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


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Verified May 2017 by MedImmune LLC

Sponsor:

Collaborator:

AstraZeneca

Information provided by (Responsible Party):

MedImmune LLC

ClinicalTrials.gov Identifier:

NCT03158038

First received: May 16, 2017

Last updated: May 16, 2017

Last verified: May 2017

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.

Influenza
Healthy
Biological: Monovalent Influenza Vaccine
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Primary Outcome Measures:

Secondary Outcome Measures:

  • Percentage of Participants With Solicited Symptoms [ Time Frame: Within 7 and 14 days after vaccination ]

    Solicited symptoms are predefined symptoms or events to be specifically inquired about and assessed daily after vaccine administration up to 14 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 will be reported for all solicited symptoms except fever >= 101 degrees F (reported as primary outcome) within 7 days after vaccination and all solicited symptoms within 14 days after vaccination.

  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Within 7 and 14 days after vaccination ]

    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 are events between administration of study drug and up to 14 days after vaccination that are absent before treatment or that worsened relative to pre-treatment state. Results will be given for AEs reported within 7 days and 14 days after vaccination.

  • Number of Partipants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs) [ Time Frame: Within 28 and 180 days after vaccination ]

    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 are serious events between administration of study drug and up to 180 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 will be given for TESAEs and NOCDs reported within 28 days and 180 days after vaccination.

  • Percentage of Participants Who Require Antipyretic and/or Analgesic Medication [ Time Frame: Within 7 and 14 days after vaccination ]

Estimated Enrollment: 300
Anticipated Study Start Date: May 28, 2017
Estimated Study Completion Date: December 22, 2017
Estimated Primary Completion Date: December 22, 2017 (Final data collection date for primary outcome measure)
Experimental: Monovalent Influenza Vaccine

A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) strain of monovalent influenza vaccine will be administered as intranasal spray on Day 1.

Biological: Monovalent Influenza Vaccine

A single dose of 10^(7.0 +/- 0.5) FFU strain of monovalent influenza vaccine will be administered as intranasal spray on Day 1.

Placebo Comparator: Placebo

A single dose of placebo matched to monovalent influenza vaccine will be administered as intranasal spray on Day 1.

Other: Placebo

A single dose of placebo matched to monovalent influenza vaccine will be administered as intranasal spray on Day 1.

This prospective, randomized, double-blind, placebo-controlled release study will enroll approximately 300 healthly 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 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 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.

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

Key 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

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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03158038

Research Site
Stockbridge, Georgia, United States, 30281
Research Site
Portland, Oregon, United States, 97239

MedImmune LLC

AstraZeneca

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT03158038     History of Changes
Other Study ID Numbers: D2560C00014
Study First Received: May 16, 2017
Last Updated: May 16, 2017

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:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 17, 2017