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Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2017-2018 Season (FluMist)

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: NCT03158038
Recruitment Status : Completed
First Posted : May 17, 2017
Results First Posted : January 4, 2019
Last Update Posted : January 4, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
MedImmune LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Influenza Healthy Biological: Monovalent 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 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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Prevention
Official Title: A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults
Actual Study Start Date : May 30, 2017
Actual Primary Completion Date : December 14, 2017
Actual Study Completion Date : December 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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.
Biological: Monovalent Influenza Vaccine
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.
Other: Placebo
A single dose of placebo matching with monovalent influenza vaccine will be administered as intranasal spray on Day 1.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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

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

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): NCT03158038


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
AstraZeneca
  Study Documents (Full-Text)

Documents provided by MedImmune LLC:
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Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT03158038    
Other Study ID Numbers: D2560C00014
First Posted: May 17, 2017    Key Record Dates
Results First Posted: January 4, 2019
Last Update Posted: January 4, 2019
Last Verified: December 2018

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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:
Trivalent
Influenza
FluMist Quadrivalent
Vaccine
Prevention
Healthy
Monovalent
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases