Trial Outcomes & Findings for D2560C00015 FluMist Annual Safety Study 2018 (NCT NCT03564444)
NCT ID: NCT03564444
Last Updated: 2019-12-26
Results Overview
Percentage of participants with fever (oral temperature \>= 101 degrees Fahrenheit) through Day 8 is reported.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
300 participants
Primary outcome timeframe
Day 1 through Day 8
Results posted on
2019-12-26
Participant Flow
The study was conducted between 06Jun2018 and 27Dec2018 in the USA.
Participant milestones
| Measure |
Placebo
Participants received a single dose of placebo matched to bivalent vaccine by intranasal spray.
|
Bivalent Vaccine
Participants received a single dose of bivalent vaccine by intranasal spray.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
240
|
|
Overall Study
COMPLETED
|
60
|
240
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
D2560C00015 FluMist Annual Safety Study 2018
Baseline characteristics by cohort
| Measure |
Placebo
n=60 Participants
Participants received a single dose of placebo matched to bivalent vaccine by intranasal spray.
|
Bivalent Vaccine
n=240 Participants
Participants received a single dose of bivalent vaccine by intranasal spray.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.5 Years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
30.5 Years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
30.3 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=5 Participants
|
228 Participants
n=7 Participants
|
284 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 8Population: The ITT population included all randomized and treated participants, grouped according to actual treatment.
Percentage of participants with fever (oral temperature \>= 101 degrees Fahrenheit) through Day 8 is reported.
Outcome measures
| Measure |
Placebo
n=60 Participants
Participants received a single dose of placebo matched to bivalent vaccine by intranasal spray.
|
Bivalent Vaccine
n=240 Participants
Participants received a single dose of bivalent vaccine by intranasal spray.
|
|---|---|---|
|
Percentage of Participants Reporting Fever (Oral Temperature >= 101 Degrees Fahrenheit) Through Day 8
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 8Population: The ITT population included all randomized and treated participants, grouped according to actual treatment.
For this study, solicited symptoms included oral fever (\> 100 degrees Fahrenheit), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity (tiredness), and headache.
Outcome measures
| Measure |
Placebo
n=60 Participants
Participants received a single dose of placebo matched to bivalent vaccine by intranasal spray.
|
Bivalent Vaccine
n=240 Participants
Participants received a single dose of bivalent vaccine by intranasal spray.
|
|---|---|---|
|
Number of Participants With Solicited Symptoms Through Day 8
>100 degrees Fahrenheit
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Symptoms Through Day 8
>102 degrees Fahrenheit
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Symptoms Through Day 8
>103 degrees Fahrenheit
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Symptoms Through Day 8
Runny nose
|
4 Participants
|
33 Participants
|
|
Number of Participants With Solicited Symptoms Through Day 8
Sore throat
|
2 Participants
|
14 Participants
|
|
Number of Participants With Solicited Symptoms Through Day 8
Cough
|
3 Participants
|
7 Participants
|
|
Number of Participants With Solicited Symptoms Through Day 8
Vomiting
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Symptoms Through Day 8
Muscle aches
|
0 Participants
|
7 Participants
|
|
Number of Participants With Solicited Symptoms Through Day 8
Chills
|
0 Participants
|
3 Participants
|
|
Number of Participants With Solicited Symptoms Through Day 8
Decreased activity (tiredness)
|
2 Participants
|
9 Participants
|
|
Number of Participants With Solicited Symptoms Through Day 8
Headache
|
6 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 15Population: The ITT population included all randomized and treated participants, grouped according to actual treatment.
For this study, solicited symptoms included oral fever (\> 100 degrees Fahrenheit), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity (tiredness), and headache.
Outcome measures
| Measure |
Placebo
n=60 Participants
Participants received a single dose of placebo matched to bivalent vaccine by intranasal spray.
|
Bivalent Vaccine
n=240 Participants
Participants received a single dose of bivalent vaccine by intranasal spray.
|
|---|---|---|
|
Number of Participants With Solicited Symptoms Through Day 15
>100 degrees Fahrenheit
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Symptoms Through Day 15
>=101 degrees Fahrenheit
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Symptoms Through Day 15
>102 degrees Fahrenheit
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Symptoms Through Day 15
>103 degrees Fahrenheit
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Symptoms Through Day 15
Runny nose
|
4 Participants
|
37 Participants
|
|
Number of Participants With Solicited Symptoms Through Day 15
Sore throat
|
4 Participants
|
17 Participants
|
|
Number of Participants With Solicited Symptoms Through Day 15
Cough
|
3 Participants
|
9 Participants
|
|
Number of Participants With Solicited Symptoms Through Day 15
Vomiting
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Symptoms Through Day 15
Muscle aches
|
0 Participants
|
8 Participants
|
|
Number of Participants With Solicited Symptoms Through Day 15
Chills
|
0 Participants
|
4 Participants
|
|
Number of Participants With Solicited Symptoms Through Day 15
Decreased activity (tiredness)
|
3 Participants
|
13 Participants
|
|
Number of Participants With Solicited Symptoms Through Day 15
Headache
|
8 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 8; Day 1 through Day 15Population: The ITT population included all randomized and treated participants, grouped according to actual treatment.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Outcome measures
| Measure |
Placebo
n=60 Participants
Participants received a single dose of placebo matched to bivalent vaccine by intranasal spray.
|
Bivalent Vaccine
n=240 Participants
Participants received a single dose of bivalent vaccine by intranasal spray.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Through Day 8 and Day 15
TEAEs through Day 8
|
1 Participants
|
15 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Through Day 8 and Day 15
TEAEs through Day 15
|
2 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 29; Day 1 through Day 181Population: The ITT population included all randomized and treated participants, grouped according to actual treatment.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Outcome measures
| Measure |
Placebo
n=60 Participants
Participants received a single dose of placebo matched to bivalent vaccine by intranasal spray.
|
Bivalent Vaccine
n=240 Participants
Participants received a single dose of bivalent vaccine by intranasal spray.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Through Day 29 and Day 181
TESAEs through Day 29
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Through Day 29 and Day 181
TESAEs through Day 181
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 29; Day 1 through Day 181Population: The ITT population included all randomized and treated participants, grouped according to actual treatment.
An NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.
Outcome measures
| Measure |
Placebo
n=60 Participants
Participants received a single dose of placebo matched to bivalent vaccine by intranasal spray.
|
Bivalent Vaccine
n=240 Participants
Participants received a single dose of bivalent vaccine by intranasal spray.
|
|---|---|---|
|
Number of Participants With New Onset Chronic Diseases (NOCDs) Through Day 29 and Day 181
NOCDs through Day 29
|
0 Participants
|
0 Participants
|
|
Number of Participants With New Onset Chronic Diseases (NOCDs) Through Day 29 and Day 181
NOCDs through Day 181
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Bivalent Vaccine
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=60 participants at risk
Participants received a single dose of placebo matched to bivalent vaccine by intranasal spray.
|
Bivalent Vaccine
n=240 participants at risk
Participants received a single dose of bivalent vaccine by intranasal spray.
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/60 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
0.42%
1/240 • Number of events 1 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
Other adverse events
| Measure |
Placebo
n=60 participants at risk
Participants received a single dose of placebo matched to bivalent vaccine by intranasal spray.
|
Bivalent Vaccine
n=240 participants at risk
Participants received a single dose of bivalent vaccine by intranasal spray.
|
|---|---|---|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/60 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
0.42%
1/240 • Number of events 1 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/60 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
0.42%
1/240 • Number of events 1 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/60 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
0.42%
1/240 • Number of events 1 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
1/60 • Number of events 1 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
0.42%
1/240 • Number of events 1 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/60 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
1.2%
3/240 • Number of events 3 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
|
General disorders
Chest discomfort
|
0.00%
0/60 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
0.42%
1/240 • Number of events 1 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/60 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
0.42%
1/240 • Number of events 1 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/60 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
0.42%
1/240 • Number of events 1 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/60 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
0.42%
1/240 • Number of events 1 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/60 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
0.42%
1/240 • Number of events 1 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/60 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
0.42%
1/240 • Number of events 1 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/60 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
0.42%
1/240 • Number of events 1 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/60 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
2.1%
5/240 • Number of events 5 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal pruritus
|
1.7%
1/60 • Number of events 1 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
0.00%
0/240 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/60 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
0.42%
1/240 • Number of events 1 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/60 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
0.42%
1/240 • Number of events 1 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/60 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
0.42%
1/240 • Number of events 1 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/60 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
0.83%
2/240 • Number of events 2 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
|
Vascular disorders
Flushing
|
0.00%
0/60 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
0.42%
1/240 • Number of events 1 • For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
Additional Information
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 on going 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.
- Publication restrictions are in place
Restriction type: OTHER