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Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults for the 2015-2016 Season (FluMist)

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ClinicalTrials.gov Identifier: NCT02473510
Recruitment Status : Completed
First Posted : June 16, 2015
Results First Posted : November 28, 2016
Last Update Posted : November 28, 2016
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
MedImmune LLC

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Influenza Healthy Biological: Trivalent 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. 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 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 3 New 6:2 Influenza Virus Reassortants in Adults
Study Start Date : June 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Trivalent Influenza Vaccine
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.
Biological: Trivalent Influenza Vaccine
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.

Placebo Comparator: Placebo
A single dose of placebo matched to trivalent influenza vaccine will be administered as intranasal spray on Day 1.
Other: Placebo
A single dose of placebo matched to trivalent 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) within 8 days after vaccination and all solicited symptoms within 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 within 8 days and 15 days after vaccination.

  3. Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Disease (NOCDs) [ Time Frame: Baseline (Day 1) up to Day 29 and 181 ]
    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.

  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

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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
  • Participant 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), 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 prior to randomization
  • Any known immunosuppressive condition or immune deficiency disease, including human immunodeficiency virus infection, or ongoing immunosuppressive therapy
  • History of Guillain-Barré syndrome

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): NCT02473510


Locations
United States, Florida
Research Site
South Miami, Florida, United States
United States, Georgia
Research Site
Stockbridge, Georgia, United States
United States, Oregon
Research Site
Portland, Oregon, United States
Sponsors and Collaborators
MedImmune LLC
AstraZeneca
Investigators
Study Director: Ashwin Swami, MD MedImmune LLC

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02473510     History of Changes
Other Study ID Numbers: D2560C00009
First Posted: June 16, 2015    Key Record Dates
Results First Posted: November 28, 2016
Last Update Posted: November 28, 2016
Last Verified: October 2016

Keywords provided by MedImmune LLC:
Trivalent
Influenza
FluMist Quadrivalent
Vaccine
Prevention
Healthy

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs