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

NCT01579916 | Completed Phase 4 Results

• 1 other identifier: CD-VA-FluMist-1114
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 3

Brief Summary

This prospective annual release study was designed to assess the safety of a trivalent influenza virus vaccine using two new strains recommended for the 2012-2013 influenza season not previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy adults will receive a single dose of vaccine or placebo and will be followed for 180 days after study vaccination.

Conditions

Influenza

Keywords

Trivalent, Influenza, FluMist, Vaccine, Prevention

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Reporting Fever Within 7 Days Post Vaccination

  A comparison of the rate of fever, defined as oral temperature greater than or equal to 101 degrees Fahrenheit, reported during the 7 days post administration of investigational product between the trivalent influenza virus vaccine and placebo groups.

  Study Days 1 - 8

Secondary Outcomes (10)

• Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination

  Study Days 1- 8

• Percentage of Participants Reporting Any Adverse Event (AE) Within 7 Days Post Vaccination

  Study Days 1 - 8

• Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination

  Study Days 1 - 15

• Percentage of Participants Reporting Any Adverse Event (AE) Within 14 Days Post Vaccination

  Study Days 1 - 15

• Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 28 Days Post Vaccination

  Study Days 1 - 29

Study Arms (2)

Trivalent Influenza Virus Vaccine

EXPERIMENTAL

Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.

Biological: Trivalent Influenza Virus Vaccine

Placebo

PLACEBO COMPARATOR

Placebo is suppllied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.

Other: Placebo

Interventions

Trivalent Influenza Virus Vaccine BIOLOGICAL

Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.

Trivalent Influenza Virus Vaccine

Placebo OTHER

Placebo is suppllied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered 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 at the time of investigational product administration
• Written informed consent and any locally required authorization (ie, HIPAA in the USA) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
• Females of childbearing potential who are sexually active with a nonsterilized male partner must use effective contraception for 30 days prior to study vaccination, and must agree to continue using such precautions for 60 days after study vaccination
• Nonsterilized males who are sexually active with a female partner of child-bearing potential must use an effective method of contraception from prior to study vaccination amd must agree to continue using such precautions for at least 30 days after receipt study vaccination
• Healthy by medical history and physical examination
• Female subjects of child-bearing potential 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.
• 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:

• Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
• Concurrent enrollment in another clinical study up to 180 days after receipt of investigational product (Day 181)
• Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
• 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
• Any condition for which the inactivated influenza vaccine is indicated, including chronic disorders of the pulmonary or cardiovascular systems (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 (\> 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 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 study vaccination
• Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 30 days after study vaccination (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 study vaccination
• Expected receipt of antipyretic or analgesic medication on a daily or every other day basis from randomization through 14 days after study vaccination
• Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after study vaccination
• Receipt of influenza antiviral therapy or antiviral agents within 48 hours prior to study vaccination or expected receipt of influenza antiviral therapy or antiviral agents through 14 days after study vaccination

Sponsors & Collaborators

• MedImmune LLC: lead
• AstraZeneca: collaborator

Study Sites (3)

Research Site

Miami, Florida, 33143, United States

Location

Research Site

Stockbridge, Georgia, 30281, United States

Location

Research Site

Portland, Oregon, 97239, United States

Location

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, 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: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2012
• First Posted: April 18, 2012
• Study Start: May 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 3, 2014
• Results First Posted: February 3, 2014

Record last verified: 2013-12

Locations

US (3)