D2560C00015 FluMist Annual Safety Study 2018

NCT03564444 | Completed Phase 4 Results FDA Drug

• 1 other identifier: D2560C00015
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Influenza; Healthy

Keywords

Bivalent.; Influenza.; FluMist Quadrivalent.; Vaccine Prevention in Healthy Adults.

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Reporting Fever (Oral Temperature >= 101 Degrees Fahrenheit) Through Day 8

  Percentage of participants with fever (oral temperature \>= 101 degrees Fahrenheit) through Day 8 is reported.

  Day 1 through Day 8

Secondary Outcomes (5)

• Number of Participants With Solicited Symptoms Through Day 8

  Day 1 through Day 8

• Number of Participants With Solicited Symptoms Through Day 15

  Day 1 through Day 15

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) Through Day 8 and Day 15

  Day 1 through Day 8; Day 1 through Day 15

• Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Through Day 29 and Day 181

  Day 1 through Day 29; Day 1 through Day 181

• Number of Participants With New Onset Chronic Diseases (NOCDs) Through Day 29 and Day 181

  Day 1 through Day 29; Day 1 through Day 181

Study Arms (2)

Bivalent influenza vaccine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Bivalent influenza vaccine BIOLOGICAL

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.

Bivalent influenza vaccine

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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), 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.

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (2)

Research Site

Stockbridge, Georgia, 30281, United States

Location

Research Site

Portland, Oregon, 97239, United States

Location

Related Links

• Protocol and Statistical Analysis Plan (SAP)

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Raburn Mallory
• Organization: MedImmune, LLC

information.center@astrazeneca.com

+1-301-398-5799

Study Officials

• Nathan Segall, MD

  Clinical Research Atlanta

  PRINCIPAL INVESTIGATOR

• Keith Klatt, MD

  Columbia Research Group

  PRINCIPAL INVESTIGATOR

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: June 11, 2018
• First Posted: June 20, 2018
• Study Start: June 6, 2018
• Primary Completion: December 27, 2018
• Study Completion: December 27, 2018
• Last Updated: December 26, 2019
• Results First Posted: December 26, 2019

Record last verified: 2019-12

Locations

US (2)