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

NCT03158038 | Completed Phase 4 Results FDA Drug

• 1 other identifier: D2560C00014
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Influenza; Healthy

Keywords

Trivalent; Influenza; FluMist Quadrivalent; Vaccine; Prevention; Healthy; Monovalent

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

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

Placebo

PLACEBO COMPARATOR

Participants will receive a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.

Other: Placebo

Interventions

Monovalent Influenza Vaccine BIOLOGICAL

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.

Monovalent Influenza Vaccine

Placebo OTHER

A single dose of placebo matching with monovalent 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
• Participant 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 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

Sponsors & Collaborators

• MedImmune LLC: lead
• AstraZeneca: collaborator

Study Sites (2)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Raburn Mallory
• Organization: MedImmune, LLC

information.center@astrazeneca.com

+1-301-398-5799

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
• Masking Details: Double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 17, 2017
• Study Start: May 30, 2017
• Primary Completion: December 14, 2017
• Study Completion: December 14, 2017
• Last Updated: January 4, 2019
• Results First Posted: January 4, 2019

Record last verified: 2018-12

Locations

US (2)