Clinical Trial Results:
A Phase I Randomized, Double-Blind Trial of the Safety and Immunogenicity of FluMist® A Live, Intranasal Influenza Virus Vaccine vs. Placebo in Immunocompromised Children Ages 5 Through 17 Years of Age
Summary
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EudraCT number |
2017-000849-50 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
31 Mar 2008
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Results information
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Results version number |
v1(current) |
This version publication date |
03 Jan 2018
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First version publication date |
03 Jan 2018
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
MI-CP114
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00112112 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
MedImmune, LLC
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Sponsor organisation address |
One MedImmune Way, Gaithersburg, MD, United States, 20837
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Public contact |
Raburn Mallory, MedImmune, LLC, +1 3013980000, malloryr@medimmune.com
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Scientific contact |
Raburn Mallory, MedImmune, LLC, +1 3013980000, malloryr@medimmune.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 Mar 2008
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Mar 2008
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective of this study was to describe the safety of FluMist compared with placebo in mild to moderately immunocompromised children with cancer.
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Protection of trial subjects |
The conduct of this clinical study met all local and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and are consistent with International Conference on Harmonization guideline: Good Clinical Practice, and applicable regulatory requirements. Participants signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
08 Aug 2005
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 20
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Worldwide total number of subjects |
20
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
8
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Adolescents (12-17 years) |
12
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
A total of 20 participants, 10 in the FluMist group and 10 in the placebo group, were enrolled in the study across 4 sites in the United States of America. | |||||||||
Pre-assignment
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Screening details |
A total of 20 participants were randomized in a 1:1 ratio to either the FluMist or placebo group. 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. | |||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Carer, Data analyst, Assessor | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo | |||||||||
Arm description |
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 milliliter (mL) was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Nasal spray
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Routes of administration |
Nasal use
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Dosage and administration details |
The total volume of 0.5 mL of placebo was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
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Arm title
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FluMist | |||||||||
Arm description |
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 median tissue culture infectious dose (TCID50) of each of three influenza virus strains. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
FluMist
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Nasal spray
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Routes of administration |
Nasal use
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Dosage and administration details |
The total volume of 0.5 mL of FluMist was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
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Baseline characteristics reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 milliliter (mL) was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
FluMist
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Reporting group description |
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 median tissue culture infectious dose (TCID50) of each of three influenza virus strains. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 milliliter (mL) was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). | ||
Reporting group title |
FluMist
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Reporting group description |
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 median tissue culture infectious dose (TCID50) of each of three influenza virus strains. |
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End point title |
Number of Participants who had Reactogenicity Events (REs) [1] | |||||||||
End point description |
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 were analysed for this end point. One participant in FluMist group did not have any RE data and was excluded from the RE analysis.
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End point type |
Primary
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End point timeframe |
0-42 days after study vaccination
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical analysis was not applicable since there were no inferential statistics planned for primary outcome measures, only descriptive statistics were reported. |
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No statistical analyses for this end point |
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End point title |
Number of Participants who had Serious Adverse Events (SAEs) [2] | |||||||||
End point description |
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 were analysed for this end point.
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End point type |
Primary
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End point timeframe |
0-180 days after study vaccination
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical analysis was not applicable since there were no inferential statistics planned for primary outcome measures, only descriptive statistics were reported. |
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No statistical analyses for this end point |
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End point title |
Number of Participants who had Adverse Events (AEs) [3] | |||||||||
End point description |
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 were analysed for this end point.
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End point type |
Primary
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End point timeframe |
0-42 days after study vaccination
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Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical analysis was not applicable since there were no inferential statistics planned for primary outcome measures, only descriptive statistics were reported. |
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No statistical analyses for this end point |
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End point title |
Number of Significant new Medical Conditions (SNMCs) [4] | |||||||||
End point description |
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 were analysed for this end point.
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End point type |
Primary
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End point timeframe |
43-180 days after study vaccination
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Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical analysis was not applicable since there were no inferential statistics planned for primary outcome measures, only descriptive statistics were reported. |
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No statistical analyses for this end point |
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End point title |
Number of Participants Shedding Vaccine-like Virus | |||||||||
End point description |
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 were analysed for this end point.
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End point type |
Secondary
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End point timeframe |
3-5 days after study vaccination
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No statistical analyses for this end point |
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End point title |
Number of Participants Shedding Vaccine-like Virus | |||||||||
End point description |
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 were analysed for this end point.
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End point type |
Secondary
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End point timeframe |
7-10 days after study vaccination
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No statistical analyses for this end point |
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End point title |
Number of Participants Shedding Vaccine-like Virus | |||||||||
End point description |
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 were analysed for this end point.
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End point type |
Secondary
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End point timeframe |
14-28 days after study vaccination
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No statistical analyses for this end point |
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End point title |
Number of Participants Shedding Vaccine-like Virus | |||||||||
End point description |
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 were analysed for this end point.
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End point type |
Secondary
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End point timeframe |
35-42 days after study vaccination
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No statistical analyses for this end point |
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End point title |
Number of Participants Shedding Vaccine-like Virus | |||||||||
End point description |
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 were analysed for this end point.
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End point type |
Secondary
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End point timeframe |
Unscheduled visits occurring during 0-42 days after study vaccination
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No statistical analyses for this end point |
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End point title |
T- and B-lymphocyte Subsets by Flow Cytometry - Cluster of Differentiation (CD) 19 | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
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End point type |
Secondary
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End point timeframe |
pre-dosing (Day 0)
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No statistical analyses for this end point |
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End point title |
T- and B-lymphocyte Subsets by Flow Cytometry - CD3 | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
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End point type |
Secondary
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End point timeframe |
pre-dosing (Day 0)
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No statistical analyses for this end point |
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End point title |
T- and B-lymphocyte Subsets by Flow Cytometry - CD4 | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
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End point type |
Secondary
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End point timeframe |
pre-dosing (Day 0)
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No statistical analyses for this end point |
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End point title |
T- and B-lymphocyte Subsets by Flow Cytometry - CD8 | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
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End point type |
Secondary
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End point timeframe |
pre-dosing (Day 0)
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No statistical analyses for this end point |
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End point title |
T- and B-lymphocyte Subsets by Flow Cytometry - CD19 | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
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End point type |
Secondary
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End point timeframe |
7-10 days after study vaccination
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No statistical analyses for this end point |
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End point title |
T- and B-lymphocyte Subsets by Flow Cytometry - CD3 | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
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End point type |
Secondary
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End point timeframe |
7-10 days after study vaccination
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No statistical analyses for this end point |
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End point title |
T- and B-lymphocyte Subsets by Flow Cytometry - CD4 | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
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End point type |
Secondary
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End point timeframe |
7-10 days after study vaccination
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No statistical analyses for this end point |
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End point title |
T- and B-lymphocyte Subsets by Flow Cytometry - CD8 | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
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End point type |
Secondary
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End point timeframe |
7-10 days after study vaccination
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No statistical analyses for this end point |
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End point title |
Interferon (INF)-Gamma | ||||||||||||
End point description |
Mean and standard deviation for INF-Gamma (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 sample available for the specified day were analysed for this end point.
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End point type |
Secondary
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End point timeframe |
pre-dosing (Day 0)
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No statistical analyses for this end point |
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End point title |
INF-Gamma | ||||||||||||
End point description |
Mean and standard deviation for INF-Gamma (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 sample available for the specified day were analysed for this end point.
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End point type |
Secondary
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End point timeframe |
7-10 days after study vaccination
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No statistical analyses for this end point |
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End point title |
INF-Gamma | ||||||||||||
End point description |
Mean and standard deviation for INF-Gamma (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 sample available for the specified day were analysed for this end point.
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End point type |
Secondary
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End point timeframe |
35-42 days after study vaccination
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No statistical analyses for this end point |
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End point title |
Interleukin (IL)-4 | ||||||||||||
End point description |
Mean and standard deviation for IL-4 (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 sample available for the specified day were analysed for this end point.
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End point type |
Secondary
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End point timeframe |
pre-dosing (Day 0)
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No statistical analyses for this end point |
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End point title |
IL-4 | ||||||||||||
End point description |
Mean and standard deviation for IL-4 (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 sample available for the specified day were analysed for this end point.
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End point type |
Secondary
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End point timeframe |
7-10 days after study vaccination
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No statistical analyses for this end point |
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End point title |
IL-4 | ||||||||||||
End point description |
Mean and standard deviation for IL-4 (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 sample available for the specified day were analysed for this end point.
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End point type |
Secondary
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End point timeframe |
35-42 days after study vaccination
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No statistical analyses for this end point |
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End point title |
Human Leukocyte Antigen (HLA) Matched Tetramers CD8+ | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
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End point type |
Secondary
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End point timeframe |
pre-dosing (Day 0)
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No statistical analyses for this end point |
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End point title |
HLA Matched Tetramers CD8+ | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
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End point type |
Secondary
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End point timeframe |
7-10 days after study vaccination
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No statistical analyses for this end point |
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End point title |
HLA Matched Tetramers CD8+ | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
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End point type |
Secondary
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End point timeframe |
35-42 days after study vaccination
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No statistical analyses for this end point |
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End point title |
Number of Participants who Experienced a >= 4-fold Rise in Serum Influenza A/H1N1 Hemagglutination Inhibition (HAI) Titers From Baseline to Day 35-42 | |||||||||
End point description |
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 samples available for the specified days were analysed for this end point.
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End point type |
Secondary
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End point timeframe |
Baseline (Pre-dosing on Day 0) and Day 35-42 after study vaccination
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No statistical analyses for this end point |
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End point title |
Number of Participants who Experienced a >= 4-fold Rise in Serum Influenza A/H3N2 HAI Titers From Baseline to Day 35-42 | |||||||||
End point description |
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 samples available for the specified days were analysed for this end point.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Baseline (Pre-dosing on Day 0) and Day 35-42 after study vaccination
|
|||||||||
|
||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of Participants who Experienced a >= 4-fold Rise in Serum Influenza B HAI Titers From Baseline to Day 35-42 | |||||||||
End point description |
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 samples available for the specified days were analysed for this end point.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Baseline (Pre-dosing on Day 0) and Day 35-42 after study vaccination
|
|||||||||
|
||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of Participants who Experienced a >= 4-fold Rise in Serum Influenza A/H1N1 Microneutralization Titers From Baseline to Day 35-42 | |||||||||
End point description |
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 samples available for the specified days were analysed for this end point.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Baseline (Pre-dosing on Day 0) and Day 35-42 after study vaccination
|
|||||||||
|
||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of Participants who Experienced a >= 4-fold Rise in Serum Influenza A/H3N2 Microneutralization Titers From Baseline to Day 35-42 | |||||||||
End point description |
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 samples available for the specified days were analysed for this end point.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Baseline (Pre-dosing on Day 0) and Day 35-42 after study vaccination
|
|||||||||
|
||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of Participants who Experienced a >= 4-fold Rise in Serum Influenza B Microneutralization Titers From Baseline to Day 35-42 | |||||||||
End point description |
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 samples available for the specified days were analysed for this end point.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Baseline (Pre-dosing on Day 0) and Day 35-42 after study vaccination
|
|||||||||
|
||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza A/H1N1 Immunoglobulin A (IgA) | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
pre-dosing (Day 0)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza A/H1N1 IgA | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
3-5 days after study vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza A/H1N1 IgA | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
7-10 days after study vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza A/H1N1 IgA | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
14-28 days after study vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza A/H1N1 IgA | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
35-42 days after study vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza A/H3N2 IgA | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
pre-dosing (Day 0)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza A/H3N2 IgA | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
3-5 days after study vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza A/H3N2 IgA | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
7-10 days after study vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza A/H3N2 IgA | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
14-28 days after study vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza A/H3N2 IgA | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
35-42 days after study vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza B IgA | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
pre-dosing (Day 0)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza B IgA | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
3-5 days after study vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza B IgA | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
7-10 days after study vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza B IgA | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
14-28 days after study vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza B IgA | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
35-42 days after study vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
T- and B-lymphocyte Subsets by Flow Cytometry - CD56 | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
pre-dosing (Day 0)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
T- and B-lymphocyte Subsets by Flow Cytometry - CD56 | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
7-10 days after study vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
pre-dosing (Day 0)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
7-10 days after study vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
pre-dosing (Day 0)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
7-10 days after study vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
pre-dosing (Day 0)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
7-10 days after study vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Neutrophils | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
pre-dosing (Day 0)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza A/H1N1 Immunoglobulin G (IgG) | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
pre-dosing (Day 0)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza A/H1N1 IgG | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
35-42 days after study vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza A/H3N2 IgG | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
pre-dosing (Day 0)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza A/H3N2 IgG | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
35-42 days after study vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza B IgG | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
pre-dosing (Day 0)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza B IgG | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
35-42 days after study vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza A/H1N1 Immunoglobulin M (IgM) | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
pre-dosing (Day 0)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza A/H1N1 IgM | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
35-42 days after study vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza A/H3N2 IgM | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
pre-dosing (Day 0)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza A/H3N2 IgM | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
35-42 days after study vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza B IgM | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
pre-dosing (Day 0)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Influenza B IgM | ||||||||||||
End point description |
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 sample available for the specified day were analysed for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
35-42 days after study vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
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Timeframe for reporting adverse events |
Adverse events (AEs) were collected from the time of investigational product administration through Day 42. Serious adverse events (SAEs) were collected from the time of study drug administration through Day 180.
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Adverse event reporting additional description |
Participants who received any study vaccine and had any follow-up for REs and/or AEs were analysed for AEs and SAEs.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
11.0
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Reporting groups
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Reporting group title |
Placebo
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Reporting group description |
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). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
FluMist
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Reporting group description |
The total volume of 0.5 mL of FluMist was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID50 (median tissue culture infectious dose) of each of three influenza virus strains. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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17 Mar 2005 |
• The number of study sites was increased. The isolation procedures specific to St. Jude’s were modified to reflect those recommended by the Advisory Committee on Immunization Practices, to accommodate procedures across multiple study sites. The reporting period of significant new medical conditions was clarified.
• The exclusion criteria were clarified and/or modified to accommodate participants/regimens across multiple study sites. Specifically, the exclusion criterion for cluster of differentiation 4 (CD4) + T-cell count < 500 cells/mm^3 was revised to CD4 + T-cell percentage < 15%; the exclusion criterion for B-cell count < 5% was deleted; and the absolute neutrophil count ANC count <= 500 cells/mm3 at screening was revised at study entry.
• The screening period was extended to within 16 days before study dosing. Central randomization was implemented with the change to a multiple site study, and the randomization procedures were described. The conditions under which additional participants could be enrolled were added.
• The identity and concentration of the influenza virus strains for FluMist study vaccine were revised based on the strains used in the commercially available vaccine during the 2004-2005 influenza season.
• The allocation of participants to each treatment group was revised to “approximately” 10 due to the change to a multiple center study.
• Collection of radiation therapy with concomitant medication use was added.
• The schedule of participant evaluations was revised to accommodate chemotherapy regimens for potential study participants. The reporting period for safety events and the collection procedures for blood samples and nasal specimens were revised or clarified.
• Study visits at Days 3 through 5 and Days 17 through 28 were revised to be clinic or at-home visits.
• Significant new medical conditions were added as a safety event that would be assessed for severity and for relationship to study vaccine. |
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08 Mar 2006 |
• Safety information from an immunosuppressed animal model were added.
• Safety information for the first four participants vaccinated in the 2005 enrollment period was added.
• The Day 17 to 28 visit was revised to occur from Day 14 to 21, with an additional contact on Day 22 to 28, for safety monitoring purposes. Biomarkers for immune response were revised based on actual testing parameters.
• Criterion #6 was modified to clarify current status for participants with hematologic malignancy.
• Criterion #15 was revised to clarify pregnancy testing. Criterion #19 was modified to have the ANC evaluation be within 24 hours of study entry to possibly avoid multiple blood draws on the same day. Criteria #20 and #21 were combined and modified to exclude only participants who were receiving highdose steroids for >= 14 days, which is consistent with the AAP Red Book guidelines for administration of live viral vaccines.
• The staggered enrollment schedule was revised to reflect enrollment of the first 4 participants in the 2005 summer enrollment period
• The vaccine strains that were to be administered to participants entered during the 2006 enrollment period were updated. The relevant years and influenza seasons were revised to reflect enrollment in a second season. FluMist storage conditions were updated to be consistent with the current labelling. |
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16 Jan 2007 |
• Information was updated to reflect clinical research use of the refrigerated formulation that had been recently approved. Data from a pivotal pediatric efficacy trial were added.
• Safety and shedding data were added for a second pediatric trial in human immunodeficiency virus-infected children. Safety, shedding, and immunogenicity data were added for a post-marketing trial in children and adults.
• Updated safety information was provided for the 12 participants who had been enrolled in the first two years of the study. Text was added to reflect target enrollment in 2007 at the end of the 2006-2007 influenza season.
• Influenza vaccine strain information was updated for 2007 enrollment.
• Pregnancy was added as an immediately reportable event due to the age of the participants eligible for this study. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |