Comparison of Delivery Routes of Flu Vaccine in Adults

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00170547
First received: September 9, 2005
Last updated: August 11, 2011
Last verified: July 2006
  Purpose

This protocol is to compare the immune response of different influenza vaccines given by two different routes of administration in healthy adults ages 18 to 64 years.


Condition Intervention Phase
Influenza
Biological: Influenza Virus Vaccine Trivalent Types A and B
Biological: Fluzone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of a Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route Compared to an Intramuscular Vaccination With Fluzone(R) in Healthy Adults

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment: 1597
Study Start Date: September 2005
Estimated Study Completion Date: February 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Detailed Description:

This is a multi-center, randomized, partially blinded trial to compare the safety and immunogenicity of intramuscularly versus intradermally administered influenza vaccine in healthy 18-64 year old adults. Subjects will have blood drawn immediately prior to and approximately three to four weeks after vaccination. After the completion of the trial, all subjects will be offered influenza vaccine of the 2005-2006 formulation.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject is healthy, as determined by medical history
  2. Over 18 years of age and not yet 65 years old
  3. Provides written informed consent
  4. Able to attend all scheduled visits and to comply with all trial procedures
  5. Women may be menopausal of 1 year or more or sugically sterile. Women of child-bearing potential must agree to be abstinent or to use a licensed form of barrier or hormonal contraception for the entire study period, and have a negative pregnancy test within 24 hours prior to vaccination.

Exclusion Criteria:

  1. Breast-feeding
  2. Receipt of an investigational drug, biologic or device in the 4 weeks preceding the trial vaccination
  3. Planned participation in another clinical trial during the present trial period
  4. History of Guillain-Barré Syndrome
  5. Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy
  6. Hypersensitivity to any of the vaccine components (including eggs or egg products or thimerosol and gelatin) or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
  7. Chronic illness that could interfere with trial conduct or completion
  8. Blood or blood-derived products received in the past 3 months
  9. Has received any inactivated vaccine within 2 weeks or live vaccine within 4 weeks prior to enrollment into this study
  10. Vaccination planned within the 4 weeks following the trial vaccination
  11. Known current HIV, hepatitis B (HBsAg) or hepatitis C infection or seropositivity
  12. Prior vaccination against influenza within the past 6 months
  13. Allergy shot in the 7-day period prior to enrollment and must not be scheduled to receive any allergy shots in the 7-day period after enrollment
  14. On coumadin or heparin therapy or has known thrombocytopenia or bleeding disorder contraindicating vaccination
  15. Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
  16. Febrile illness temperature >= 37.5°C on Day 0, prior to enrollment and vaccination
  17. Any condition, that, in the opinion of the investigator, would pose a health risk to the participant
  18. History of alcohol or drug abuse in the last 5 years
  19. Planned travel outside the US between vaccination and the second study visit
  20. Presence of any active skin disease at the injection site that, in the opinion of the Investigator, would impact vaccine delivery or assessment of vaccination site
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170547

Locations
United States, California
Stanford University
Stanford, California, United States, 94305
UCLA Center For Vaccine Research
Torrance, California, United States, 90509
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Maryland
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201
United States, Missouri
Saint Louis University
St. Louis, Missouri, United States, 63110-0250
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27704
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Robert Johnson, HHS/NIAID/DMID
ClinicalTrials.gov Identifier: NCT00170547     History of Changes
Other Study ID Numbers: 05-0075
Study First Received: September 9, 2005
Last Updated: August 11, 2011
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
inactivated, trivalent, influenza, vaccine, Fluzone

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014