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This prospective annual release study is designed to evaluate the safety of 2 new influenza virus vaccine strains to be included in FluMist Quadrivalent for the 2018-2019 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 subjects will be randomly assigned in a 4:1 fashion to receive a single dose of bivalent 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 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 |
|---|---|---|---|
| Bivalent influenza vaccine | Experimental | A single dose of bivalent vaccine (10^7±5 fluorescent focus unit of 2 cold-adapted, attenuated, temperature-sensitive, 6:2 reassortant influenza strain) will be administered as intranasal spray on Day 1 |
|
| Placebo | Placebo Comparator | A single dose of placebo matched to bivalent influenza vaccine will be administered as intranasal spray on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bivalent influenza vaccine | Biological | A single dose of bivalent vaccine (10^7±5 fluorescent focus unit of 2 cold-adapted, attenuated, temperature-sensitive, 6:2 reassortant influenza strain) will be administered as intranasal spray on Day 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Fever (Oral Temperature >= 101 Degrees Fahrenheit) Through Day 8 | Percentage of participants with fever (oral temperature >= 101 degrees Fahrenheit) through Day 8 is reported. | Day 1 through Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Solicited Symptoms Through Day 8 | For this study, solicited symptoms included oral fever (> 100 degrees Fahrenheit), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity (tiredness), and headache. | Day 1 through Day 8 |
| Number of Participants With Solicited Symptoms Through Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathan Segall, MD | Clinical Research Atlanta | Principal Investigator |
| Keith Klatt, MD | Columbia Research Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Stockbridge | Georgia | 30281 | United States | ||
| Research Site |
Not provided
| Label | URL |
|---|---|
| Protocol and Statistical Analysis Plan (SAP) | View source |
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The study was conducted between 06Jun2018 and 27Dec2018 in the USA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received a single dose of placebo matched to bivalent vaccine by intranasal spray. |
| FG001 | Bivalent Vaccine | Participants received a single dose of bivalent vaccine by intranasal spray. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent-to-treat (ITT) population included all randomized and treated participants, grouped according to actual treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received a single dose of placebo matched to bivalent vaccine by intranasal spray. |
| BG001 | Bivalent Vaccine | Participants received a single dose of bivalent vaccine by intranasal spray. |
| 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 Reporting Fever (Oral Temperature >= 101 Degrees Fahrenheit) Through Day 8 | Percentage of participants with fever (oral temperature >= 101 degrees Fahrenheit) through Day 8 is reported. | The ITT population included all randomized and treated participants, grouped according to actual treatment. | Posted | Number | Percentage of participants | Day 1 through Day 8 |
|
For SAEs: Day 1 through Day 181 For non-serious AEs: Day 1 through Day 15
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.
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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 matched to bivalent vaccine by intranasal spray. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear discomfort | Ear and labyrinth disorders | MedDRA 21.0 | 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 27, 2018 | Nov 21, 2019 | 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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| Placebo | Other | A single dose of placebo matched to bivalent influenza vaccine will be administered as intranasal spray on Day 1. |
|
For this study, solicited symptoms included oral fever (> 100 degrees Fahrenheit), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity (tiredness), and headache. |
| Day 1 through Day 15 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Through Day 8 and Day 15 | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. | Day 1 through Day 8; Day 1 through Day 15 |
| Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Through Day 29 and Day 181 | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A 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. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. | Day 1 through Day 29; Day 1 through Day 181 |
| Number of Participants With New Onset Chronic Diseases (NOCDs) Through Day 29 and Day 181 | An NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant. | Day 1 through Day 29; Day 1 through Day 181 |
| Portland |
| Oregon |
| 97239 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Secondary | Number of Participants With Solicited Symptoms Through Day 8 | For this study, solicited symptoms included oral fever (> 100 degrees Fahrenheit), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity (tiredness), and headache. | The ITT population included all randomized and treated participants, grouped according to actual treatment. | Posted | Count of Participants | Participants | Day 1 through Day 8 |
|
|
|
| Secondary | Number of Participants With Solicited Symptoms Through Day 15 | For this study, solicited symptoms included oral fever (> 100 degrees Fahrenheit), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity (tiredness), and headache. | The ITT population included all randomized and treated participants, grouped according to actual treatment. | Posted | Count of Participants | Participants | Day 1 through Day 15 |
|
|
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Through Day 8 and Day 15 | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. | The ITT population included all randomized and treated participants, grouped according to actual treatment. | Posted | Count of Participants | Participants | Day 1 through Day 8; Day 1 through Day 15 |
|
|
|
| Secondary | Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Through Day 29 and Day 181 | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A 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. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. | The ITT population included all randomized and treated participants, grouped according to actual treatment. | Posted | Count of Participants | Participants | Day 1 through Day 29; Day 1 through Day 181 |
|
|
|
| Secondary | Number of Participants With New Onset Chronic Diseases (NOCDs) Through Day 29 and Day 181 | An NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant. | The ITT population included all randomized and treated participants, grouped according to actual treatment. | Posted | Count of Participants | Participants | Day 1 through Day 29; Day 1 through Day 181 |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 2 |
| 60 |
| EG001 | Bivalent Vaccine | Participants received a single dose of bivalent vaccine by intranasal spray. | 0 | 240 | 1 | 240 | 19 | 240 |
| Vertigo | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Stress fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Nasal pruritus | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 21.0 | 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 |
| >103 degrees Fahrenheit |
|
| Runny nose |
|
| Sore throat |
|
| Cough |
|
| Vomiting |
|
| Muscle aches |
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| Chills |
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| Decreased activity (tiredness) |
|
| Headache |
|
| >102 degrees Fahrenheit |
|
| >103 degrees Fahrenheit |
|
| Runny nose |
|
| Sore throat |
|
| Cough |
|
| Vomiting |
|
| Muscle aches |
|
| Chills |
|
| Decreased activity (tiredness) |
|
| Headache |
|