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Comparison of Delivery Routes of Flu Vaccine in Adults

Primary Purpose

Influenza

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Trivalent inactivated influenza vaccine
Trivalent inactivated influenza vaccine
Trivalent inactivated influenza vaccine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring inactivated, trivalent, influenza, vaccine, Fluzone

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stanford University School of Medicine
  • UCLA Center For Vaccine Research
  • University of Iowa - Vaccine Research & Education Unit
  • University of Maryland Baltimore
  • Saint Louis University
  • University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases
  • Duke Health Center
  • Cincinnati Children's Hospital Medical Center
  • Vanderbilt University
  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 3

Group 4

Group 1

Group 2

Arm Description

382 subjects will receive one 3 mcg dose of Fluzone intradermally using the Mantoux technique on Day 0,

382 subjects will receive one 15 mcg dose Fluzone vaccine intramuscularly (IM) on Day 0,

382 subjects will receive one 6 mcg dose of Trivalent inactivated influenza vaccine (TIV) intradermally (ID) with the BD ID System on Day 0,

382 subjects will receive one 9 mcg dose of TIV intradermally (ID) with the BD ID System on Day 0,

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 9, 2005
Last Updated
December 4, 2014
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00170547
Brief Title
Comparison of Delivery Routes of Flu Vaccine in Adults
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
February 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
inactivated, trivalent, influenza, vaccine, Fluzone

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1597 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 3
Arm Type
Experimental
Arm Description
382 subjects will receive one 3 mcg dose of Fluzone intradermally using the Mantoux technique on Day 0,
Arm Title
Group 4
Arm Type
Experimental
Arm Description
382 subjects will receive one 15 mcg dose Fluzone vaccine intramuscularly (IM) on Day 0,
Arm Title
Group 1
Arm Type
Experimental
Arm Description
382 subjects will receive one 6 mcg dose of Trivalent inactivated influenza vaccine (TIV) intradermally (ID) with the BD ID System on Day 0,
Arm Title
Group 2
Arm Type
Experimental
Arm Description
382 subjects will receive one 9 mcg dose of TIV intradermally (ID) with the BD ID System on Day 0,
Intervention Type
Biological
Intervention Name(s)
Trivalent inactivated influenza vaccine
Intervention Description
A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain.. Group 4: 382 subjects receive Fluzone 15 mcg IM on day 0
Intervention Type
Biological
Intervention Name(s)
Trivalent inactivated influenza vaccine
Intervention Description
A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain. Group 1: 382 subjects receive 6 mcg ID with BD system. Group 2: 382 subjects receive 9 mcg ID with BD system, all doses on day 0.
Intervention Type
Biological
Intervention Name(s)
Trivalent inactivated influenza vaccine
Intervention Description
A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain..Group 3: 382 subjects receive 3 mcg Fluzone ID using Mantoux technique on day 0.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305-2200
Country
United States
Facility Name
UCLA Center For Vaccine Research
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
University of Iowa - Vaccine Research & Education Unit
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-2600
Country
United States
Facility Name
University of Maryland Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Saint Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases
City
Rochester
State/Province
New York
ZIP/Postal Code
14642-0001
Country
United States
Facility Name
Duke Health Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Comparison of Delivery Routes of Flu Vaccine in Adults

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