Trial Outcomes & Findings for Safety Study to Evaluate FluMist in Immunocompromised Children (NCT NCT00112112)
NCT ID: NCT00112112
Last Updated: 2017-08-14
Results Overview
Reactogenicity events (REs) are predefined solicited adverse events (AEs) that can potentially occur after vaccine administration. The REs for this study included fever, runny nose/nasal congestion, sore throat, cough, vomiting, headache, muscle aches, chills, tiredness, and irritability.
COMPLETED
PHASE1
20 participants
0-42 days after study vaccination
2017-08-14
Participant Flow
A total of 20 participants, 10 in the FluMist group and 10 in the placebo group, were enrolled in the study between 08Aug2005 and 31Mar2008 at 4 sites in the USA.
A total of 20 participants were randomized in a 1:1 ratio to the FluMist or placebo group. Participants were enrolled on a staggered schedule to assess safety. Four participants were enrolled and treated in 2005, 8 in 2006, and 8 in 2007; each subset was assessed for vaccine-related serious adverse events prior to enrollment of the next subset.
Participant milestones
| Measure |
Placebo
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
FluMist
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study to Evaluate FluMist in Immunocompromised Children
Baseline characteristics by cohort
| Measure |
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
FluMist
n=10 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.2 Years
STANDARD_DEVIATION 3.8 • n=99 Participants
|
12.2 Years
STANDARD_DEVIATION 3.9 • n=107 Participants
|
12.2 Years
STANDARD_DEVIATION 3.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 0-42 days after study vaccinationPopulation: Participants who received any study vaccine and had any follow-up for REs and/or AEs. One participant in FluMist group did not have any RE data and was excluded from the RE analysis.
Reactogenicity events (REs) are predefined solicited adverse events (AEs) that can potentially occur after vaccine administration. The REs for this study included fever, runny nose/nasal congestion, sore throat, cough, vomiting, headache, muscle aches, chills, tiredness, and irritability.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Number of Participants Who Had Reactogenicity Events (REs)
|
8 participants
|
9 participants
|
PRIMARY outcome
Timeframe: 0-180 days after study vaccinationPopulation: Participants who received any study vaccine and had any follow-up for REs and/or AEs.
An SAE is any AE that results in any of the following outcomes: •Death • Life-threatening • Inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity • Congenital anomaly/birth defect (in the offspring of a study participant) • An important medical event that may may jeopardize the study participant and may require medical or surgical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
FluMist
n=10 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Number of Participants Who Had Serious Adverse Events (SAEs)
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 0-42 days after study vaccinationPopulation: Participants who received any study vaccine and had any follow-up for REs and/or AEs.
An AE is any untoward medical occurrence in a patient or clinical investigations study participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
FluMist
n=10 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Number of Participants Who Had Adverse Events (AEs)
|
6 participants
|
10 participants
|
PRIMARY outcome
Timeframe: 43-180 days after study vaccinationPopulation: Participants who received any study vaccine and had any follow-up for REs and/or AEs.
A significant new medical condition is defined as a new diagnosis of a chronic medical condition that does not meet the criteria of a SAE.
Outcome measures
| Measure |
FluMist
n=10 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Number of Significant New Medical Conditions (SNMCs)
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: 3-5 days after study vaccinationPopulation: Participants who received any study vaccine and had any follow-up for REs and/or AEs.
Number of participants with nasal swab samples that contained vaccine-like virus are reported.
Outcome measures
| Measure |
FluMist
n=10 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Number of Participants Shedding Vaccine-like Virus
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 7-10 days after study vaccinationPopulation: Participants who received any study vaccine and had any follow-up for REs and/or AEs.
Number of participants with nasal swab samples that contained vaccine-like virus are reported.
Outcome measures
| Measure |
FluMist
n=10 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Number of Participants Shedding Vaccine-like Virus
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 14-28 days after study vaccinationPopulation: Participants who received any study vaccine and had any follow-up for REs and/or AEs.
Number of participants with nasal swab samples that contained vaccine-like virus are reported.
Outcome measures
| Measure |
FluMist
n=10 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Number of Participants Shedding Vaccine-like Virus
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 35-42 days after study vaccinationPopulation: Participants who received any study vaccine and had any follow-up for REs and/or AEs.
Number of participants with nasal swab samples that contained vaccine-like virus are reported. Sample was collected at this time point only if health assessment indicated presence of a respiratory illness, including otitis media.
Outcome measures
| Measure |
FluMist
n=10 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Number of Participants Shedding Vaccine-like Virus
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Unscheduled visits occurring during 0-42 days after study vaccinationPopulation: Participants who received any study vaccine and had any follow-up for REs and/or AEs.
Number of participants with nasal swab samples that contained vaccine-like virus are reported.
Outcome measures
| Measure |
FluMist
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=4 participants w/unsched. illness visits
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Number of Participants Shedding Vaccine-like Virus
|
—
|
0 participants
|
SECONDARY outcome
Timeframe: pre-dosing (Day 0)Population: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
T- and B-lymphocyte Subsets by Flow Cytometry - Cluster of Differentiation (CD) 19
|
8.6 percentage of lymphocytes
Standard Deviation 7.4
|
4.8 percentage of lymphocytes
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: pre-dosing (Day 0)Population: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
T- and B-lymphocyte Subsets by Flow Cytometry - CD3
|
83.6 percentage of lymphocytes
Standard Deviation 8.9
|
89.1 percentage of lymphocytes
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: pre-dosing (Day 0)Population: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
T- and B-lymphocyte Subsets by Flow Cytometry - CD4
|
47.3 percentage of lymphocytes
Standard Deviation 9.8
|
46.7 percentage of lymphocytes
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: pre-dosing (Day 0)Population: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean and standard deviation results of CD8 lymphocyte subsets as a percentage of total lymphocytes.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
T- and B-lymphocyte Subsets by Flow Cytometry - CD8
|
31.4 percentage of lymphocytes
Standard Deviation 8.1
|
38.8 percentage of lymphocytes
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: 7-10 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=8 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
T- and B-lymphocyte Subsets by Flow Cytometry - CD19
|
10.2 percentage of lymphocytes
Standard Deviation 10.8
|
5.1 percentage of lymphocytes
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: 7-10 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=8 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
T- and B-lymphocyte Subsets by Flow Cytometry - CD3
|
82.0 percentage of lymphocytes
Standard Deviation 9.9
|
89.9 percentage of lymphocytes
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: 7-10 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=8 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
T- and B-lymphocyte Subsets by Flow Cytometry - CD4
|
48.2 percentage of lymphocytes
Standard Deviation 11.8
|
46.5 percentage of lymphocytes
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: 7-10 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean and standard deviation results of CD8 lymphocyte subsets as a percentage of total lymphocytes.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=8 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
T- and B-lymphocyte Subsets by Flow Cytometry - CD8
|
27.9 percentage of lymphocytes
Standard Deviation 8.0
|
39.6 percentage of lymphocytes
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: pre-dosing (Day 0)Population: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean and standard deviation spots-forming cells per 10\^5 T cells is reported.
Outcome measures
| Measure |
FluMist
n=7 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Interferon (INF)-Gamma
|
17.0 cells per 10^5 T cells
Standard Deviation 27.2
|
16.5 cells per 10^5 T cells
Standard Deviation 25.9
|
SECONDARY outcome
Timeframe: 7-10 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean and standard deviation spots-forming cells per 10\^5 T cells is reported.
Outcome measures
| Measure |
FluMist
n=7 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
INF-Gamma
|
28.6 cells per 10^5 T cells
Standard Deviation 43.7
|
7.5 cells per 10^5 T cells
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: 35-42 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean and standard deviation spots-forming cells per 10\^5 T cells is reported.
Outcome measures
| Measure |
FluMist
n=7 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
INF-Gamma
|
28.0 cells per 10^5 T cells
Standard Deviation 38.7
|
16.6 cells per 10^5 T cells
Standard Deviation 27.0
|
SECONDARY outcome
Timeframe: pre-dosing (Day 0)Population: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean and standard deviation spots-forming cells per 10\^5 T cells is reported.
Outcome measures
| Measure |
FluMist
n=8 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Interleukin (IL)-4
|
2.6 cells per 10^5 T cells
Standard Deviation 4.3
|
5.5 cells per 10^5 T cells
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: 7-10 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean and standard deviation spots-forming cells per 10\^5 T cells is reported.
Outcome measures
| Measure |
FluMist
n=8 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
IL-4
|
1.9 cells per 10^5 T cells
Standard Deviation 2.7
|
2.6 cells per 10^5 T cells
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: 35-42 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean and standard deviation spots-forming cells per 10\^5 T cells is reported.
Outcome measures
| Measure |
FluMist
n=8 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
IL-4
|
2.9 cells per 10^5 T cells
Standard Deviation 3.9
|
4.7 cells per 10^5 T cells
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: pre-dosing (Day 0)Population: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.
Outcome measures
| Measure |
FluMist
n=6 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=5 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Human Leukocyte Antigen (HLA) Matched Tetramers CD8+
|
11.045 Percentage of lymphocytes
Standard Deviation 6.452
|
12.778 Percentage of lymphocytes
Standard Deviation 6.579
|
SECONDARY outcome
Timeframe: 7-10 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.
Outcome measures
| Measure |
FluMist
n=6 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=5 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
HLA Matched Tetramers CD8+
|
8.048 Percentage of lymphocytes
Standard Deviation 6.701
|
8.632 Percentage of lymphocytes
Standard Deviation 4.126
|
SECONDARY outcome
Timeframe: 35-42 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.
Outcome measures
| Measure |
FluMist
n=6 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=5 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
HLA Matched Tetramers CD8+
|
7.997 Percentage of lymphocytes
Standard Deviation 3.143
|
12.922 Percentage of lymphocytes
Standard Deviation 8.607
|
SECONDARY outcome
Timeframe: Baseline (pre-dosing on Day 0) and 35-42 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.
Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers \>= 4 from baseline are reported.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza A/H1N1 Hemagglutination Inhibition (HAI) Titers From Baseline to Day 35-42
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline (pre-dosing on Day 0) and 35-42 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.
Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers \>= 4 from baseline are reported.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza A/H3N2 HAI Titers From Baseline to Day 35-42
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline (pre-dosing on Day 0) and 35-42 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.
Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers \>= 4 from baseline are reported.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza B HAI Titers From Baseline to Day 35-42
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline (pre-dosing on Day 0) and 35-42 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.
Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers \>= 4 from baseline are reported.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Number of Participants Who Experienced a >= 4-fold Rise in Influenza A/H1N1 Microneutralization Titers From Baseline to Day 35-42
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline (pre-dosing on Day 0) and 35-42 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.
Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers \>= 4 from baseline are reported.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Number of Participants Who Experienced a >= 4-fold Rise in Influenza A/H3N2 Microneutralization Titers From Baseline to Day 35-42
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline (pre-dosing on Day 0) and 35-42 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.
Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers \>= 4 from baseline are reported.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Number of Participants Who Experienced a >= 4-fold Rise in Influenza B Microneutralization Titers From Baseline to Day 35-42
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: pre-dosing (Day 0)Population: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza A/H1N1 Immunoglobulin A (IgA)
|
0.8 titer
Standard Deviation 0.8
|
0.5 titer
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: 3-5 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza A/H1N1 IgA
|
0.8 titer
Standard Deviation 0.7
|
0.5 titer
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: 7-10 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza A/H1N1 IgA
|
1.1 titer
Standard Deviation 1.1
|
0.5 titer
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: 14-28 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza A/H1N1 IgA
|
0.9 titer
Standard Deviation 0.9
|
1.1 titer
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 35-42 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza A/H1N1 IgA
|
1.3 titer
Standard Deviation 1.3
|
0.5 titer
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: pre-dosing (Day 0)Population: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza A/H3N2 IgA
|
1.0 titer
Standard Deviation 0.8
|
0.7 titer
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 3-5 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza A/H3N2 IgA
|
0.7 titer
Standard Deviation 0.5
|
0.5 titer
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: 7-10 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza A/H3N2 IgA
|
1.2 titer
Standard Deviation 0.8
|
0.7 titer
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 14-28 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza A/H3N2 IgA
|
0.7 titer
Standard Deviation 0.5
|
1.1 titer
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 35-42 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza A/H3N2 IgA
|
1.7 titer
Standard Deviation 1.0
|
0.5 titer
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: pre-dosing (Day 0)Population: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza B IgA
|
0.5 titer
Standard Deviation 0.0
|
0.5 titer
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: 3-5 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza B IgA
|
0.5 titer
Standard Deviation 0.0
|
0.5 titer
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: 7-10 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza B IgA
|
0.5 titer
Standard Deviation 0.0
|
0.5 titer
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: 14-28 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza B IgA
|
0.5 titer
Standard Deviation 0.0
|
0.5 titer
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: 35-42 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza B IgA
|
0.7 titer
Standard Deviation 0.5
|
0.5 titer
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: pre-dosing (Day 0)Population: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean and standard deviation results of CD56 lymphocyte subsets is reported.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
T- and B-lymphocyte Subsets by Flow Cytometry - CD56
|
7.6 percent of lymphocytes
Standard Deviation 5.5
|
5.2 percent of lymphocytes
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 7-10 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean and standard deviation results of CD56 lymphocyte subsets is reported.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=8 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
T- and B-lymphocyte Subsets by Flow Cytometry - CD56
|
6.6 percent of lymphocytes
Standard Deviation 5.6
|
4.6 percent of lymphocytes
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: pre-dosing (Day 0)Population: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean and standard deviation results of white blood cells subsets is reported.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells
|
3.91 cells per 10^3/UL
Standard Deviation 1.56
|
4.19 cells per 10^3/UL
Standard Deviation 1.49
|
SECONDARY outcome
Timeframe: 7-10 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean and standard deviation results of white blood cells subsets is reported.
Outcome measures
| Measure |
FluMist
n=8 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=9 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells
|
4.05 cells per 10^3/UL
Standard Deviation 1.33
|
3.24 cells per 10^3/UL
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: pre-dosing (Day 0)Population: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean and standard deviation results of lymphocytes subsets is reported.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes
|
27.56 Percentage of lymphocytes
Standard Deviation 9.25
|
17.62 Percentage of lymphocytes
Standard Deviation 7.56
|
SECONDARY outcome
Timeframe: 7-10 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean and standard deviation results of lymphocytes subsets is reported.
Outcome measures
| Measure |
FluMist
n=8 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=9 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes
|
23.13 Percentage of lymphocytes
Standard Deviation 8.23
|
22.58 Percentage of lymphocytes
Standard Deviation 11.89
|
SECONDARY outcome
Timeframe: pre-dosing (Day 0)Population: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean and standard deviation results of absolute lymphocytes subsets is reported.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes
|
1.03 Cells per 10^3/UL
Standard Deviation 0.50
|
0.77 Cells per 10^3/UL
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: 7-10 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean and standard deviation results of absolute lymphocytes subsets is reported.
Outcome measures
| Measure |
FluMist
n=8 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=9 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes
|
0.98 Cells per 10^3/UL
Standard Deviation 0.57
|
0.77 Cells per 10^3/UL
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: pre-dosing (Day 0)Population: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean and standard deviation results of absolute neutrophils subsets is reported.
Outcome measures
| Measure |
FluMist
n=7 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=5 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Neutrophils
|
2728.6 Cells per 10^3/UL
Standard Deviation 1162.9
|
3300.0 Cells per 10^3/UL
Standard Deviation 1534.6
|
SECONDARY outcome
Timeframe: pre-dosing (Day 0)Population: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgG from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza A/H1N1 Immunoglobulin G (IgG)
|
672.4 titer
Standard Deviation 492.8
|
954.7 titer
Standard Deviation 1245.3
|
SECONDARY outcome
Timeframe: 35-42 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgG from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza A/H1N1 IgG
|
844.0 titer
Standard Deviation 645.7
|
924.3 titer
Standard Deviation 1207.2
|
SECONDARY outcome
Timeframe: pre-dosing (Day 0)Population: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgG from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza A/H3N2 IgG
|
1842.4 titer
Standard Deviation 1989.1
|
799.1 titer
Standard Deviation 426.2
|
SECONDARY outcome
Timeframe: 35-42 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgG from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza A/H3N2 IgG
|
1671.9 titer
Standard Deviation 1646.6
|
742.9 titer
Standard Deviation 432.2
|
SECONDARY outcome
Timeframe: pre-dosing (Day 0)Population: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgG from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza B IgG
|
638.6 titer
Standard Deviation 334.5
|
599.1 titer
Standard Deviation 344.2
|
SECONDARY outcome
Timeframe: 35-42 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgG from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza B IgG
|
1020.3 titer
Standard Deviation 715.6
|
620.2 titer
Standard Deviation 472.8
|
SECONDARY outcome
Timeframe: pre-dosing (Day 0)Population: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgM from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza A/H1N1 Immunoglobulin M (IgM)
|
160.4 titer
Standard Deviation 105.4
|
150.1 titer
Standard Deviation 107.0
|
SECONDARY outcome
Timeframe: 35-42 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgM from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza A/H1N1 IgM
|
134.8 titer
Standard Deviation 100.7
|
171.3 titer
Standard Deviation 106.7
|
SECONDARY outcome
Timeframe: pre-dosing (Day 0)Population: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgM from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza A/H3N2 IgM
|
134.7 titer
Standard Deviation 100.4
|
153.1 titer
Standard Deviation 109.4
|
SECONDARY outcome
Timeframe: 35-42 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgM from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza A/H3N2 IgM
|
136.9 titer
Standard Deviation 103.1
|
189.9 titer
Standard Deviation 98.5
|
SECONDARY outcome
Timeframe: pre-dosing (Day 0)Population: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgM from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza B IgM
|
72.2 titer
Standard Deviation 66.7
|
69.3 titer
Standard Deviation 61.0
|
SECONDARY outcome
Timeframe: 35-42 days after study vaccinationPopulation: All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.
Mean of influenza-specific IgM from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Outcome measures
| Measure |
FluMist
n=9 Participants
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
Placebo
n=10 Participants
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
|---|---|---|
|
Influenza B IgM
|
68.4 titer
Standard Deviation 55.3
|
82.0 titer
Standard Deviation 69.7
|
Adverse Events
Placebo
FluMist
Serious adverse events
| Measure |
Placebo
n=10 participants at risk
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
FluMist
n=10 participants at risk
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Infections and infestations
Bacteraemia
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Infections and infestations
Herpes zoster
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
Other adverse events
| Measure |
Placebo
n=10 participants at risk
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
|
FluMist
n=10 participants at risk
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Eye disorders
Conjunctivitis
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Gastrointestinal disorders
Oral pain
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Infections and infestations
Fungal skin infection
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Metabolism and nutrition disorders
Oral intake reduced
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
10.0%
1/10 • Number of events 2 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
|
Skin and subcutaneous tissue disorders
Skin chapped
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
0.00%
0/10 • Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.
|
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 ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.The principal investigators (PIs) also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER