A Prospective Study to Evaluate the Safety of a New Trivalent Intranasal Influenza Vaccine

NCT00677820 | Completed Phase 4 Results

• 1 other identifier: MI-MA182
• Study Type: interventional
• Target: 300
• 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 a new strain recommended for the 2008-2009 influenza season not previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy adults received a single dose of vaccine or placebo and were followed for 180 days.

Conditions

Influenza

Keywords

Influenza; FluMist; vaccine; prevention; trivalent

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Reporting Fever

  Fever was defined as oral temperature greater than or equal to 101 degrees Fahrenheit.

  Days 0-7

Secondary Outcomes (6)

• Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7

  Days 0-7

• Number of Subjects Reporting Any Adverse Event (AE) Post-treatment

  Days 0-7

• Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14

  Days 0-14

• Number of Subjects Reporting Any AEs Post Treatment

  Days 0-14

• Number of Subjects Reporting Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC)

  Days 0-28

Study Arms (2)

Trivalent influenza virus vaccine

EXPERIMENTAL

Frozen trivalent vaccine containing new strains

Biological: Trivalent influenza virus vaccine

Placebo

PLACEBO COMPARATOR

treatment with placebo

Biological: Placebo

Interventions

Trivalent influenza virus vaccine BIOLOGICAL

Trivalent vaccine was 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 three cold-adapted, attenuated, 6:2 reassortant influenza strains A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006.

Trivalent influenza virus vaccine

Placebo BIOLOGICAL

Placebo was supplied in intranasal sprayers containing 0.5 ml of sucrose-phosphate buffer.

Placebo

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 to 49 years of age (not yet reached their 50th birthday) at the time of study vaccination
• Healthy by medical history and health assessment
• Sexually active females, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral, implanted, injectable, or transdermal contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for at least 30 days prior to study vaccination, and must agree to continue using such precautions for at least 90 days after study vaccination; the subject must also have a negative serum or urine pregnancy test within 14 days prior to study vaccination (if screening and study vaccination do not occur on the same day) and on the day of study vaccination prior to randomization
• Sexually active males, unless surgically sterile, must use an effective method of birth control (condom or abstinence) and must agree to continue using such precautions for at least 30 days after study vaccination
• Available by telephone
• Provide written informed consent (and HIPAA authorization, if applicable)
• 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 study vaccination as required by the protocol

You may not qualify if:

• History of hypersensitivity to any component of the vaccine, including egg or egg protein
• 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 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); subject should additionally 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 180 days after study vaccination (use of licensed agents for indications not listed in the package insert is permitted)
• Expected receipt of anti-pyretic or analgesic medication on a daily or every other day basis from randomization through 14 days after study vaccination 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 study vaccination
• Nursing mother
• Employee of the research center, any individual involved with the conduct of the study, or any family member of such individuals
• Any condition (eg, chronic cough, allergic rhinitis) that, in the opinion of the investigator, would interfere with evaluation of the vaccine or interpretation of study results

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (3)

Covance, Daytona Beach

Daytona Beach, Florida, 32117, United States

Location

Covance, Portland

Portland, Oregon, 97239, United States

Location

Covance, Austin

Austin, Texas, 78752, 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/ Sr Dir Clinical Development
• Organization: MedImmune LLC, an affiliate of AstraZeneca

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

Study Record Dates

• First Submitted: May 13, 2008
• First Posted: May 15, 2008
• Study Start: June 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 22, 2010
• Results First Posted: September 15, 2010

Record last verified: 2010-10

Locations

US (3)