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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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This prospective annual release study is designed to evaluate the safety of 1 new influenza virus vaccine strain to be included in FluMist Quadrivalent for the 2016-2017 influenza season
This prospective, randomized, double-blind, placebo-controlled release study will enroll approximately 300 healthy adults 18 to 49 years of age. Eligible subjects will be randomly assigned in a 4:1 fashion to receive a single dose of monovalent vaccine or placebo by intranasal spray. Randomization will be stratified by site. This study will be conducted at 3 sites in the United States of America. Each subject will receive 1 dose of investigational product on Day 1. The duration of study participation for each subject is the time from study vaccination through 180 days after study vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monovalent Influenza Vaccine | Experimental | A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) strain of monovalent influenza vaccine will be administered as intranasal spray on Day 1. |
|
| Placebo | Placebo Comparator | A single dose of placebo matched to monovalent influenza vaccine will be administered as intranasal spray on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monovalent Influenza Vaccine | Biological | A single dose of 10^(7.0 ± 0.5) FFU strain of monovalent influenza vaccine will be administered as intranasal spray on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F) | Percentage of participants with fever defined as oral temperature >=101 degrees F were reported. | Baseline (Day 1) up to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Solicited Symptoms | Solicited symptoms are predefined symptoms or events specifically inquired about and assessed daily after vaccine administration up to 15 days after vaccination. The solicited symptoms include fever greater than (>) 100.0 degrees F (37.8 degrees Celsius), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity and headache. Results were reported for all solicited symptoms except fever >=101 degrees F (reported as primary outcome) up to 8 days after vaccination and all solicited symptoms up to 15 days after vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | South Miami | Florida | 33143 | United States | ||
| Research Site |
One participant was considered as screen failure and 300 randomized participants were treated in the study.
A total of 301 participants were randomized and participated in the study from 02-May-2016 through 30-Nov-2016 at 3 sites in the United States of America (USA).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1. |
| FG001 | Monovalent Influenza Vaccine | Participants received a single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The intent-to-treat (ITT) population included all participants that were randomized and treated with investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1. |
| BG001 | Monovalent Influenza Vaccine | Participants received a single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1. |
| 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 | Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F) | Percentage of participants with fever defined as oral temperature >=101 degrees F were reported. | The intent-to-treat (ITT) population included all participants that were randomized and treated with investigational product. | Posted | Number | Percentage of participants | Baseline (Day 1) up to Day 8 |
|
Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181
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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 | Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raburn Mallory, MD | MedImmune, LLC | 301-398-000 | information.center@astrazeneca.com |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Placebo | Other | A single dose of placebo matched to monovalent influenza vaccine will be administered as intranasal spray on Day 1. |
|
| Baseline (Day 1) up to Day 8 and Day 15 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were events between administration of study drug and up to 15 days after vaccination that are absent before treatment or that worsened relative to pre-treatment state. Results were given for AEs reported up to 8 days and 15 days after vaccination. | Baseline (Day 1) up to Day 8 and Day 15 |
| Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs) | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent SAEs were serious events between administration of study drug and up to 181 days after the dose that are absent before treatment or that worsen relative to pretreatment state. An NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant. Results were given for TESAEs and NOCDs reported up to 29 days and 181 days after vaccination. | Baseline (Day 1) up to Day 29 and Day 181 |
| Percentage of Participants Who Require Antipyretic and/or Analgesic Medication | Percentage of participants who require antipyretic and/or analgesic medication were reported. | Baseline (Day 1) up to Day 8 and Day 15 |
| Stockbridge |
| Georgia |
| 30281 |
| United States |
| Research Site | Portland | Oregon | 97239 | United States |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | Percentage of Participants With Solicited Symptoms | Solicited symptoms are predefined symptoms or events specifically inquired about and assessed daily after vaccine administration up to 15 days after vaccination. The solicited symptoms include fever greater than (>) 100.0 degrees F (37.8 degrees Celsius), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity and headache. Results were reported for all solicited symptoms except fever >=101 degrees F (reported as primary outcome) up to 8 days after vaccination and all solicited symptoms up to 15 days after vaccination. | The ITT population included all participants that were randomized and treated with investigational product. | Posted | Number | Percentage of participants | Baseline (Day 1) up to Day 8 and Day 15 |
|
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were events between administration of study drug and up to 15 days after vaccination that are absent before treatment or that worsened relative to pre-treatment state. Results were given for AEs reported up to 8 days and 15 days after vaccination. | The ITT population included all participants that were randomized and treated with investigational product. | Posted | Number | Participants | Baseline (Day 1) up to Day 8 and Day 15 |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs) | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent SAEs were serious events between administration of study drug and up to 181 days after the dose that are absent before treatment or that worsen relative to pretreatment state. An NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant. Results were given for TESAEs and NOCDs reported up to 29 days and 181 days after vaccination. | The ITT population included all participants that were randomized and treated with investigational product. | Posted | Number | Participants | Baseline (Day 1) up to Day 29 and Day 181 |
|
|
|
| Secondary | Percentage of Participants Who Require Antipyretic and/or Analgesic Medication | Percentage of participants who require antipyretic and/or analgesic medication were reported. | The ITT population included all participants that were randomized and treated with investigational product. | Posted | Number | Percentage of participants | Baseline (Day 1) up to Day 8 and Day 15 |
|
|
|
| 0 |
| 59 |
| 1 |
| 59 |
| EG001 | Monovalent Influenza Vaccine | Participants received a single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1. | 0 | 241 | 14 | 241 |
| Food poisoning | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on-going 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.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Rate Difference |
| -7.4 |
| 2-Sided |
| 95 |
| -21.6 |
| 5.9 |
| Superiority or Other |
| Up to Day 181: TESAEs |
|
| Up to Day 181: NOCDs |
|