- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03158038
Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2017-2018 Season (FluMist)
December 10, 2018 updated by: MedImmune LLC
A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Stockbridge, Georgia, United States, 30281
- Research Site
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- Age 18 through 49 years
- Written informed consent
- Participant available by telephone
- Ability to understand and comply with the requirements of the protocol, as judged by the Investigator
Key Exclusion Criteria:
- Concurrent enrollment in another clinical study up to 180 days after receipt of investigational product (Day 181)
- History of hypersensitivity to any component of the vaccine, including egg or egg protein or serious, life threatening, or severe reactions to previous influenza vaccinations
- Any condition for which the inactivated influenza vaccine is indicated, including chronic disorders of the pulmonary or cardiovascular systems (example [eg], asthma), chronic metabolic diseases (eg, diabetes mellitus), renal dysfunction, or hemoglobinopathies that required regular medical follow-up or hospitalization during the preceding year
- Acute febrile (greater than [>] 100.0 degrees Fahrenheit [F] oral or equivalent) and/or clinically significant respiratory illness (example, cough or sore throat) within 14 days to randomization
- Any known immunosuppressive condition or immune deficiency diseases, including human immunodeficiency virus infection, or ongoing immunosuppressive therapy
- History of Guillain-Barre syndrome
- Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 30 days after the dose of investigational product (use of licensed agents for indications not listed in the Package Insert is permitted)
- Receipt of any non-study vaccine within 30 days prior to randomization, or expected receipt through 30 days after receipt of investigational product
- Expected receipt of antipyretic or analgesic medication on a daily or every other day basis from randomization through 14 days after receipt of investigational product
- Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after administration of investigational product
- Receipt of influenza antiviral therapy or influenza antiviral agents within 48 hours prior to investigational product administration or expected receipt of influenza antiviral therapy or influenza antiviral agents through 14 days after receipt of investigational product
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Monovalent Influenza Vaccine
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.
|
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.
|
Placebo Comparator: Placebo
Participants will receive a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
|
A single dose of placebo matching with monovalent influenza vaccine will be administered as intranasal spray on Day 1.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)
Time Frame: Baseline (Day 1) up to Day 8
|
Percentage of participants with fever defined as oral temperature >=101 degrees F were reported.
|
Baseline (Day 1) up to Day 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Solicited Symptoms
Time Frame: Baseline (Day 1) up to Day 8 and Day 15
|
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.
|
Baseline (Day 1) up to Day 8 and Day 15
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Baseline (Day 1) up to 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.
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
|
Percentage of Participants Who Require Antipyretic and/or Analgesic Medication
Time Frame: Baseline (Day 1) up to Day 8 and Day 15
|
Percentage of participants who require antipyretic and/or analgesic medication were reported.
|
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)
Time Frame: Baseline (Day 1) up to Day 29 and Day 181
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 30, 2017
Primary Completion (Actual)
December 14, 2017
Study Completion (Actual)
December 14, 2017
Study Registration Dates
First Submitted
May 16, 2017
First Submitted That Met QC Criteria
May 16, 2017
First Posted (Actual)
May 17, 2017
Study Record Updates
Last Update Posted (Actual)
January 4, 2019
Last Update Submitted That Met QC Criteria
December 10, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D2560C00014
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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