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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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This prospective annual release study is designed to evaluate the safety of 3 new influenza virus vaccine strains to be included in FluMist Quadrivalent for the 2015-2016 influenza season
This prospective, randomized, double-blind, placebo-controlled release study will enroll approximately 300 healthy adults 18 to 49 years of age. Eligible participants will be randomly assigned in a 4:1 fashion to receive a single dose of trivalent 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 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 181 days after study vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trivalent Influenza Vaccine | Experimental | A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) per strain of trivalent influenza vaccine will be administered as intranasal spray on Day 1. |
|
| Placebo | Placebo Comparator | A single dose of placebo matched to trivalent influenza vaccine will be administered as intranasal spray on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trivalent Influenza Vaccine | Biological | A single dose of 10^(7.0 ± 0.5) FFU per strain of trivalent 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) within 8 days after vaccination and all solicited symptoms within 15 days after vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashwin Swami, MD | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | South Miami | Florida | United States | |||
| Research Site |
A total of 300 participants were randomized and participated in the study from 15-Jun-2015 through 15-Jan-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 trivalent influenza vaccine by intranasal spray on Day 1. |
| FG001 | Trivalent Influenza Vaccine | Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 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 trivalent influenza vaccine by intranasal spray on Day 1. |
| BG001 | Trivalent Influenza Vaccine | Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 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 Participant | 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 trivalent influenza vaccine by intranasal spray on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lacrimation increased | Eye disorders | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashwin Swami, MD | MedImmune, LLC | +1 301 398 5000 | 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 trivalent 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 within 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 Disease (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 within 29 days and 181 days after vaccination. | Baseline (Day 1) up to Day 29 and 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 |
| United States |
| Research Site | Portland | Oregon | 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) within 8 days after vaccination and all solicited symptoms within 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 within 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 Disease (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 within 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 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 |
| 60 |
| 3 |
| 60 |
| EG001 | Trivalent Influenza Vaccine | Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1. | 1 | 240 | 14 | 240 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Rate Difference |
| 17.9 |
| 2-Sided |
| 95 |
| 4.4 |
| 29.3 |
| No |
| Superiority or Other |
| Up to Day 181: TESAEs |
|
| Up to Day 181: NOCDs |
|