Comparison of Delivery Routes of Flu Vaccine in Adults

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170547
• Other study ID #: 05-0075
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: December 4, 2014
• Start date: September 2005
• Est. completion date: February 2006

Study information

• Verified date: July 2006
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1597
• Est. completion date: February 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Trivalent inactivated influenza vaccine
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
• Trivalent inactivated influenza vaccine
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.
• Trivalent inactivated influenza vaccine
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.

Locations

Country	Name	City	State
United States	University of Maryland Baltimore	Baltimore	Maryland
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Duke Health Center	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	University of Iowa - Vaccine Research & Education Unit	Iowa City	Iowa
United States	Vanderbilt University	Nashville	Tennessee
United States	University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases	Rochester	New York
United States	Saint Louis University	St. Louis	Missouri
United States	Stanford University School of Medicine	Stanford	California
United States	UCLA Center For Vaccine Research	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States,