Trial Outcomes & Findings for A Study to Evaluate the Shedding and Safety of Trivalent Influenza Virus Vaccine Live, Intranasal in Infants and Young Children (NCT NCT00344305)
NCT ID: NCT00344305
Last Updated: 2017-07-24
Results Overview
Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by polymerase chain reaction (PCR) based assays. Viral shedding (A/New Caledonia/20/99 \[H1N1\]; A/Wyoming/03/2003 \[H3N2\] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like\]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.
COMPLETED
PHASE2
200 participants
Days 1-28 after study vaccination (up to Day 28)
2017-07-24
Participant Flow
A total of 200 participants were enrolled in the study from 15-May-2006 through 22-Jun-2006 at 16 sites in the United States of America.
A total of 200 participants were stratified on the basis of their age into two cohorts: Cohort 1 (participants aged between 6 to less than \[\<\] 24 months) and Cohort 2 (participants aged between 24 to \< 60 months).
Participant milestones
| Measure |
Cohort 1: Participants Between 6 to < 24 Months Age
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
Cohort 2: Participants Between 24 to < 60 Months Age
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
98
|
99
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1: Participants Between 6 to < 24 Months Age
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
Cohort 2: Participants Between 24 to < 60 Months Age
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Participant was not contacted in window
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Shedding and Safety of Trivalent Influenza Virus Vaccine Live, Intranasal in Infants and Young Children
Baseline characteristics by cohort
| Measure |
Cohort 1: Participants Between 6 to < 24 Months Age
n=100 Participants
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
Cohort 2: Participants Between 24 to < 60 Months Age
n=100 Participants
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.87 months
STANDARD_DEVIATION 5.50 • n=5 Participants
|
41.31 months
STANDARD_DEVIATION 9.98 • n=7 Participants
|
28.09 months
STANDARD_DEVIATION 15.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
93 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
178 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
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
History of laboratory-confirmed influenza illness in previous influenza season
Yes
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
History of laboratory-confirmed influenza illness in previous influenza season
No
|
99 participants
n=5 Participants
|
98 participants
n=7 Participants
|
197 participants
n=5 Participants
|
|
History of receiving an influenza vaccine
Yes
|
43 participants
n=5 Participants
|
73 participants
n=7 Participants
|
116 participants
n=5 Participants
|
|
History of receiving an influenza vaccine
No
|
57 participants
n=5 Participants
|
27 participants
n=7 Participants
|
84 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1-28 after study vaccination (up to Day 28)Population: Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome.
Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by polymerase chain reaction (PCR) based assays. Viral shedding (A/New Caledonia/20/99 \[H1N1\]; A/Wyoming/03/2003 \[H3N2\] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like\]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.
Outcome measures
| Measure |
Cohort 1: Participants Between 6 to < 24 Months Age
n=99 Participants
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
Cohort 2: Participants Between 24 to < 60 Months Age
n=100 Participants
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
|---|---|---|
|
Percentage of Participants Who Shed Any Vaccine Virus
|
88.9 percentage of participants
Interval 81.0 to 94.3
|
69.0 percentage of participants
Interval 59.0 to 77.9
|
PRIMARY outcome
Timeframe: Days 1-28 after study vaccination (up to Day 28)Population: Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome.
Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by PCR based assays. Viral shedding (A/New Caledonia/20/99 \[H1N1\]; A/Wyoming/03/2003 \[H3N2\] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like\]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.
Outcome measures
| Measure |
Cohort 1: Participants Between 6 to < 24 Months Age
n=99 Participants
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
Cohort 2: Participants Between 24 to < 60 Months Age
n=100 Participants
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
|---|---|---|
|
Percentage of Participants Who Shed A/H1N1 Vaccine Virus
|
76.8 percentage of participants
Interval 67.2 to 84.7
|
52.0 percentage of participants
Interval 41.8 to 62.1
|
PRIMARY outcome
Timeframe: Days 1-28 after study vaccination (up to Day 28)Population: Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome.
Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by PCR based assays. Viral shedding (A/New Caledonia/20/99 \[H1N1\]; A/Wyoming/03/2003 \[H3N2\] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like\]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.
Outcome measures
| Measure |
Cohort 1: Participants Between 6 to < 24 Months Age
n=99 Participants
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
Cohort 2: Participants Between 24 to < 60 Months Age
n=100 Participants
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
|---|---|---|
|
Percentage of Participants Who Shed A/H3N2 Vaccine Virus
|
57.6 percentage of participants
Interval 47.2 to 67.5
|
15.0 percentage of participants
Interval 8.6 to 23.5
|
PRIMARY outcome
Timeframe: Days 1-28 after study vaccination (up to Day 28)Population: Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome.
Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by PCR based assays. Viral shedding (A/New Caledonia/20/99 \[H1N1\]; A/Wyoming/03/2003 \[H3N2\] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like\]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.
Outcome measures
| Measure |
Cohort 1: Participants Between 6 to < 24 Months Age
n=99 Participants
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
Cohort 2: Participants Between 24 to < 60 Months Age
n=100 Participants
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
|---|---|---|
|
Percentage of Participants Who Shed B Vaccine Virus
|
37.4 percentage of participants
Interval 27.9 to 47.7
|
37.0 percentage of participants
Interval 27.6 to 47.2
|
SECONDARY outcome
Timeframe: Days 1-28 after study vaccination (up to Day 28)Population: Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.
The number of days of shedding was summarized for all participants who shed any vaccine virus.
Outcome measures
| Measure |
Cohort 1: Participants Between 6 to < 24 Months Age
n=88 Participants
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
Cohort 2: Participants Between 24 to < 60 Months Age
n=69 Participants
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
|---|---|---|
|
Duration of Any Vaccine Virus Shedding
|
3.0 days
Standard Deviation 1.5
|
2.7 days
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Days 1-28 after study vaccination (up to Day 28)Population: Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.
The number of days of shedding was summarized for all participants who shed confirmed A/H1N1 strain virus.
Outcome measures
| Measure |
Cohort 1: Participants Between 6 to < 24 Months Age
n=76 Participants
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
Cohort 2: Participants Between 24 to < 60 Months Age
n=52 Participants
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
|---|---|---|
|
Duration of Confirmed A/H1N1 Vaccine Virus Shedding
|
2.1 days
Standard Deviation 1.0
|
2.2 days
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Days 1-28 after study vaccination (up to Day 28)Population: Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.
The number of days of shedding was summarized for all participants who shed confirmed A/H3N2 strain virus.
Outcome measures
| Measure |
Cohort 1: Participants Between 6 to < 24 Months Age
n=57 Participants
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
Cohort 2: Participants Between 24 to < 60 Months Age
n=15 Participants
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
|---|---|---|
|
Duration of Confirmed A/H3N2 Vaccine Virus Shedding
|
1.8 days
Standard Deviation 0.9
|
1.7 days
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Days 1-28 after study vaccination (up to Day 28)Population: Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.
The number of days of shedding was summarized for all participants who shed confirmed B strain virus.
Outcome measures
| Measure |
Cohort 1: Participants Between 6 to < 24 Months Age
n=37 Participants
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
Cohort 2: Participants Between 24 to < 60 Months Age
n=37 Participants
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
|---|---|---|
|
Duration of Confirmed B Vaccine Virus Shedding
|
2.1 days
Standard Deviation 1.5
|
1.8 days
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Days 1-28 after study vaccination (up to Day 28)Population: Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.
Quantitation of confirmed A/H1N1 shed vaccine virus was evaluated using the log transformed median tissue culture infectious dose (TCID50) per (/) millilitre (mL) for A/H1N1 vaccine strain and summarized for all participants who shed vaccine virus.
Outcome measures
| Measure |
Cohort 1: Participants Between 6 to < 24 Months Age
n=52 Participants
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
Cohort 2: Participants Between 24 to < 60 Months Age
n=45 Participants
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
|---|---|---|
|
Quantitation of Confirmed A/H1N1 Shed Vaccine Virus on Any Day
|
2.14 log (TCID50)/mL
Standard Deviation 0.98
|
2.62 log (TCID50)/mL
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Days 1-28 after study vaccination (up to Day 28)Population: Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.
Quantitation of confirmed A/H3N2 shed vaccine virus was evaluated using the log (TCID50)/mL for A/H3N2 vaccine strain and summarized for all participants who shed vaccine virus.
Outcome measures
| Measure |
Cohort 1: Participants Between 6 to < 24 Months Age
n=24 Participants
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
Cohort 2: Participants Between 24 to < 60 Months Age
n=5 Participants
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
|---|---|---|
|
Quantitation of Confirmed A/H3N2 Shed Vaccine Virus on Any Day
|
1.59 log (TCID50)/mL
Standard Deviation 0.95
|
1.10 log (TCID50)/mL
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: Days 1-28 after study vaccination (up to Day 28)Population: Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.
Quantitation of confirmed B shed vaccine virus was evaluated using the log (TCID50)/mL for B vaccine strain and summarized for all participants who shed vaccine virus.
Outcome measures
| Measure |
Cohort 1: Participants Between 6 to < 24 Months Age
n=28 Participants
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
Cohort 2: Participants Between 24 to < 60 Months Age
n=29 Participants
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
|---|---|---|
|
Quantitation of Confirmed B Shed Vaccine Virus on Any Day
|
1.70 log (TCID50)/mL
Standard Deviation 1.09
|
1.24 log (TCID50)/mL
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: Days 1-28 after study vaccination (up to Day 28)Population: Shedding population: all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified category.
The genetic and phenotypic stability of shed vaccine virus was evaluated by determination of genomic sequence and assessment of the cold-adapted (ca) and temperature-sensitive (ts) phenotypes. Viruses were considered ts if their titer at 39 degrees Celsius (°C) was at least two logs (100-fold) lower than their titer at 33°C. Viruses were considered ca if they replicated at 25°C to a titer that was no more than two logs (100-fold) lower than the titer at 33°C. After additional phenotypic and genotypic analyses, all evaluable samples retained the ca and ts phenotypes.
Outcome measures
| Measure |
Cohort 1: Participants Between 6 to < 24 Months Age
n=93 Participants
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
Cohort 2: Participants Between 24 to < 60 Months Age
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
|---|---|---|
|
Number of Participants With Genotypic and Phenotypic Stability of A/H1N1 Shed Vaccine Virus
Genotypic Stability (n=0)
|
NA participants
Data not available because no participant was evaluable for the specified category.
|
—
|
|
Number of Participants With Genotypic and Phenotypic Stability of A/H1N1 Shed Vaccine Virus
Phenotypic Stability (n=93)
|
90 participants
|
—
|
SECONDARY outcome
Timeframe: Days 1-28 after study vaccination (up to Day 28)Population: Shedding population: all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified category.
The genetic and phenotypic stability of shed vaccine virus was evaluated by determination of genomic sequence and assessment of the ca and ts phenotypes. Viruses were considered ts if their titer at 39°C was at least two logs (100-fold) lower than their titer at 33°C. Viruses were considered ca if they replicated at 25°C to a titer that was no more than two logs (100-fold) lower than the titer at 33°C. After additional phenotypic and genotypic analyses, all evaluable samples retained the ca and ts phenotypes.
Outcome measures
| Measure |
Cohort 1: Participants Between 6 to < 24 Months Age
n=39 Participants
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
Cohort 2: Participants Between 24 to < 60 Months Age
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
|---|---|---|
|
Number of Participants With Genotypic and Phenotypic Stability of A/H3N2 Shed Vaccine Virus
Phenotypic Stability (n=39)
|
37 participants
|
—
|
|
Number of Participants With Genotypic and Phenotypic Stability of A/H3N2 Shed Vaccine Virus
Genotypic Stability (n=0)
|
NA participants
Data not available because no participant was evaluable for the specified category.
|
—
|
SECONDARY outcome
Timeframe: Days 1-28 after study vaccination (up to Day 28)Population: Shedding population: all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified category.
The genetic and phenotypic stability of shed vaccine virus was evaluated by determination of genomic sequence and assessment of the ca and ts phenotypes. Viruses were considered ts if their titer at 37°C was at least two logs (100-fold) lower than their titer at 33°C. Viruses were considered ca if they replicated at 25°C to a titer that was no more than two logs (100-fold) lower than the titer at 33°C. After additional phenotypic and genotypic analyses, all evaluable samples retained the ca and ts phenotypes.
Outcome measures
| Measure |
Cohort 1: Participants Between 6 to < 24 Months Age
n=61 Participants
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
Cohort 2: Participants Between 24 to < 60 Months Age
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
|---|---|---|
|
Number of Participants With Genotypic and Phenotypic Stability of B Shed Vaccine Virus
Genotypic Stability (n=33)
|
33 participants
|
—
|
|
Number of Participants With Genotypic and Phenotypic Stability of B Shed Vaccine Virus
Phenotypic Stability (n=61)
|
29 participants
|
—
|
SECONDARY outcome
Timeframe: Days 0-28 after vaccination (up to Day 28)Population: Safety population included all participants who received any study drug and had experienced any follow-up for safety.
REs were predefined solicited events that could potentially occur after vaccination. The REs for this study were fever, runny/stuffy nose, sore throat, cough, vomiting, headache, abdominal pain (stomach ache), muscle ache, chills, decreased activity level (lethargy), decreased appetite, and irritability. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Outcome measures
| Measure |
Cohort 1: Participants Between 6 to < 24 Months Age
n=100 Participants
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
Cohort 2: Participants Between 24 to < 60 Months Age
n=100 Participants
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
|---|---|---|
|
Number of Participants With Reactogenicity Events (REs) and Adverse Events (AEs) Through 28 Days Post Vaccination
Any REs
|
84 participants
|
77 participants
|
|
Number of Participants With Reactogenicity Events (REs) and Adverse Events (AEs) Through 28 Days Post Vaccination
AEs
|
48 participants
|
31 participants
|
SECONDARY outcome
Timeframe: Days 0-180 after vaccination (up to 6.5 months)Population: Safety population included all participants who received any study drug and had experienced any follow-up for safety.
An SAE was 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. An SNMC is defined as a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. SNMCs included, but were not limited to, diabetes, asthma, autoimmune disease (lupus, rheumatoid arthritis), and neurological disease (epilepsy, autism).
Outcome measures
| Measure |
Cohort 1: Participants Between 6 to < 24 Months Age
n=100 Participants
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
Cohort 2: Participants Between 24 to < 60 Months Age
n=100 Participants
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC) Through 180 Days Post Vaccination
SAEs
|
1 participants
|
0 participants
|
|
Number of Participants With Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC) Through 180 Days Post Vaccination
SNMC
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Days 0-28 after study vaccination (up to Day 28)Population: Safety population included all participants who received any study drug and had experienced any follow-up for safety. Here, number of participants analyzed signified those participants who had REs.
REs were predefined solicited events that could potentially occur after vaccination. The REs for this study were fever, runny/stuffy nose, sore throat, cough, vomiting, headache, abdominal pain (stomach ache), muscle ache, chills, decreased activity level (lethargy), decreased appetite, and irritability.
Outcome measures
| Measure |
Cohort 1: Participants Between 6 to < 24 Months Age
n=83 Participants
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
Cohort 2: Participants Between 24 to < 60 Months Age
n=77 Participants
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
|---|---|---|
|
Number of Participants With REs in Relation to Any Vaccine Virus Shedding
|
75 participants
|
55 participants
|
Adverse Events
Cohort 2: Participants Between 24 to < 60 Months Age
Cohort 1: Participants Between 6 to < 24 Months Age
Serious adverse events
| Measure |
Cohort 2: Participants Between 24 to < 60 Months Age
n=100 participants at risk
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
Cohort 1: Participants Between 6 to < 24 Months Age
n=100 participants at risk
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/100 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
1.0%
1/100 • Number of events 1 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
Other adverse events
| Measure |
Cohort 2: Participants Between 24 to < 60 Months Age
n=100 participants at risk
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
Cohort 1: Participants Between 6 to < 24 Months Age
n=100 participants at risk
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
|
|---|---|---|
|
Ear and labyrinth disorders
OTORRHOEA
|
0.00%
0/100 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
2.0%
2/100 • Number of events 2 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
|
Eye disorders
CONJUNCTIVITIS
|
0.00%
0/100 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
2.0%
2/100 • Number of events 2 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
|
Gastrointestinal disorders
DIARRHOEA
|
9.0%
9/100 • Number of events 11 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
5.0%
5/100 • Number of events 6 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/100 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
2.0%
2/100 • Number of events 4 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
|
Gastrointestinal disorders
TEETHING
|
0.00%
0/100 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
21.0%
21/100 • Number of events 30 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
|
Infections and infestations
HERPANGINA
|
0.00%
0/100 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
2.0%
2/100 • Number of events 2 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
|
Infections and infestations
OTITIS MEDIA
|
0.00%
0/100 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
4.0%
4/100 • Number of events 4 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
3.0%
3/100 • Number of events 3 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
1.0%
1/100 • Number of events 1 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
|
Infections and infestations
VIRAL INFECTION
|
2.0%
2/100 • Number of events 2 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
3.0%
3/100 • Number of events 4 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
3.0%
3/100 • Number of events 3 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
4.0%
4/100 • Number of events 4 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
|
Injury, poisoning and procedural complications
ARTHROPOD STING
|
2.0%
2/100 • Number of events 2 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
0.00%
0/100 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
|
Investigations
BODY TEMPERATURE INCREASED
|
2.0%
2/100 • Number of events 2 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
3.0%
3/100 • Number of events 4 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
2.0%
2/100 • Number of events 2 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
3.0%
3/100 • Number of events 3 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.00%
0/100 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
2.0%
2/100 • Number of events 2 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
|
Skin and subcutaneous tissue disorders
HEAT RASH
|
2.0%
2/100 • Number of events 2 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
0.00%
0/100 • AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
|
Additional Information
Raburn Mallory MD/ Sr Dir Clinical Development
MedImmune, LLC
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 restricion 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