A Clinical Study to Assess the Safety of a New Influenza Vaccine

NCT01104493 | Completed Phase 4 Results

• 1 other identifier: CD-VA-FluMist-1045
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

To assess the safety of a new influenza virus vaccine containing a new virus strain in healthy patients prior to the release of the vaccine.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Reporting Fever, Defined as Oral Temperature ≥ 101°F

  A comparison of the rate of fever (oral temperature ≥ 101°F) reported during the 7 days post administration of investigational product between the monovalent vaccine and placebo groups.

  Study Days 1-8

Secondary Outcomes (6)

• Percentage of Participants Reporting Any Solicited Symptom

  Study Days 1-8

• Percentage of Participants Reporting Any Adverse Event.

  Study Days 1-8

• Percentage of Participants Reporting Any Solicited Symptom.

  Study Days 1-15

• Percentage of Participants Reporting Any Adverse Event.

  Study Days 1-15

• Percentage of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD), Study Days 1-29

  Study Days 1-29

Study Arms (2)

1

EXPERIMENTAL

Single dose of monovalent vaccine

Biological: Monovalent Frozen FluMist®

2

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Monovalent Frozen FluMist® BIOLOGICAL

Single dose of monovalent vaccine (240 subjects) by intranasal spray on Study Day 1.

1

Placebo OTHER

Single dose of placebo (60 subjects) by intranasal spray on Study Day 1

2

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, 18 through 49 years of age (not yet reached their 50th birthday) at the time of investigational product administration
• Healthy by medical history and physical examination
• Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the United States of America, European Union \[EU\] Data Privacy Directive in the EU) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
• Female subjects of child-bearing potential, (ie, unless at least 2 years postmenopausal, surgically sterile \[eg, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\], has sterile male partner, or practices abstinence) must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, or use of a condom with spermicide by the sexual partner) for 30 days prior to administration of investigational product, and must agree to continue using such precautions for 60 days after investigational product administration. In addition, the subject must also have a negative urine or blood pregnancy test at screening and, if screening and Day 1 do not occur on the same day, on the day of vaccination prior to randomization.
• Males, unless surgically sterile must use an effective method of birth control with a female partner and must agree to continue using such contraceptive precautions for at least 30 days after dosing with investigational product (from Study Day 1 through Study Day 31)
• Subject available by telephone
• Ability to understand and comply with the requirements of the protocol, as judged by the investigator
• Ability to complete follow-up period of 180 days after dosing as required by the protocol

You may not qualify if:

• 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
• History of hypersensitivity to gentamicin
• Acute febrile (\> 100.0°F oral or equivalent) and/or clinically significant respiratory illness (eg, cough or sore throat) within 14 days prior to randomization
• Any known immunosuppressive condition or immune deficiency disease, including human immunodeficiency virus (HIV) infection, or ongoing immunosuppressive therapy
• History of Guillain-Barré syndrome
• A household contact who is severely immunocompromised (eg, hematopoietic stem cell transplant recipient, during those periods in which the immunocompromised individual requires care in a protective environment); additionally, subject should avoid close contact with severely immunocompromised individuals for at least 21 days after receipt of investigational product
• Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 30 days after the dose of investigational product
• 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 Note: A daily dose of up to 81 mg of aspirin for prophylactic use is not considered a contraindication to enrollment.
• 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 antiviral agents within 48 hours prior to investigational product administration or expected receipt of influenza antiviral therapy or antiviral agents through 14 days after receipt of each dose of investigational product
• Known or suspected mitochondrial encephalomyopathy
• Nursing mother
• Any condition (eg, chronic cough) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
• Employees of the clinical study site, any other individuals involved with the conduct of the study, or immediate family members of such individuals

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (3)

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Columbia Research Group, Inc

Portland, Oregon, 97239, United States

Location

Results Point of Contact

• Title: Dr. Robert Gasser
• Organization: MedImmune, LLC

gasserr@medimmune.com

301-398-0000

Study Officials

• Robert A. Gasser, Jr., M.D.

  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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 15, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 18, 2011
• Results First Posted: July 14, 2011

Record last verified: 2011-07

Locations

US (3)