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A Study to Evaluate the Shedding and Safety of Trivalent Influenza Virus Vaccine Live, Intranasal in Infants and Young Children

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ClinicalTrials.gov Identifier: NCT00344305
Recruitment Status : Completed
First Posted : June 26, 2006
Results First Posted : November 1, 2010
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Intervention Biological: Trivalent influenza virus vaccine live, intranasal
Enrollment 200

Recruitment Details 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.
Pre-assignment Details 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).
Arm/Group Title Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
Hide Arm/Group Description 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). 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).
Period Title: Overall Study
Started 100 100
Completed 98 99
Not Completed 2 1
Reason Not Completed
Lost to Follow-up             2             0
Participant was not contacted in window             0             1
Arm/Group Title Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age Total
Hide Arm/Group Description 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). 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 of all reporting groups
Overall Number of Baseline Participants 100 100 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 100 participants 100 participants 200 participants
14.87  (5.50) 41.31  (9.98) 28.09  (15.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
Female
51
  51.0%
53
  53.0%
104
  52.0%
Male
49
  49.0%
47
  47.0%
96
  48.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
Hispanic or Latino
7
   7.0%
15
  15.0%
22
  11.0%
Not Hispanic or Latino
93
  93.0%
85
  85.0%
178
  89.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
American Indian or Alaska Native
0
   0.0%
1
   1.0%
1
   0.5%
Asian
0
   0.0%
2
   2.0%
2
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
14
  14.0%
7
   7.0%
21
  10.5%
White
86
  86.0%
89
  89.0%
175
  87.5%
More than one race
0
   0.0%
1
   1.0%
1
   0.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
History of laboratory-confirmed influenza illness in previous influenza season  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
Yes 1 2 3
No 99 98 197
History of receiving an influenza vaccine  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
Yes 43 73 116
No 57 27 84
1.Primary Outcome
Title Percentage of Participants Who Shed Any Vaccine Virus
Hide Description 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.
Time Frame Days 1-28 after study vaccination (up to Day 28)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 99 100
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
88.9
(81.0 to 94.3)
69.0
(59.0 to 77.9)
2.Primary Outcome
Title Percentage of Participants Who Shed A/H1N1 Vaccine Virus
Hide Description 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.
Time Frame Days 1-28 after study vaccination (up to Day 28)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 99 100
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
76.8
(67.2 to 84.7)
52.0
(41.8 to 62.1)
3.Primary Outcome
Title Percentage of Participants Who Shed A/H3N2 Vaccine Virus
Hide Description 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.
Time Frame Days 1-28 after study vaccination (up to Day 28)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 99 100
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
57.6
(47.2 to 67.5)
15.0
(8.6 to 23.5)
4.Primary Outcome
Title Percentage of Participants Who Shed B Vaccine Virus
Hide Description 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.
Time Frame Days 1-28 after study vaccination (up to Day 28)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 99 100
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
37.4
(27.9 to 47.7)
37.0
(27.6 to 47.2)
5.Secondary Outcome
Title Duration of Any Vaccine Virus Shedding
Hide Description The number of days of shedding was summarized for all participants who shed any vaccine virus.
Time Frame Days 1-28 after study vaccination (up to Day 28)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 88 69
Mean (Standard Deviation)
Unit of Measure: days
3.0  (1.5) 2.7  (1.6)
6.Secondary Outcome
Title Duration of Confirmed A/H1N1 Vaccine Virus Shedding
Hide Description The number of days of shedding was summarized for all participants who shed confirmed A/H1N1 strain virus.
Time Frame Days 1-28 after study vaccination (up to Day 28)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 76 52
Mean (Standard Deviation)
Unit of Measure: days
2.1  (1.0) 2.2  (1.3)
7.Secondary Outcome
Title Duration of Confirmed A/H3N2 Vaccine Virus Shedding
Hide Description The number of days of shedding was summarized for all participants who shed confirmed A/H3N2 strain virus.
Time Frame Days 1-28 after study vaccination (up to Day 28)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 57 15
Mean (Standard Deviation)
Unit of Measure: days
1.8  (0.9) 1.7  (0.8)
8.Secondary Outcome
Title Duration of Confirmed B Vaccine Virus Shedding
Hide Description The number of days of shedding was summarized for all participants who shed confirmed B strain virus.
Time Frame Days 1-28 after study vaccination (up to Day 28)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 37 37
Mean (Standard Deviation)
Unit of Measure: days
2.1  (1.5) 1.8  (1.2)
9.Secondary Outcome
Title Quantitation of Confirmed A/H1N1 Shed Vaccine Virus on Any Day
Hide Description 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.
Time Frame Days 1-28 after study vaccination (up to Day 28)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 52 45
Mean (Standard Deviation)
Unit of Measure: log (TCID50)/mL
2.14  (0.98) 2.62  (0.97)
10.Secondary Outcome
Title Quantitation of Confirmed A/H3N2 Shed Vaccine Virus on Any Day
Hide Description 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.
Time Frame Days 1-28 after study vaccination (up to Day 28)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 24 5
Mean (Standard Deviation)
Unit of Measure: log (TCID50)/mL
1.59  (0.95) 1.10  (0.53)
11.Secondary Outcome
Title Quantitation of Confirmed B Shed Vaccine Virus on Any Day
Hide Description 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.
Time Frame Days 1-28 after study vaccination (up to Day 28)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 28 29
Mean (Standard Deviation)
Unit of Measure: log (TCID50)/mL
1.70  (1.09) 1.24  (0.68)
12.Secondary Outcome
Title Number of Participants With Genotypic and Phenotypic Stability of A/H1N1 Shed Vaccine Virus
Hide Description 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.
Time Frame Days 1-28 after study vaccination (up to Day 28)
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Hide Analysis Population Description
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.
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants between 6 to < 60 months age 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 Number of Participants Analyzed 93
Measure Type: Number
Unit of Measure: participants
Genotypic Stability (n=0) NA [1] 
Phenotypic Stability (n=93) 90
[1]
Data not available because no participant was evaluable for the specified category.
13.Secondary Outcome
Title Number of Participants With Genotypic and Phenotypic Stability of A/H3N2 Shed Vaccine Virus
Hide Description 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.
Time Frame Days 1-28 after study vaccination (up to Day 28)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants between 6 to < 60 months age 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 Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: participants
Genotypic Stability (n=0) NA [1] 
Phenotypic Stability (n=39) 37
[1]
Data not available because no participant was evaluable for the specified category.
14.Secondary Outcome
Title Number of Participants With Genotypic and Phenotypic Stability of B Shed Vaccine Virus
Hide Description 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.
Time Frame Days 1-28 after study vaccination (up to Day 28)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants between 6 to < 60 months age 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 Number of Participants Analyzed 61
Measure Type: Number
Unit of Measure: participants
Genotypic Stability (n=33) 33
Phenotypic Stability (n=61) 29
15.Secondary Outcome
Title Number of Participants With Reactogenicity Events (REs) and Adverse Events (AEs) Through 28 Days Post Vaccination
Hide Description 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.
Time Frame Days 0-28 after vaccination (up to Day 28)
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Hide Analysis Population Description
Safety population included all participants who received any study drug and had experienced any follow-up for safety.
Arm/Group Title Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 100 100
Measure Type: Number
Unit of Measure: participants
Any REs 84 77
AEs 48 31
16.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC) Through 180 Days Post Vaccination
Hide Description 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).
Time Frame Days 0-180 after vaccination (up to 6.5 months)
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Hide Analysis Population Description
Safety population included all participants who received any study drug and had experienced any follow-up for safety.
Arm/Group Title Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 100 100
Measure Type: Number
Unit of Measure: participants
SAEs 1 0
SNMC 1 1
17.Secondary Outcome
Title Number of Participants With REs in Relation to Any Vaccine Virus Shedding
Hide Description 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.
Time Frame Days 0-28 after study vaccination (up to Day 28)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 83 77
Measure Type: Number
Unit of Measure: participants
75 55
Time Frame AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
Hide Arm/Group Description 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). 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).
All-Cause Mortality
Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/100 (1.00%)      0/100 (0.00%)    
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  1/100 (1.00%)  1 0/100 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   48/100 (48.00%)      25/100 (25.00%)    
Ear and labyrinth disorders     
OTORRHOEA * 1  2/100 (2.00%)  2 0/100 (0.00%)  0
Eye disorders     
CONJUNCTIVITIS * 1  2/100 (2.00%)  2 0/100 (0.00%)  0
Gastrointestinal disorders     
DIARRHOEA * 1  5/100 (5.00%)  6 9/100 (9.00%)  11
FLATULENCE * 1  2/100 (2.00%)  4 0/100 (0.00%)  0
TEETHING * 1  21/100 (21.00%)  30 0/100 (0.00%)  0
Infections and infestations     
HERPANGINA * 1  2/100 (2.00%)  2 0/100 (0.00%)  0
OTITIS MEDIA * 1  4/100 (4.00%)  4 0/100 (0.00%)  0
PHARYNGITIS STREPTOCOCCAL * 1  1/100 (1.00%)  1 3/100 (3.00%)  3
VIRAL INFECTION * 1  3/100 (3.00%)  4 2/100 (2.00%)  2
Injury, poisoning and procedural complications     
ARTHROPOD BITE * 1  4/100 (4.00%)  4 3/100 (3.00%)  3
ARTHROPOD STING * 1  0/100 (0.00%)  0 2/100 (2.00%)  2
Investigations     
BODY TEMPERATURE INCREASED * 1  3/100 (3.00%)  4 2/100 (2.00%)  2
Respiratory, thoracic and mediastinal disorders     
EPISTAXIS * 1  3/100 (3.00%)  3 2/100 (2.00%)  2
Skin and subcutaneous tissue disorders     
ECZEMA * 1  2/100 (2.00%)  2 0/100 (0.00%)  0
HEAT RASH * 1  0/100 (0.00%)  0 2/100 (2.00%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Raburn Mallory MD/ Sr Dir Clinical Development
Organization: MedImmune, LLC
Phone: 301-398-0000
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00344305     History of Changes
Other Study ID Numbers: MI-CP129
First Submitted: June 22, 2006
First Posted: June 26, 2006
Results First Submitted: July 29, 2010
Results First Posted: November 1, 2010
Last Update Posted: July 24, 2017