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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

5–8 years of age, estimated to be approximately 4,000 new FluMist vaccinees per season

9–17 years of age, estimated to be approximately 5,000 new FluMist vaccinees per season

18–49 years of age, estimated to be approximately 6,000 new FluMist vaccinees per season.

The purpose of this study was to expand the data describing the safety profile of FluMist in the indicated populations (5-8, 9-17, and 18-49 years of age) and to assess the safety of annual revaccination in those who received FluMist in 2 or more consecutive years.

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

The primary objective of this study was to assess the safety of FluMist vaccination by comparing the rates of medically attended events (MAEs) (including serious adverse events [SAEs], anaphylaxis, urticaria, asthma, wheezing, pre-specified grouped diagnoses, and rare events potentially related to wild-type influenza) in FluMist recipients to rates in multiple non-randomized control groups.

Nasal Sprayer dose of FluMist with annual follow up

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Kaiser Permanente Pediactrics

Kaiser Permanente

Kaiser Pediatric Injections

Kaiser Permanente Pediatrics

Kaiser Pediatric Injection Station

Kaiser Permanente-Pediatrics

Kaiser Permanente Injection Clinic

Kaiser Permanente Employee Health

Kaiser Permanente Adult Injection Clinic

Kaiser Permanente Adult Medicine

Kaiser Pediatric Injection Clinic

Kaiser Pediatric Adult Medicine

Kaiser Permanente Medicine Dept.

Kaiser Permanente Injection/Allergy

Kaiser Pediatric Injection Room

Kaiser Permanente Pediatric Injections

Kaiser Permanente Regional Employee Health

Kaiser Permanente Arapahoe

Kaiser Permanente, Aurora Centrepoint

Kaiser Permanente, Boulder

Kaiser Permanente, Baseline

Kaiser Permanente, Broomfield

Kaiser Permanente, East

Kaiser Permanente, Englewood

Kaiser Permanente, Hidden Lake

Kaiser Permanente, Lakewood

Kaiser Permanente, Longmont Primary Care

Kaiser Permanente, Skyline

Kaiser Permanente, Smoky Hill

Kaiser Permanente, Southwest

Kaiser Permanente, Wheatridge

Kaiser Permanente, Westminster

Kaiser Permanente, Point West Clinic Pediatric Injection

Kaiser Permanente, Ken Caryl

Kaiser Permanente Adult Injection

Kaiser Permanente Pharmacy

Post-Marketing Evaluation of the Safety of Influenza Virus Vaccine Live, Intranasal (FluMist) in Healthy Children and Healthy Adults 5-49 Years of Age

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.

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.

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.

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.

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.

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.

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.

Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to TIV controls; there was no significatnly 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.

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.

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.

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.

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.

Age Continuous

Gender data was collected per dose of intervention and not per participant and that each participant could have received more than one dose.

Gender, Male/Female

Breast lump/cyst 

Mastitis 

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.

Breast lump/cyst event rates were presented per 1,000 person-months. If the control group has no event, the relative risk (RR) or hazard ratio (HR) is not estimable.

Breast lump/cyst event rates were presented per 1,000 person-months. If the control group has no event, the RR or HR is not estimable. 

Mastitis event rates were presented per 1,000 person-months. 

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).

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

Heart murmur 

Pregnancy exam, 18-49 yrs 

Pregnancy exam, 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.

Heart murmur event rates were presented per 1,000 person-months.

Pregnancy exam/supervision event rates were presented per 1,000 person-months. 

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).

Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups

Urticaria event rates were presented per 1,000 person-months.

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).

Rates of Anaphylaxis and Urticaria in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups

Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years).

Rates of MAEs Within the Pre-specified Grouped Diagnoses In The FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups.

Any asthma or wheezing event, all ages, 21 d

Any asthma or wheezing event, 21 d, 5-8

Any asthma or wheezing event, 42 d, 18-49

Any asthma or wheezing event rates were presented per 1,000 person-months.

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.

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, all ages

Any asthma or wheezing event, 21 d, 9-17

Any asthma or wheezing event, 21 d, 18-49

Any asthma or wheezing event, 42 d, all ages

Any asthma or wheezing event, 42 d, 5-8

Any asthma or wheezing event, 42 d, 9-17

Any asthma or wheezing event, 42 d, PD2, 5-8

Any asthma or wheezing event rates were presented per 1,000 person-months

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).

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, PD1, all ages

Any asthma or wheezing event, PD1, 9-17

Asthma/RAD, PD1, all ages

Asthma/RAD, PD1, 9-17

Asthma/RAD, PD2, 5-8

Asthma/RAD event rates were presented per 1,000 person-months.

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).

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, 5-8

Any asthma or wheezing event, PD1, 18-49

Any asthma or wheezing event, PD2, 5-8

Asthma/RAD, PD1, 5-8

Asthma/RAD, PD1, 18-49

Wheezing/SOB, PD1, all ages

Wheezing/SOB, PD1, 5-8

Wheezing/SOB, PD1, 9-17

Wheezing/SOB, PD1, 18-49

Asthma/RAD event rates event rates were presented per 1,000 person-months.

Asthma/Rad event rates were presented per 1,000 person-months.

Wheezing/SOB event rates were presented per 1,000 person-months.

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.

Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group

Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to 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.

Encephalitis/encephalopathy event rates were presented per 1,000 person-months.

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.

Rare Events Potentially Related to Wild-type Influenza in FluMist Recipients Compared to TIV and Unvaccinated Control Groups

Any SAE, all ages, 21 days

Any SAE, 18-49, 21 days

Any SAE, all ages, 42 days

Any SAE, 18-49, 42 days

Incident rate comparisons of SAEs with an identified decreased risk associated with FluMist compared to unvaccinated controls; no decreased risk was observed in compariosn to the within cohort control. There were no SAE incidence rate comparisons that were significantly increased in FluMist recipients.

SAE event rates were presented per 1,000 person-months.

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.

Rates of Serious Adverse Events (SAEs) in FluMist Recipients Compared to Rates in Unvaccinated Control Group

Rates of SAEs in FluMist Recipients Compared to Rates in TIV Controls

Any hosp. or death, all ages

Any hosp. or death, 18-49

Hospitalization or death event rates were presented per 1,000 person-months.

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.

Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in Unvaccinated Controls

Any hosp or death, all ages

Any hosp or death, 18-49

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.

Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in TIV Controls

Sinusitis, 18-49 

URI, all ages

URI, 9-17

URI, 18-49 

Any acute resp. tract event, all ages 

Any acute resp. tract event , 9-17 

Any acute resp. tract event ,18-49

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.

Sinusitis event rates were presented per 1,000 person-months.

URI event rates were presented per 1,000 person-months.

Any acute resp. tract event rates were presented per 1,000 person-months.

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.

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, all ages, 42 days

IBS, all ages, 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.

Irritable bowel syndrome event rates were presented per 1,000 person-months. If the control group has no event, the RR or HR is not estimable.

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

Asthma/RAD, all ages

Asthma/RAD, 5-8 

Asthma/RAD, 9-17 

Pharyngitis, all ages 

Pharyngitis, 18-49 

Any acute resp. tract event, all ages

Any acute resp. tract event , 9-17

Any asthma or wheezing event, all ages 

Any asthma or wheezing event, 9-17 

Any asthma or wheezing event,18-49

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.

Pharyngitis event rates were presented per 1,000 person-months.

Any acute respiratory tract event rates were presented per 1,000 person-months.

Any asthma or wheezing event rates were presented 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, all ages 

Any asthma or wheezing event, 9-17

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.

Asthma/RAD event rates were presented per 1,000 person-months. 

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.

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, 18-49 

Any asthma or wheezing event, 5-8

Any asthma or wheezing event,18-49 

Incident rate comparisons of MAEs within 180 days with an identified decreased risk associated with FluMist recipients compared to TIV recipients. There were no MAE incidence rate comparisons that were significantly increased in FluMist recipients compared to TIV recipients.

Rates of MAEs Associated With a Significant Decreased Risk Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in TIV Controls

Incident rate comparisons of SAEs and hospitalizations or deaths with an identified decreased risk associated with FluMist recipients compared to TIV recipients; there were no significant decreases compared to the unvaccinated controls. There were no SAE and hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients compared to their controls.

Analyses were performed by period (180 days) and age group (5-8, 9-17, 18-49 years of age), post Dose 1. recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance was observed for any hospitalization or death, for all ages and 18-49.

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

Fever

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

Arms	Assigned Interventions
1 5–8 years of age, estimated to be approximately 4,000 new FluMist vaccinees per season	Biological/Vaccine: FluMist Nasal Sprayer dose of FluMist with annual follow up
2 9–17 years of age, estimated to be approximately 5,000 new FluMist vaccinees per season	Biological/Vaccine: FluMist Nasal Sprayer dose of FluMist with annual follow up
3 18–49 years of age, estimated to be approximately 6,000 new FluMist vaccinees per season.	Biological/Vaccine: FluMist Nasal Sprayer dose of FluMist with annual follow up

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

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