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D2560C00015 FluMist Annual Safety Study 2018

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03564444
Recruitment Status : Completed
First Posted : June 20, 2018
Results First Posted : December 26, 2019
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Influenza Healthy Biological: Bivalent influenza vaccine Other: Placebo Phase 4

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 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 4, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety of 2 New of 6:2 Influenza Virus Reassortants in Adults
Actual Study Start Date : June 6, 2018
Actual Primary Completion Date : December 27, 2018
Actual Study Completion Date : December 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bivalent influenza vaccine
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
 Biological: Bivalent influenza vaccine
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 Comparator: Placebo
A single dose of placebo matched to bivalent influenza vaccine will be administered as intranasal spray on Day 1.
 Other: Placebo
A single dose of placebo matched to bivalent influenza vaccine will be administered as intranasal spray on Day 1.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Reporting Fever (Oral Temperature >= 101 Degrees Fahrenheit) Through Day 8 [ Time Frame: Day 1 through Day 8 ]
    Percentage of participants with fever (oral temperature >= 101 degrees Fahrenheit) through Day 8 is reported.


Secondary Outcome Measures :
  1. Number of Participants With Solicited Symptoms Through Day 8 [ Time Frame: Day 1 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.

  2. Number of Participants With Solicited Symptoms Through Day 15 [ Time Frame: Day 1 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.

  3. Number of Participants With Treatment-emergent Adverse Events (TEAEs) Through Day 8 and Day 15 [ Time Frame: Day 1 through Day 8; Day 1 through 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.

  4. Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Through Day 29 and Day 181 [ Time Frame: Day 1 through Day 29; Day 1 through 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.

  5. Number of Participants With New Onset Chronic Diseases (NOCDs) Through Day 29 and Day 181 [ Time Frame: Day 1 through Day 29; Day 1 through 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.


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 through 49 years
  • Written informed consent
  • Subject available by telephone
  • Ability to understand and comply with the requirements of the protocol, as judged by the Investigator

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), renaldysfunction, 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564444


Locations
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United States, Georgia
Research Site
Stockbridge, Georgia, United States, 30281
United States, Oregon
Research Site
Portland, Oregon, United States, 97239
Sponsors and Collaborators
MedImmune LLC
Investigators
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Principal Investigator: Nathan Segall, MD Clinical Research Atlanta
Principal Investigator: Keith Klatt, MD Columbia Research Group
  Study Documents (Full-Text)

Documents provided by MedImmune LLC:
Study Protocol and Statistical Analysis Plan  [PDF] March 27, 2018

More Information
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Additional Information:

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Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT03564444    
Other Study ID Numbers: D2560C00015
First Posted: June 20, 2018    Key Record Dates
Results First Posted: December 26, 2019
Last Update Posted: December 26, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MedImmune LLC:
Bivalent.
Influenza.
FluMist Quadrivalent.
Vaccine Prevention in Healthy Adults.
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases