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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FluMist | Active Comparator | 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. |
|
| Placebo | Placebo Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FluMist | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0-42 days after study vaccination |
| 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. | 0-180 days after study vaccination |
| 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. | 0-42 days after study vaccination |
| 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. | 43-180 days after study vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Shedding Vaccine-like Virus | Number of participants with nasal swab samples that contained vaccine-like virus are reported. | 3-5 days after study vaccination |
| Number of Participants Shedding Vaccine-like Virus |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raburn Mallory, MD | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester School of Medicine & Dentistry | Rochester | New York | 14642 | United States | ||
| Stony Brook University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21496468 | Result | Halasa N, Englund JA, Nachman S, Weinberg GA, Huber VC, Allison K, Dubovsky F, Yi T, McCullers JA, Flynn PM. Safety of live attenuated influenza vaccine in mild to moderately immunocompromised children with cancer. Vaccine. 2011 May 31;29(24):4110-5. doi: 10.1016/j.vaccine.2011.03.097. Epub 2011 Apr 13. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | participants | 0-42 days after study vaccination |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raburn Mallory | MedImmune, LLC | 301-398-0000 | malloryr@medimmune.com |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000613429 | FluMist |
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|
| Placebo | Biological | 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 with nasal swab samples that contained vaccine-like virus are reported.
| 7-10 days after study vaccination |
| Number of Participants Shedding Vaccine-like Virus | Number of participants with nasal swab samples that contained vaccine-like virus are reported. | 14-28 days after study vaccination |
| 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. | 35-42 days after study vaccination |
| Number of Participants Shedding Vaccine-like Virus | Number of participants with nasal swab samples that contained vaccine-like virus are reported. | Unscheduled visits occurring during 0-42 days after study vaccination |
| 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. | pre-dosing (Day 0) |
| T- and B-lymphocyte Subsets by Flow Cytometry - CD3 | Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes. | pre-dosing (Day 0) |
| T- and B-lymphocyte Subsets by Flow Cytometry - CD4 | Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes. | pre-dosing (Day 0) |
| T- and B-lymphocyte Subsets by Flow Cytometry - CD8 | Mean and standard deviation results of CD8 lymphocyte subsets as a percentage of total lymphocytes. | pre-dosing (Day 0) |
| T- and B-lymphocyte Subsets by Flow Cytometry - CD19 | Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes. | 7-10 days after study vaccination |
| T- and B-lymphocyte Subsets by Flow Cytometry - CD3 | Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes. | 7-10 days after study vaccination |
| T- and B-lymphocyte Subsets by Flow Cytometry - CD4 | Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes. | 7-10 days after study vaccination |
| T- and B-lymphocyte Subsets by Flow Cytometry - CD8 | Mean and standard deviation results of CD8 lymphocyte subsets as a percentage of total lymphocytes. | 7-10 days after study vaccination |
| Interferon (INF)-Gamma | Mean and standard deviation spots-forming cells per 10^5 T cells is reported. | pre-dosing (Day 0) |
| INF-Gamma | Mean and standard deviation spots-forming cells per 10^5 T cells is reported. | 7-10 days after study vaccination |
| INF-Gamma | Mean and standard deviation spots-forming cells per 10^5 T cells is reported. | 35-42 days after study vaccination |
| Interleukin (IL)-4 | Mean and standard deviation spots-forming cells per 10^5 T cells is reported. | pre-dosing (Day 0) |
| IL-4 | Mean and standard deviation spots-forming cells per 10^5 T cells is reported. | 7-10 days after study vaccination |
| IL-4 | Mean and standard deviation spots-forming cells per 10^5 T cells is reported. | 35-42 days after study vaccination |
| 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. | pre-dosing (Day 0) |
| 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. | 7-10 days after study vaccination |
| 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. | 35-42 days after study vaccination |
| 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. | Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination |
| 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. | Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination |
| 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. | Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination |
| 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. | Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination |
| 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. | Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination |
| 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. | Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination |
| 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. | pre-dosing (Day 0) |
| Influenza A/H1N1 IgA | Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 3-5 days after study vaccination |
| Influenza A/H1N1 IgA | Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 7-10 days after study vaccination |
| Influenza A/H1N1 IgA | Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 14-28 days after study vaccination |
| Influenza A/H1N1 IgA | Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 35-42 days after study vaccination |
| Influenza A/H3N2 IgA | Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | pre-dosing (Day 0) |
| Influenza A/H3N2 IgA | Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 3-5 days after study vaccination |
| Influenza A/H3N2 IgA | Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 7-10 days after study vaccination |
| Influenza A/H3N2 IgA | Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 14-28 days after study vaccination |
| Influenza A/H3N2 IgA | Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 35-42 days after study vaccination |
| Influenza B IgA | Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | pre-dosing (Day 0) |
| Influenza B IgA | Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 3-5 days after study vaccination |
| Influenza B IgA | Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 7-10 days after study vaccination |
| Influenza B IgA | Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 14-28 days after study vaccination |
| Influenza B IgA | Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 35-42 days after study vaccination |
| T- and B-lymphocyte Subsets by Flow Cytometry - CD56 | Mean and standard deviation results of CD56 lymphocyte subsets is reported. | pre-dosing (Day 0) |
| T- and B-lymphocyte Subsets by Flow Cytometry - CD56 | Mean and standard deviation results of CD56 lymphocyte subsets is reported. | 7-10 days after study vaccination |
| T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells | Mean and standard deviation results of white blood cells subsets is reported. | pre-dosing (Day 0) |
| T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells | Mean and standard deviation results of white blood cells subsets is reported. | 7-10 days after study vaccination |
| T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes | Mean and standard deviation results of lymphocytes subsets is reported. | pre-dosing (Day 0) |
| T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes | Mean and standard deviation results of lymphocytes subsets is reported. | 7-10 days after study vaccination |
| T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes | Mean and standard deviation results of absolute lymphocytes subsets is reported. | pre-dosing (Day 0) |
| T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes | Mean and standard deviation results of absolute lymphocytes subsets is reported. | 7-10 days after study vaccination |
| T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Neutrophils | Mean and standard deviation results of absolute neutrophils subsets is reported. | pre-dosing (Day 0) |
| 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. | pre-dosing (Day 0) |
| Influenza A/H1N1 IgG | Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 35-42 days after study vaccination |
| Influenza A/H3N2 IgG | Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | pre-dosing (Day 0) |
| Influenza A/H3N2 IgG | Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 35-42 days after study vaccination |
| Influenza B IgG | Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | pre-dosing (Day 0) |
| Influenza B IgG | Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 35-42 days after study vaccination |
| 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. | pre-dosing (Day 0) |
| Influenza A/H1N1 IgM | Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 35-42 days after study vaccination |
| Influenza A/H3N2 IgM | Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | pre-dosing (Day 0) |
| Influenza A/H3N2 IgM | Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 35-42 days after study vaccination |
| Influenza B IgM | Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | pre-dosing (Day 0) |
| Influenza B IgM | Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 35-42 days after study vaccination |
| Stony Brook |
| New York |
| 11794 |
| United States |
| St. Jude's Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| Children's Hospital Regional Medical Center | Seattle | Washington | 98105 | United States |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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). |
|
|
| 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. | Participants who received any study vaccine and had any follow-up for REs and/or AEs. | Posted | Number | Participants | 0-180 days after study vaccination |
|
|
|
| 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. | Participants who received any study vaccine and had any follow-up for REs and/or AEs. | Posted | Number | participants | 0-42 days after study vaccination |
|
|
|
| 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. | Participants who received any study vaccine and had any follow-up for REs and/or AEs. | Posted | Number | events | 43-180 days after study vaccination |
|
|
|
| Secondary | Number of Participants Shedding Vaccine-like Virus | Number of participants with nasal swab samples that contained vaccine-like virus are reported. | Participants who received any study vaccine and had any follow-up for REs and/or AEs. | Posted | Number | participants | 3-5 days after study vaccination |
|
|
|
| Secondary | Number of Participants Shedding Vaccine-like Virus | Number of participants with nasal swab samples that contained vaccine-like virus are reported. | Participants who received any study vaccine and had any follow-up for REs and/or AEs. | Posted | Number | participants | 7-10 days after study vaccination |
|
|
|
| Secondary | Number of Participants Shedding Vaccine-like Virus | Number of participants with nasal swab samples that contained vaccine-like virus are reported. | Participants who received any study vaccine and had any follow-up for REs and/or AEs. | Posted | Number | participants | 14-28 days after study vaccination |
|
|
|
| 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. | Participants who received any study vaccine and had any follow-up for REs and/or AEs. | Posted | Number | participants | 35-42 days after study vaccination |
|
|
|
| Secondary | Number of Participants Shedding Vaccine-like Virus | Number of participants with nasal swab samples that contained vaccine-like virus are reported. | Participants who received any study vaccine and had any follow-up for REs and/or AEs. | Posted | Number | participants | Unscheduled visits occurring during 0-42 days after study vaccination | participants w/unsched. illness visits | participants w/unsched. illness visits |
|
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|
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of lymphocytes | pre-dosing (Day 0) |
|
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|
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of lymphocytes | pre-dosing (Day 0) |
|
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|
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of lymphocytes | pre-dosing (Day 0) |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of lymphocytes | pre-dosing (Day 0) |
|
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| 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. | 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. | Posted | Mean | Standard Deviation | percentage of lymphocytes | 7-10 days after study vaccination |
|
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| 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. | 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. | Posted | Mean | Standard Deviation | percentage of lymphocytes | 7-10 days after study vaccination |
|
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| 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. | 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. | Posted | Mean | Standard Deviation | percentage of lymphocytes | 7-10 days after study vaccination |
|
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| 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. | 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. | Posted | Mean | Standard Deviation | percentage of lymphocytes | 7-10 days after study vaccination |
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| Secondary | Interferon (INF)-Gamma | Mean and standard deviation spots-forming cells per 10^5 T cells is reported. | 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. | Posted | Mean | Standard Deviation | cells per 10^5 T cells | pre-dosing (Day 0) |
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| Secondary | INF-Gamma | Mean and standard deviation spots-forming cells per 10^5 T cells is reported. | 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. | Posted | Mean | Standard Deviation | cells per 10^5 T cells | 7-10 days after study vaccination |
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| Secondary | INF-Gamma | Mean and standard deviation spots-forming cells per 10^5 T cells is reported. | 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. | Posted | Mean | Standard Deviation | cells per 10^5 T cells | 35-42 days after study vaccination |
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| Secondary | Interleukin (IL)-4 | Mean and standard deviation spots-forming cells per 10^5 T cells is reported. | 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. | Posted | Mean | Standard Deviation | cells per 10^5 T cells | pre-dosing (Day 0) |
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| Secondary | IL-4 | Mean and standard deviation spots-forming cells per 10^5 T cells is reported. | 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. | Posted | Mean | Standard Deviation | cells per 10^5 T cells | 7-10 days after study vaccination |
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| Secondary | IL-4 | Mean and standard deviation spots-forming cells per 10^5 T cells is reported. | 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. | Posted | Mean | Standard Deviation | cells per 10^5 T cells | 35-42 days after study vaccination |
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| 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. | 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. | Posted | Mean | Standard Deviation | Percentage of lymphocytes | pre-dosing (Day 0) |
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| 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. | 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. | Posted | Mean | Standard Deviation | Percentage of lymphocytes | 7-10 days after study vaccination |
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| 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. | 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. | Posted | Mean | Standard Deviation | Percentage of lymphocytes | 35-42 days after study vaccination |
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| 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. | 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. | Posted | Number | participants | Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination |
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| 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. | 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. | Posted | Number | participants | Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination |
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| 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. | 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. | Posted | Number | participants | Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination |
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| 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. | 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. | Posted | Number | participants | Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination |
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| 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. | 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. | Posted | Number | participants | Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination |
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| 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. | 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. | Posted | Number | participants | Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination |
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| 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. | 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. | Posted | Mean | Standard Deviation | titer | pre-dosing (Day 0) |
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| 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. | 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. | Posted | Mean | Standard Deviation | titer | 3-5 days after study vaccination |
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| 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. | 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. | Posted | Mean | Standard Deviation | titer | 7-10 days after study vaccination |
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| 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. | 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. | Posted | Mean | Standard Deviation | titer | 14-28 days after study vaccination |
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| 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. | 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. | Posted | Mean | Standard Deviation | titer | 35-42 days after study vaccination |
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| 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. | 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. | Posted | Mean | Standard Deviation | titer | pre-dosing (Day 0) |
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| 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. | 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. | Posted | Mean | Standard Deviation | titer | 3-5 days after study vaccination |
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|
| 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. | 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. | Posted | Mean | Standard Deviation | titer | 7-10 days after study vaccination |
|
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|
| 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. | 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. | Posted | Mean | Standard Deviation | titer | 14-28 days after study vaccination |
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|
| 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. | 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. | Posted | Mean | Standard Deviation | titer | 35-42 days after study vaccination |
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|
| Secondary | Influenza B IgA | Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 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. | Posted | Mean | Standard Deviation | titer | pre-dosing (Day 0) |
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|
| Secondary | Influenza B IgA | Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 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. | Posted | Mean | Standard Deviation | titer | 3-5 days after study vaccination |
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|
| Secondary | Influenza B IgA | Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 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. | Posted | Mean | Standard Deviation | titer | 7-10 days after study vaccination |
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|
| Secondary | Influenza B IgA | Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 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. | Posted | Mean | Standard Deviation | titer | 14-28 days after study vaccination |
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|
| Secondary | Influenza B IgA | Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 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. | Posted | Mean | Standard Deviation | titer | 35-42 days after study vaccination |
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| Secondary | T- and B-lymphocyte Subsets by Flow Cytometry - CD56 | Mean and standard deviation results of CD56 lymphocyte subsets is reported. | 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. | Posted | Mean | Standard Deviation | percent of lymphocytes | pre-dosing (Day 0) |
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| Secondary | T- and B-lymphocyte Subsets by Flow Cytometry - CD56 | Mean and standard deviation results of CD56 lymphocyte subsets is reported. | 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. | Posted | Mean | Standard Deviation | percent of lymphocytes | 7-10 days after study vaccination |
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| Secondary | T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells | Mean and standard deviation results of white blood cells subsets is reported. | 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. | Posted | Mean | Standard Deviation | cells per 10^3/UL | pre-dosing (Day 0) |
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| Secondary | T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells | Mean and standard deviation results of white blood cells subsets is reported. | 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. | Posted | Mean | Standard Deviation | cells per 10^3/UL | 7-10 days after study vaccination |
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|
| Secondary | T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes | Mean and standard deviation results of lymphocytes subsets is reported. | 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. | Posted | Mean | Standard Deviation | Percentage of lymphocytes | pre-dosing (Day 0) |
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|
| Secondary | T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes | Mean and standard deviation results of lymphocytes subsets is reported. | 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. | Posted | Mean | Standard Deviation | Percentage of lymphocytes | 7-10 days after study vaccination |
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|
|
| Secondary | T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes | Mean and standard deviation results of absolute lymphocytes subsets is reported. | 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. | Posted | Mean | Standard Deviation | Cells per 10^3/UL | pre-dosing (Day 0) |
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|
|
| Secondary | T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes | Mean and standard deviation results of absolute lymphocytes subsets is reported. | 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. | Posted | Mean | Standard Deviation | Cells per 10^3/UL | 7-10 days after study vaccination |
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|
| Secondary | T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Neutrophils | Mean and standard deviation results of absolute neutrophils subsets is reported. | 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. | Posted | Mean | Standard Deviation | Cells per 10^3/UL | pre-dosing (Day 0) |
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|
| 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. | 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. | Posted | Mean | Standard Deviation | titer | pre-dosing (Day 0) |
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|
|
| 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. | 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. | Posted | Mean | Standard Deviation | titer | 35-42 days after study vaccination |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | titer | pre-dosing (Day 0) |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | titer | 35-42 days after study vaccination |
|
|
|
| Secondary | Influenza B IgG | Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 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. | Posted | Mean | Standard Deviation | titer | pre-dosing (Day 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. | 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. | Posted | Mean | Standard Deviation | titer | 35-42 days after study vaccination |
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|
|
| 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. | 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. | Posted | Mean | Standard Deviation | titer | pre-dosing (Day 0) |
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|
|
| 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. | 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. | Posted | Mean | Standard Deviation | titer | 35-42 days after study vaccination |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | titer | pre-dosing (Day 0) |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | titer | 35-42 days after study vaccination |
|
|
|
| Secondary | Influenza B IgM | Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 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. | Posted | Mean | Standard Deviation | titer | pre-dosing (Day 0) |
|
|
|
| Secondary | Influenza B IgM | Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. | 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. | Posted | Mean | Standard Deviation | titer | 35-42 days after study vaccination |
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| 3 |
| 10 |
| 9 |
| 10 |
| EG001 | 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. | 1 | 10 | 5 | 10 |
| Bacteraemia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 11.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Animal scratch | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Oral intake reduced | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Skin chapped | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
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.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |