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
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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:
MedlinePlus related topics:
Flu
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
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) |
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:
- Subject is healthy, as determined by medical history
- Over 18 years of age and not yet 65 years old
- Provides written informed consent
- Able to attend all scheduled visits and to comply with all trial procedures
- 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:
- Breast-feeding
- Receipt of an investigational drug, biologic or device in the 4 weeks preceding the trial vaccination
- Planned participation in another clinical trial during the present trial period
- History of Guillain-Barré Syndrome
- 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
- 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
- Chronic illness that could interfere with trial conduct or completion
- Blood or blood-derived products received in the past 3 months
- Has received any inactivated vaccine within 2 weeks or live vaccine within 4 weeks prior to enrollment into this study
- Vaccination planned within the 4 weeks following the trial vaccination
- Known current HIV, hepatitis B (HBsAg) or hepatitis C infection or seropositivity
- Prior vaccination against influenza within the past 6 months
- 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
- On coumadin or heparin therapy or has known thrombocytopenia or bleeding disorder contraindicating vaccination
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- Febrile illness temperature >= 37.5°C on Day 0, prior to enrollment and vaccination
- Any condition, that, in the opinion of the investigator, would pose a health risk to the participant
- History of alcohol or drug abuse in the last 5 years
- Planned travel outside the US between vaccination and the second study visit
- 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
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 May 21, 2013