Cancer
Conditions
Keywords
cancer, pediatric, influenza, vaccine
Brief summary
The main purpose of this study is to get information about the safety of a flu vaccine spray, called FluMist, in children with cancer. The study is also being done to find out how much and how long the vaccine spray can be found in the nose.
Detailed description
This study is a randomized, double-blind Phase 1 study of FluMist vs. placebo in mild to moderately immunocompromised children 5 to 17 years of age with cancer. The primary objective of this study is to describe the safety of FluMist compared with placebo in mild to moderately immunocompromised children with cancer. The secondary objectives of this study are to describe the immune responses following vaccination with FluMist and to determine the incidence and duration of viral replication following vaccination with FluMist. The standard 0.5 mL dose of vaccine or placebo was administered intranasally. Patients were evaluated at four visits scheduled between days 3-5, days 7-10, days 14-28, and days 35-42 for viral shedding via nasal swabs. Safety outcomes were collected at study clinic visits or by telephone contact through 42 days post dose. Serious adverse events and significant new medical conditions were collected through 180 days after receipt of investigational product. Immune responses were measured by detection of influenza-specific antibodies as measured by the standard hemagglutination inhibition (HAI) assay. Influenza-specific serum antibody isotype levels were determined and nasal swab specimens were analyzed for the expression of influenza-specific immunoglobulin A (IgA). Serum was analyzed for its ability to neutralize viral particles from infecting Madin-Darby canine kidney cells (microneutralization). Baseline immunosuppression as measured by expression of T- and B-lymphocyte subsets was compared to immunosuppression at time points after vaccination. The duration of viral replication and the titers of live-attenuated influenza virus shed was evaluated from nasal swab specimens collected at scheduled time points after administration of FluMist.
Interventions
BIOLOGICALFluMist
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 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains. During the 2005 enrollment period, the three 2004/2005 influenza virus strains were used: A/New Caledonia/20/99(H1N1), A/Wyoming/03/2003(H3N2), and B/Jilin/20/2003). During the 2006 and 2007 enrollment periods, the three 2005/2006 influenza virus strains were used: A/New Caledonia/20/99(H1N1), A/California/7/2004(H3N2), and B/Jiangsu/10/2003 (B/Shanghai/361/2002-like. brief description of the arm. This element may not be necessary if the associated intervention descriptions contain sufficient information to describe the arm.
BIOLOGICALPlacebo
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).
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age 5 through 17 years of age (not yet reached their 18th birthday) at the time of entry into the study; * Patient's parent or legal guardian available by telephone during the course of the study; * Written informed consent (assent if applicable) and Health Insurance Portability and Accountability Act (HIPAA) authorization (if applicable) obtained from the patient's parent or legal guardian; * Ability of the patient or patient's parent/guardian to comply with the requirements of the protocol; * Currently receiving chemotherapy and/or radiation therapy for the treatment of cancer or have received chemotherapy in the past 12 weeks; * If the subject's underlying cancer is a solid tumor, current status must be stable disease, partial response, or complete response to therapy; if the subject's underlying disease is a hematologic malignancy, current status must be in remission; * Estimated life expectancy of \>1 year; and * Currently has no worse than mild to moderate immunosuppression (meets none of the
Exclusion criteria
).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had Reactogenicity Events (REs) | 0-42 days after study vaccination | 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. |
| Number of Participants Who Had Serious Adverse Events (SAEs) | 0-180 days after study vaccination | 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. |
| Number of Participants Who Had Adverse Events (AEs) | 0-42 days after study vaccination | 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. |
| Number of Significant New Medical Conditions (SNMCs) | 43-180 days after study vaccination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| T- and B-lymphocyte Subsets by Flow Cytometry - CD8 | pre-dosing (Day 0) | Mean and standard deviation results of CD8 lymphocyte subsets as a percentage of total lymphocytes. |
| T- and B-lymphocyte Subsets by Flow Cytometry - CD19 | 7-10 days after study vaccination | Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes. |
| Interferon (INF)-Gamma | pre-dosing (Day 0) | Mean and standard deviation spots-forming cells per 10\^5 T cells is reported. |
| INF-Gamma | 7-10 days after study vaccination | Mean and standard deviation spots-forming cells per 10\^5 T cells is reported. |
| Interleukin (IL)-4 | pre-dosing (Day 0) | Mean and standard deviation spots-forming cells per 10\^5 T cells is reported. |
| IL-4 | 7-10 days after study vaccination | Mean and standard deviation spots-forming cells per 10\^5 T cells is reported. |
| Human Leukocyte Antigen (HLA) Matched Tetramers CD8+ | pre-dosing (Day 0) | The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations. |
| HLA Matched Tetramers CD8+ | 7-10 days after study vaccination | The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations. |
| Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza A/H1N1 Hemagglutination Inhibition (HAI) Titers From Baseline to Day 35-42 | Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination | Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers \>= 4 from baseline are reported. |
| Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza A/H3N2 HAI Titers From Baseline to Day 35-42 | Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination | Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers \>= 4 from baseline are reported. |
| Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza B HAI Titers From Baseline to Day 35-42 | Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination | Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers \>= 4 from baseline are reported. |
| Number of Participants Who Experienced a >= 4-fold Rise in Influenza A/H1N1 Microneutralization Titers From Baseline to Day 35-42 | Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination | Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers \>= 4 from baseline are reported. |
| Number of Participants Who Experienced a >= 4-fold Rise in Influenza A/H3N2 Microneutralization Titers From Baseline to Day 35-42 | Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination | Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers \>= 4 from baseline are reported. |
| Number of Participants Who Experienced a >= 4-fold Rise in Influenza B Microneutralization Titers From Baseline to Day 35-42 | Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination | Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers \>= 4 from baseline are reported. |
| Influenza A/H1N1 Immunoglobulin A (IgA) | pre-dosing (Day 0) | Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5. |
| Number of Participants Shedding Vaccine-like Virus | 3-5 days after study vaccination | Number of participants with nasal swab samples that contained vaccine-like virus are reported. |
| Influenza A/H3N2 IgA | pre-dosing (Day 0) | Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5. |
| Influenza B IgA | pre-dosing (Day 0) | Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5. |
| T- and B-lymphocyte Subsets by Flow Cytometry - CD56 | pre-dosing (Day 0) | Mean and standard deviation results of CD56 lymphocyte subsets is reported. |
| T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells | pre-dosing (Day 0) | Mean and standard deviation results of white blood cells subsets is reported. |
| T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes | pre-dosing (Day 0) | Mean and standard deviation results of lymphocytes subsets is reported. |
| T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes | pre-dosing (Day 0) | Mean and standard deviation results of absolute lymphocytes subsets is reported. |
| T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Neutrophils | pre-dosing (Day 0) | Mean and standard deviation results of absolute neutrophils subsets is reported. |
| Influenza A/H1N1 Immunoglobulin G (IgG) | pre-dosing (Day 0) | Mean of influenza-specific IgG from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5. |
| Influenza A/H1N1 IgG | 35-42 days after study vaccination | Mean of influenza-specific IgG from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5. |
| Influenza A/H3N2 IgG | pre-dosing (Day 0) | Mean of influenza-specific IgG from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5. |
| Influenza B IgG | pre-dosing (Day 0) | Mean of influenza-specific IgG from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5. |
| Influenza A/H1N1 Immunoglobulin M (IgM) | pre-dosing (Day 0) | Mean of influenza-specific IgM from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5. |
| Influenza A/H1N1 IgM | 35-42 days after study vaccination | Mean of influenza-specific IgM from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5. |
| Influenza A/H3N2 IgM | pre-dosing (Day 0) | Mean of influenza-specific IgM from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5. |
| Influenza B IgM | pre-dosing (Day 0) | Mean of influenza-specific IgM from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5. |
| Influenza A/H1N1 IgA | 3-5 days after study vaccination | Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5. |
| T- and B-lymphocyte Subsets by Flow Cytometry - Cluster of Differentiation (CD) 19 | pre-dosing (Day 0) | Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes. |
| T- and B-lymphocyte Subsets by Flow Cytometry - CD3 | pre-dosing (Day 0) | Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes. |
| T- and B-lymphocyte Subsets by Flow Cytometry - CD4 | pre-dosing (Day 0) | Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 10 |
| 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. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Placebo | FluMist | Total |
|---|---|---|---|
| Age, Continuous | 12.2 Years STANDARD_DEVIATION 3.8 | 12.2 Years STANDARD_DEVIATION 3.9 | 12.2 Years STANDARD_DEVIATION 3.8 |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 11 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 10 | 5 / 10 |
| serious Total, serious adverse events | 3 / 10 | 1 / 10 |
Outcome results
Primary
Number of Participants Who Had Adverse Events (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.
Time frame: 0-42 days after study vaccination
Population: Participants who received any study vaccine and had any follow-up for REs and/or AEs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist | Number of Participants Who Had Adverse Events (AEs) | 6 participants |
| Placebo | Number of Participants Who Had Adverse Events (AEs) | 10 participants |
Primary
Number of Participants Who Had Reactogenicity Events (REs)
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.
Time frame: 0-42 days after study vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist | Number of Participants Who Had Reactogenicity Events (REs) | 8 participants |
| Placebo | Number of Participants Who Had Reactogenicity Events (REs) | 9 participants |
Primary
Number of Participants Who Had Serious Adverse Events (SAEs)
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.
Time frame: 0-180 days after study vaccination
Population: Participants who received any study vaccine and had any follow-up for REs and/or AEs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist | Number of Participants Who Had Serious Adverse Events (SAEs) | 1 Participants |
| Placebo | Number of Participants Who Had Serious Adverse Events (SAEs) | 3 Participants |
Primary
Number of Significant New Medical Conditions (SNMCs)
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.
Time frame: 43-180 days after study vaccination
Population: Participants who received any study vaccine and had any follow-up for REs and/or AEs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist | Number of Significant New Medical Conditions (SNMCs) | 0 events |
| Placebo | Number of Significant New Medical Conditions (SNMCs) | 0 events |
Secondary
HLA Matched Tetramers CD8+
The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.
Time frame: 35-42 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | HLA Matched Tetramers CD8+ | 7.997 Percentage of lymphocytes | Standard Deviation 3.143 |
| Placebo | HLA Matched Tetramers CD8+ | 12.922 Percentage of lymphocytes | Standard Deviation 8.607 |
Secondary
HLA Matched Tetramers CD8+
The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.
Time frame: 7-10 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | HLA Matched Tetramers CD8+ | 8.048 Percentage of lymphocytes | Standard Deviation 6.701 |
| Placebo | HLA Matched Tetramers CD8+ | 8.632 Percentage of lymphocytes | Standard Deviation 4.126 |
Secondary
Human Leukocyte Antigen (HLA) Matched Tetramers CD8+
The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Human Leukocyte Antigen (HLA) Matched Tetramers CD8+ | 11.045 Percentage of lymphocytes | Standard Deviation 6.452 |
| Placebo | Human Leukocyte Antigen (HLA) Matched Tetramers CD8+ | 12.778 Percentage of lymphocytes | Standard Deviation 6.579 |
Secondary
IL-4
Mean and standard deviation spots-forming cells per 10\^5 T cells is reported.
Time frame: 35-42 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | IL-4 | 2.9 cells per 10^5 T cells | Standard Deviation 3.9 |
| Placebo | IL-4 | 4.7 cells per 10^5 T cells | Standard Deviation 6.1 |
Secondary
IL-4
Mean and standard deviation spots-forming cells per 10\^5 T cells is reported.
Time frame: 7-10 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | IL-4 | 1.9 cells per 10^5 T cells | Standard Deviation 2.7 |
| Placebo | IL-4 | 2.6 cells per 10^5 T cells | Standard Deviation 3.5 |
Secondary
INF-Gamma
Mean and standard deviation spots-forming cells per 10\^5 T cells is reported.
Time frame: 35-42 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | INF-Gamma | 28.0 cells per 10^5 T cells | Standard Deviation 38.7 |
| Placebo | INF-Gamma | 16.6 cells per 10^5 T cells | Standard Deviation 27 |
Secondary
INF-Gamma
Mean and standard deviation spots-forming cells per 10\^5 T cells is reported.
Time frame: 7-10 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | INF-Gamma | 28.6 cells per 10^5 T cells | Standard Deviation 43.7 |
| Placebo | INF-Gamma | 7.5 cells per 10^5 T cells | Standard Deviation 7.6 |
Secondary
Influenza A/H1N1 IgA
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 7-10 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza A/H1N1 IgA | 1.1 titer | Standard Deviation 1.1 |
| Placebo | Influenza A/H1N1 IgA | 0.5 titer | Standard Deviation 0 |
Secondary
Influenza A/H1N1 IgA
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 35-42 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza A/H1N1 IgA | 1.3 titer | Standard Deviation 1.3 |
| Placebo | Influenza A/H1N1 IgA | 0.5 titer | Standard Deviation 0 |
Secondary
Influenza A/H1N1 IgA
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 14-28 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza A/H1N1 IgA | 0.9 titer | Standard Deviation 0.9 |
| Placebo | Influenza A/H1N1 IgA | 1.1 titer | Standard Deviation 1.3 |
Secondary
Influenza A/H1N1 IgA
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 3-5 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza A/H1N1 IgA | 0.8 titer | Standard Deviation 0.7 |
| Placebo | Influenza A/H1N1 IgA | 0.5 titer | Standard Deviation 0 |
Secondary
Influenza A/H1N1 IgG
Mean of influenza-specific IgG from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 35-42 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza A/H1N1 IgG | 844.0 titer | Standard Deviation 645.7 |
| Placebo | Influenza A/H1N1 IgG | 924.3 titer | Standard Deviation 1207.2 |
Secondary
Influenza A/H1N1 IgM
Mean of influenza-specific IgM from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 35-42 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza A/H1N1 IgM | 134.8 titer | Standard Deviation 100.7 |
| Placebo | Influenza A/H1N1 IgM | 171.3 titer | Standard Deviation 106.7 |
Secondary
Influenza A/H1N1 Immunoglobulin A (IgA)
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza A/H1N1 Immunoglobulin A (IgA) | 0.8 titer | Standard Deviation 0.8 |
| Placebo | Influenza A/H1N1 Immunoglobulin A (IgA) | 0.5 titer | Standard Deviation 0 |
Secondary
Influenza A/H1N1 Immunoglobulin G (IgG)
Mean of influenza-specific IgG from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza A/H1N1 Immunoglobulin G (IgG) | 672.4 titer | Standard Deviation 492.8 |
| Placebo | Influenza A/H1N1 Immunoglobulin G (IgG) | 954.7 titer | Standard Deviation 1245.3 |
Secondary
Influenza A/H1N1 Immunoglobulin M (IgM)
Mean of influenza-specific IgM from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza A/H1N1 Immunoglobulin M (IgM) | 160.4 titer | Standard Deviation 105.4 |
| Placebo | Influenza A/H1N1 Immunoglobulin M (IgM) | 150.1 titer | Standard Deviation 107 |
Secondary
Influenza A/H3N2 IgA
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 3-5 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza A/H3N2 IgA | 0.7 titer | Standard Deviation 0.5 |
| Placebo | Influenza A/H3N2 IgA | 0.5 titer | Standard Deviation 0 |
Secondary
Influenza A/H3N2 IgA
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 7-10 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza A/H3N2 IgA | 1.2 titer | Standard Deviation 0.8 |
| Placebo | Influenza A/H3N2 IgA | 0.7 titer | Standard Deviation 0.5 |
Secondary
Influenza A/H3N2 IgA
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza A/H3N2 IgA | 1.0 titer | Standard Deviation 0.8 |
| Placebo | Influenza A/H3N2 IgA | 0.7 titer | Standard Deviation 0.5 |
Secondary
Influenza A/H3N2 IgA
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 35-42 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza A/H3N2 IgA | 1.7 titer | Standard Deviation 1 |
| Placebo | Influenza A/H3N2 IgA | 0.5 titer | Standard Deviation 0 |
Secondary
Influenza A/H3N2 IgA
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 14-28 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza A/H3N2 IgA | 0.7 titer | Standard Deviation 0.5 |
| Placebo | Influenza A/H3N2 IgA | 1.1 titer | Standard Deviation 0.9 |
Secondary
Influenza A/H3N2 IgG
Mean of influenza-specific IgG from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza A/H3N2 IgG | 1842.4 titer | Standard Deviation 1989.1 |
| Placebo | Influenza A/H3N2 IgG | 799.1 titer | Standard Deviation 426.2 |
Secondary
Influenza A/H3N2 IgG
Mean of influenza-specific IgG from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 35-42 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza A/H3N2 IgG | 1671.9 titer | Standard Deviation 1646.6 |
| Placebo | Influenza A/H3N2 IgG | 742.9 titer | Standard Deviation 432.2 |
Secondary
Influenza A/H3N2 IgM
Mean of influenza-specific IgM from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 35-42 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza A/H3N2 IgM | 136.9 titer | Standard Deviation 103.1 |
| Placebo | Influenza A/H3N2 IgM | 189.9 titer | Standard Deviation 98.5 |
Secondary
Influenza A/H3N2 IgM
Mean of influenza-specific IgM from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza A/H3N2 IgM | 134.7 titer | Standard Deviation 100.4 |
| Placebo | Influenza A/H3N2 IgM | 153.1 titer | Standard Deviation 109.4 |
Secondary
Influenza B IgA
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 7-10 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza B IgA | 0.5 titer | Standard Deviation 0 |
| Placebo | Influenza B IgA | 0.5 titer | Standard Deviation 0 |
Secondary
Influenza B IgA
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza B IgA | 0.5 titer | Standard Deviation 0 |
| Placebo | Influenza B IgA | 0.5 titer | Standard Deviation 0 |
Secondary
Influenza B IgA
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 14-28 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza B IgA | 0.5 titer | Standard Deviation 0 |
| Placebo | Influenza B IgA | 0.5 titer | Standard Deviation 0 |
Secondary
Influenza B IgA
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 35-42 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza B IgA | 0.7 titer | Standard Deviation 0.5 |
| Placebo | Influenza B IgA | 0.5 titer | Standard Deviation 0 |
Secondary
Influenza B IgA
Mean of influenza-specific IgA from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 3-5 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza B IgA | 0.5 titer | Standard Deviation 0 |
| Placebo | Influenza B IgA | 0.5 titer | Standard Deviation 0 |
Secondary
Influenza B IgG
Mean of influenza-specific IgG from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 35-42 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza B IgG | 1020.3 titer | Standard Deviation 715.6 |
| Placebo | Influenza B IgG | 620.2 titer | Standard Deviation 472.8 |
Secondary
Influenza B IgG
Mean of influenza-specific IgG from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza B IgG | 638.6 titer | Standard Deviation 334.5 |
| Placebo | Influenza B IgG | 599.1 titer | Standard Deviation 344.2 |
Secondary
Influenza B IgM
Mean of influenza-specific IgM from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 35-42 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza B IgM | 68.4 titer | Standard Deviation 55.3 |
| Placebo | Influenza B IgM | 82.0 titer | Standard Deviation 69.7 |
Secondary
Influenza B IgM
Mean of influenza-specific IgM from nasal swab is reported. Titers of \< 1 were assigned the value of 0.5.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Influenza B IgM | 72.2 titer | Standard Deviation 66.7 |
| Placebo | Influenza B IgM | 69.3 titer | Standard Deviation 61 |
Secondary
Interferon (INF)-Gamma
Mean and standard deviation spots-forming cells per 10\^5 T cells is reported.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Interferon (INF)-Gamma | 17.0 cells per 10^5 T cells | Standard Deviation 27.2 |
| Placebo | Interferon (INF)-Gamma | 16.5 cells per 10^5 T cells | Standard Deviation 25.9 |
Secondary
Interleukin (IL)-4
Mean and standard deviation spots-forming cells per 10\^5 T cells is reported.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | Interleukin (IL)-4 | 2.6 cells per 10^5 T cells | Standard Deviation 4.3 |
| Placebo | Interleukin (IL)-4 | 5.5 cells per 10^5 T cells | Standard Deviation 8.4 |
Secondary
Number of Participants Shedding Vaccine-like Virus
Number of participants with nasal swab samples that contained vaccine-like virus are reported.
Time frame: 7-10 days after study vaccination
Population: Participants who received any study vaccine and had any follow-up for REs and/or AEs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist | Number of Participants Shedding Vaccine-like Virus | 2 participants |
| Placebo | Number of Participants Shedding Vaccine-like Virus | 0 participants |
Secondary
Number of Participants Shedding Vaccine-like Virus
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.
Time frame: 35-42 days after study vaccination
Population: Participants who received any study vaccine and had any follow-up for REs and/or AEs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist | Number of Participants Shedding Vaccine-like Virus | 0 participants |
| Placebo | Number of Participants Shedding Vaccine-like Virus | 0 participants |
Secondary
Number of Participants Shedding Vaccine-like Virus
Number of participants with nasal swab samples that contained vaccine-like virus are reported.
Time frame: 3-5 days after study vaccination
Population: Participants who received any study vaccine and had any follow-up for REs and/or AEs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist | Number of Participants Shedding Vaccine-like Virus | 3 participants |
| Placebo | Number of Participants Shedding Vaccine-like Virus | 0 participants |
Secondary
Number of Participants Shedding Vaccine-like Virus
Number of participants with nasal swab samples that contained vaccine-like virus are reported.
Time frame: 14-28 days after study vaccination
Population: Participants who received any study vaccine and had any follow-up for REs and/or AEs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist | Number of Participants Shedding Vaccine-like Virus | 0 participants |
| Placebo | Number of Participants Shedding Vaccine-like Virus | 0 participants |
Secondary
Number of Participants Shedding Vaccine-like Virus
Number of participants with nasal swab samples that contained vaccine-like virus are reported.
Time frame: Unscheduled visits occurring during 0-42 days after study vaccination
Population: Participants who received any study vaccine and had any follow-up for REs and/or AEs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Shedding Vaccine-like Virus | 0 participants |
Secondary
Number of Participants Who Experienced a >= 4-fold Rise in Influenza A/H1N1 Microneutralization Titers From Baseline to Day 35-42
Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers \>= 4 from baseline are reported.
Time frame: Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination
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 samples available for the specified days were analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist | Number of Participants Who Experienced a >= 4-fold Rise in Influenza A/H1N1 Microneutralization Titers From Baseline to Day 35-42 | 2 participants |
| Placebo | Number of Participants Who Experienced a >= 4-fold Rise in Influenza A/H1N1 Microneutralization Titers From Baseline to Day 35-42 | 0 participants |
Secondary
Number of Participants Who Experienced a >= 4-fold Rise in Influenza A/H3N2 Microneutralization Titers From Baseline to Day 35-42
Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers \>= 4 from baseline are reported.
Time frame: Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination
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 samples available for the specified days were analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist | Number of Participants Who Experienced a >= 4-fold Rise in Influenza A/H3N2 Microneutralization Titers From Baseline to Day 35-42 | 2 participants |
| Placebo | Number of Participants Who Experienced a >= 4-fold Rise in Influenza A/H3N2 Microneutralization Titers From Baseline to Day 35-42 | 0 participants |
Secondary
Number of Participants Who Experienced a >= 4-fold Rise in Influenza B Microneutralization Titers From Baseline to Day 35-42
Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers \>= 4 from baseline are reported.
Time frame: Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination
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 samples available for the specified days were analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist | Number of Participants Who Experienced a >= 4-fold Rise in Influenza B Microneutralization Titers From Baseline to Day 35-42 | 1 participants |
| Placebo | Number of Participants Who Experienced a >= 4-fold Rise in Influenza B Microneutralization Titers From Baseline to Day 35-42 | 0 participants |
Secondary
Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza A/H1N1 Hemagglutination Inhibition (HAI) Titers From Baseline to Day 35-42
Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers \>= 4 from baseline are reported.
Time frame: Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination
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 samples available for the specified days were analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist | 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 |
| Placebo | Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza A/H1N1 Hemagglutination Inhibition (HAI) Titers From Baseline to Day 35-42 | 0 participants |
Secondary
Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza A/H3N2 HAI Titers From Baseline to Day 35-42
Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers \>= 4 from baseline are reported.
Time frame: Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination
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 samples available for the specified days were analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist | Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza A/H3N2 HAI Titers From Baseline to Day 35-42 | 2 participants |
| Placebo | Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza A/H3N2 HAI Titers From Baseline to Day 35-42 | 0 participants |
Secondary
Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza B HAI Titers From Baseline to Day 35-42
Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers \>= 4 from baseline are reported.
Time frame: Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination
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 samples available for the specified days were analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FluMist | Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza B HAI Titers From Baseline to Day 35-42 | 1 participants |
| Placebo | Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza B HAI Titers From Baseline to Day 35-42 | 0 participants |
Secondary
T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes
Mean and standard deviation results of absolute lymphocytes subsets is reported.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes | 1.03 Cells per 10^3/UL | Standard Deviation 0.5 |
| Placebo | T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes | 0.77 Cells per 10^3/UL | Standard Deviation 0.51 |
Secondary
T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes
Mean and standard deviation results of absolute lymphocytes subsets is reported.
Time frame: 7-10 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes | 0.98 Cells per 10^3/UL | Standard Deviation 0.57 |
| Placebo | T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes | 0.77 Cells per 10^3/UL | Standard Deviation 0.58 |
Secondary
T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Neutrophils
Mean and standard deviation results of absolute neutrophils subsets is reported.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Neutrophils | 2728.6 Cells per 10^3/UL | Standard Deviation 1162.9 |
| Placebo | T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Neutrophils | 3300.0 Cells per 10^3/UL | Standard Deviation 1534.6 |
Secondary
T- and B-lymphocyte Subsets by Flow Cytometry - CD19
Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes.
Time frame: 7-10 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | T- and B-lymphocyte Subsets by Flow Cytometry - CD19 | 10.2 percentage of lymphocytes | Standard Deviation 10.8 |
| Placebo | T- and B-lymphocyte Subsets by Flow Cytometry - CD19 | 5.1 percentage of lymphocytes | Standard Deviation 8.6 |
Secondary
T- and B-lymphocyte Subsets by Flow Cytometry - CD3
Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | T- and B-lymphocyte Subsets by Flow Cytometry - CD3 | 83.6 percentage of lymphocytes | Standard Deviation 8.9 |
| Placebo | T- and B-lymphocyte Subsets by Flow Cytometry - CD3 | 89.1 percentage of lymphocytes | Standard Deviation 10.3 |
Secondary
T- and B-lymphocyte Subsets by Flow Cytometry - CD3
Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes.
Time frame: 7-10 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | T- and B-lymphocyte Subsets by Flow Cytometry - CD3 | 82.0 percentage of lymphocytes | Standard Deviation 9.9 |
| Placebo | T- and B-lymphocyte Subsets by Flow Cytometry - CD3 | 89.9 percentage of lymphocytes | Standard Deviation 11.6 |
Secondary
T- and B-lymphocyte Subsets by Flow Cytometry - CD4
Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes.
Time frame: 7-10 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | T- and B-lymphocyte Subsets by Flow Cytometry - CD4 | 48.2 percentage of lymphocytes | Standard Deviation 11.8 |
| Placebo | T- and B-lymphocyte Subsets by Flow Cytometry - CD4 | 46.5 percentage of lymphocytes | Standard Deviation 11.4 |
Secondary
T- and B-lymphocyte Subsets by Flow Cytometry - CD4
Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | T- and B-lymphocyte Subsets by Flow Cytometry - CD4 | 47.3 percentage of lymphocytes | Standard Deviation 9.8 |
| Placebo | T- and B-lymphocyte Subsets by Flow Cytometry - CD4 | 46.7 percentage of lymphocytes | Standard Deviation 7.5 |
Secondary
T- and B-lymphocyte Subsets by Flow Cytometry - CD56
Mean and standard deviation results of CD56 lymphocyte subsets is reported.
Time frame: 7-10 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | T- and B-lymphocyte Subsets by Flow Cytometry - CD56 | 6.6 percent of lymphocytes | Standard Deviation 5.6 |
| Placebo | T- and B-lymphocyte Subsets by Flow Cytometry - CD56 | 4.6 percent of lymphocytes | Standard Deviation 3.4 |
Secondary
T- and B-lymphocyte Subsets by Flow Cytometry - CD56
Mean and standard deviation results of CD56 lymphocyte subsets is reported.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | T- and B-lymphocyte Subsets by Flow Cytometry - CD56 | 7.6 percent of lymphocytes | Standard Deviation 5.5 |
| Placebo | T- and B-lymphocyte Subsets by Flow Cytometry - CD56 | 5.2 percent of lymphocytes | Standard Deviation 3.2 |
Secondary
T- and B-lymphocyte Subsets by Flow Cytometry - CD8
Mean and standard deviation results of CD8 lymphocyte subsets as a percentage of total lymphocytes.
Time frame: 7-10 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | T- and B-lymphocyte Subsets by Flow Cytometry - CD8 | 27.9 percentage of lymphocytes | Standard Deviation 8 |
| Placebo | T- and B-lymphocyte Subsets by Flow Cytometry - CD8 | 39.6 percentage of lymphocytes | Standard Deviation 10.1 |
Secondary
T- and B-lymphocyte Subsets by Flow Cytometry - CD8
Mean and standard deviation results of CD8 lymphocyte subsets as a percentage of total lymphocytes.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | T- and B-lymphocyte Subsets by Flow Cytometry - CD8 | 31.4 percentage of lymphocytes | Standard Deviation 8.1 |
| Placebo | T- and B-lymphocyte Subsets by Flow Cytometry - CD8 | 38.8 percentage of lymphocytes | Standard Deviation 7.8 |
Secondary
T- and B-lymphocyte Subsets by Flow Cytometry - Cluster of Differentiation (CD) 19
Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | T- and B-lymphocyte Subsets by Flow Cytometry - Cluster of Differentiation (CD) 19 | 8.6 percentage of lymphocytes | Standard Deviation 7.4 |
| Placebo | T- and B-lymphocyte Subsets by Flow Cytometry - Cluster of Differentiation (CD) 19 | 4.8 percentage of lymphocytes | Standard Deviation 8.3 |
Secondary
T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes
Mean and standard deviation results of lymphocytes subsets is reported.
Time frame: 7-10 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes | 23.13 Percentage of lymphocytes | Standard Deviation 8.23 |
| Placebo | T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes | 22.58 Percentage of lymphocytes | Standard Deviation 11.89 |
Secondary
T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes
Mean and standard deviation results of lymphocytes subsets is reported.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes | 27.56 Percentage of lymphocytes | Standard Deviation 9.25 |
| Placebo | T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes | 17.62 Percentage of lymphocytes | Standard Deviation 7.56 |
Secondary
T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells
Mean and standard deviation results of white blood cells subsets is reported.
Time frame: 7-10 days after study vaccination
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells | 4.05 cells per 10^3/UL | Standard Deviation 1.33 |
| Placebo | T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells | 3.24 cells per 10^3/UL | Standard Deviation 1.1 |
Secondary
T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells
Mean and standard deviation results of white blood cells subsets is reported.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FluMist | T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells | 3.91 cells per 10^3/UL | Standard Deviation 1.56 |
| Placebo | T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells | 4.19 cells per 10^3/UL | Standard Deviation 1.49 |