Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults

NCT01859143 | Completed Phase 4 Results

• 1 other identifier: MED-VA-FLUMIST-1156
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

This prospective annual release study is designed to evaluate the safety on new influenza virus vaccine strains to be included in FluMist Quadrivalent for the 2013-2014 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.

  Within 7 days after vaccination

Secondary Outcomes (4)

• Percentage of Participants With Solicited Symptoms

  Within 7 and 14 days after vaccination

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

  Within 7 and 14 days after vaccination

• Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs)

  Within 28 and 180 days after vaccination

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

  Within 7 and 14 days after vaccination

Study Arms (2)

Trivalent Influenza Vaccine

EXPERIMENTAL

A single dose of 10\^(7.0 +/- 0.5) fluorescent focus units (FFU) 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 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
• 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

Sponsors & Collaborators

• MedImmune LLC: lead
• AstraZeneca: collaborator

Study Sites (3)

Research Site

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: Raburn Mallory, MD/Senior Director, Clinical Development
• Organization: MedImmune, LLC

malloryr@medimmune.com

301-398-0000

Study Officials

• Raburn Mallory, 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: May 17, 2013
• First Posted: May 21, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 10, 2014
• Results First Posted: November 10, 2014

Record last verified: 2014-11

Locations

US (3)