydatidiform mole	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm	0.00% 3/63061 • Number of events 3 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 2/63061 • Number of events 2 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 2/63061 • Number of events 2 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyoma	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-hodgkin's lymphoma	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 3/63061 • Number of events 3 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Nervous system disorders Autism	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Nervous system disorders Cerebrovascular accident	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Nervous system disorders Convulsion	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Nervous system disorders Dystonia	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Nervous system disorders Epilepsy	0.01% 6/63061 • Number of events 6 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Nervous system disorders Febrile convulsion	0.00% 2/63061 • Number of events 2 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Nervous system disorders Headache	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Nervous system disorders Hemicephalalgia	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Nervous system disorders Meningitis eosinophilic	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Nervous system disorders Migraine	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Nervous system disorders Petit mal epilepsy	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Nervous system disorders Syncope	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Nervous system disorders Thoracic outlet syndrome	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Nervous system disorders Viith nerve paralysis	0.01% 4/63061 • Number of events 4 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.01% 8/63061 • Number of events 8 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Pregnancy, puerperium and perinatal conditions Blighted ovum	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.00% 2/63061 • Number of events 2 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Psychiatric disorders Alcohol abuse	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Psychiatric disorders Anorexia nervosa	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Psychiatric disorders Dependence	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Psychiatric disorders Eating disorder	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Psychiatric disorders Major depression	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Psychiatric disorders Mental disorder	0.02% 15/63061 • Number of events 15 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Psychiatric disorders Suicide attempt	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Reproductive system and breast disorders Breast pain	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Reproductive system and breast disorders Endometriosis	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Reproductive system and breast disorders Menstrual disorder	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Reproductive system and breast disorders Uterine prolapse	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Surgical and medical procedures Elective procedure	0.00% 2/63061 • Number of events 2 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Surgical and medical procedures Female sterilisation	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Vascular disorders Deep vein thrombosis	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.
Vascular disorders Kawasaki's disease	0.00% 1/63061 • Number of events 1 • 3, 21, 42 days, and 6 months post vaccination This study assessed for medically attended events (MAEs) not adverse events. 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. Results for MAEs are reported in the Outcome Measures.

Other adverse events

Adverse event data not reported

Additional Information

Chris Ambrose, MD, Sr Director, Medical Affairs

MedImmune, LLC

Phone: 301-398-0000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
Publication restrictions are in place

Restriction type: OTHER