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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 2017-2018 influenza season.
This prospective, randomized, double-blind, placebo-controlled release study will enroll approximately 300 healthy adults 18 to 49 years of age (not yet reached their 50th birthday). Eligible participants 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 2 sites in the United States of America. Each participant will receive 1 dose of investigational product on Day 1. The duration of study participation for each participant 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 | Participants will receive 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 strain] by intranasal spray on Day 1. |
|
| Placebo | Placebo Comparator | Participants will receive a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monovalent Influenza Vaccine | Biological | A single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 FFU of each of 1 ca, att, ts 6:2 reassortant influenza strain] 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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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Stockbridge | Georgia | 30281 | United States | ||
| Research Site |
A total of 300 participants were randomized and participated in the study.
The study was conducted from 30 May 2017 to 14 Dec 2017 at 2 sites in the United States of America (USA).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 strain] by intranasal spray on Day 1. |
| FG001 | Placebo | Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The intent-to-treat (ITT) population included all participants who were randomized and treated with investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 strain] by intranasal spray on Day 1. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The ITT population included all participants who were randomized and treated with investigational product. |
| 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 who were randomized and treated with investigational product. | Posted | Number | Percentage of Participants | Baseline (Day 1) up to Day 8 |
|
Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) 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 | 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 strain] by intranasal spray on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endometriosis | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear congestion | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raburn Mallory | MedImmune, LLC | +1-301-398-5799 | information.center@astrazeneca.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2017 | Dec 10, 2018 | Prot_SAP_000.pdf |
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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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Double-blind
| Placebo | Other | A single dose of placebo matching with 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 serious adverse event (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 |
| Portland |
| Oregon |
| 97239 |
| United States |
| Placebo |
Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | The ITT population included all participants who were randomized and treated with investigational product. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | The ITT population included all participants who were randomized and treated with investigational product. | Count of Participants | Participants |
|
| Race (NIH/OMB) | The ITT population included all participants who were randomized and treated with investigational product. | Count of Participants | Participants |
|
Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1. |
|
|
|
| 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 who 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 who were randomized and treated with investigational product. | Posted | Count of Participants | 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 serious adverse event (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 who were randomized and treated with investigational product. | Posted | Count of Participants | 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 who were randomized and treated with investigational product. | Posted | Number | Percentage of participants | Baseline (Day 1) up to Day 8 and Day 15 |
|
|
|
| 0 |
| 240 |
| 1 |
| 240 |
| 19 |
| 240 |
| EG001 | Placebo | Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1. | 0 | 60 | 0 | 60 | 1 | 60 |
| Ear pain | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.0 | 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 |
| 0.4 |
| 2-Sided |
| 95 |
| -14.1 |
| 13.2 |
| Superiority |
| TESAEs: Up to Day 181 |
|
| NOCDs: Up to Day 181 |
|