Influenza Immunity Against Pandemic Respiratory Virus

NCT00138281 | Completed Phase 4

• 1 other identifier: 03-183
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Sixty adults, ages 18-49, will be randomly assigned to receive either FluMist or Fluzone. Some of the subjects will have participated in previous studies for these 2 vaccines. The study will last 4 months with subject participation being 28 days. The purpose of this study is to measure immune response to the vaccinations.

Conditions

Influenza

Keywords

influenza, vaccine, respiratory virus, Fluzone, FluMist

Interventions

FluMist BIOLOGICAL

Fluzone BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

• Healthy adult, aged 18-49 years who have or have not participated in the Year 1 protocol.
• Willing to sign informed consent.
• Availability for follow-up for the planned duration of the study at least 4 weeks after immunization.
• Acceptable medical history by screening evaluation and brief clinical assessment.
• Negative urine or serum pregnancy test for women of childbearing potential.
• If the subject is female and of childbearing potential, she must use an acceptable contraception and not become pregnant for the duration of the study. (Acceptable contraception includes implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner).

You may not qualify if:

• History of immunodeficiency.
• Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
• History of Guillain-Barré syndrome.
• Malignancy, other than squamous cell or basal cell skin cancer.
• Autoimmune disease.
• History of asthma or reactive airways disease.
• Chronic cardiovascular and pulmonary disorder.
• Chronic metabolic diseases (including diabetes), renal dysfunction or hemoglobinopathies requiring regular medical follow-up or hospitalization during the preceding year.
• Use of immunosuppressive medication. Corticosteroid nasal sprays are permissible.
• Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol.
• Inactivated vaccine 14 days prior to vaccination.
• Live, attenuated vaccines within 60 days of study.
• Use of investigational agents within 30 days prior to study.
• Receipt of blood products or immunoglobulin in the past 6 months.
• Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

FluMist; 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 30, 2005
• Primary Completion: November 1, 2005
• Study Completion: January 1, 2006
• Last Updated: August 27, 2010

Record last verified: 2010-03

Locations

US (1)