NCT02743117

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 2016-2017 influenza season

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
301

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

May 2, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
10 months until next milestone

Results Posted

Study results publicly available

October 4, 2017

Completed
Last Updated

October 4, 2017

Status Verified

October 1, 2017

Enrollment Period

7 months

First QC Date

April 14, 2016

Results QC Date

August 22, 2017

Last Update Submit

October 2, 2017

Conditions

InfluenzaHealthy

Keywords

TrivalentInfluenzaFluMist QuadrivalentVaccinePreventionHealthyMonovalent

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)

    Percentage of participants with fever defined as oral temperature \>=101 degrees F were reported.

    Baseline (Day 1) up to Day 8

Secondary Outcomes (4)

  • Percentage of Participants With Solicited Symptoms

    Baseline (Day 1) up to Day 8 and Day 15

  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    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)

    Baseline (Day 1) up to Day 29 and Day 181

  • Percentage of Participants Who Require Antipyretic and/or Analgesic Medication

    Baseline (Day 1) up to Day 8 and Day 15

Study Arms (2)

Monovalent Influenza Vaccine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Monovalent Influenza VaccineBIOLOGICAL

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

Monovalent Influenza Vaccine
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

South Miami, Florida, 33143, United States

Location

Research Site

Stockbridge, Georgia, 30281, United States

Location

Research Site

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Raburn Mallory, MD
Organization
MedImmune, LLC
information.center@astrazeneca.com
301-398-000

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2016

First Posted

April 19, 2016

Study Start

May 2, 2016

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

October 4, 2017

Results First Posted

October 4, 2017

Record last verified: 2017-10

Locations

US(3)