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

NCT02473510 | Completed Phase 4 Results

• 1 other identifier: D2560C00009
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 3

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

Conditions

Influenza; Healthy

Keywords

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

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 Disease (NOCDs)

  Baseline (Day 1) up to Day 29 and 181

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

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

Study Arms (2)

Trivalent Influenza Vaccine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Trivalent Influenza Vaccine BIOLOGICAL

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.

Trivalent Influenza Vaccine

Placebo OTHER

A single dose of placebo matched to trivalent 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 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

Sponsors & Collaborators

• MedImmune LLC: lead
• AstraZeneca: collaborator

Study Sites (3)

Research Site

South Miami, Florida, United States

Location

Research Site

Stockbridge, Georgia, United States

Location

Research Site

Portland, Oregon, 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: Ashwin Swami, MD
• Organization: MedImmune, LLC

information.center@astrazeneca.com

+1 301 398 5000

Study Officials

• Ashwin Swami, MD

  MedImmune LLC

  STUDY DIRECTOR

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 12, 2015
• First Posted: June 16, 2015
• Study Start: June 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: November 28, 2016
• Results First Posted: November 28, 2016

Record last verified: 2016-10

Locations

US (3)