Immunogenicity and Safety of Different Doses of Fluzone® Influenza

NCT00253734 | Completed Phase 2

• 1 other identifier: 05-0109
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to find out if giving the smaller dose of flu vaccine under the skin generates antibodies against flu compared to giving the vaccine the usual way, as a shot in the arm. If using smaller doses in this manner is effective, the current supply of vaccine could be used to make more doses to give to more people. About 217 healthy adults, 18 to 49 years of age, will participate. The study will be conducted at one site in the United States and subjects are expected to participate for about 6 months. Blood samples will be taken to assess the immune system response. Local and systemic safety will be evaluated in the 28 days following vaccination.

Conditions

Influenza

Keywords

Influenza

Outcome Measures

Primary Outcomes (1)

• Immunogenicity evaluated by haemagglutination-inhibition assay (HAI).

  Blood sampled at day 28 +/- 3 days post vaccination.

Secondary Outcomes (1)

• Safety: solicited adverse events (AE)-reactogenicity following each vaccination (local and systemic reactions); unsolicited adverse events, and serious AEs.

  Adverse events-reactogenicity following each vaccination. Unsolicited AEs through day 28 +/- 3. Serious AEs occurring during the length of the study.

Study Arms (7)

4

ACTIVE COMPARATOR

31 subjects to receive 15 mcg of TIV administered intramuscularly.

Biological: Fluzone® (IM)

2

EXPERIMENTAL

31 subjects to receive 6 mcg of TIV administered intradermally.

Biological: Fluzone®

1

EXPERIMENTAL

31 subjects to receive 9 mcg of TIV administered intradermally.

Biological: Fluzone®

3

EXPERIMENTAL

31 subjects to receive 3 mcg of TIV administered intradermally.

Biological: Fluzone®

5

ACTIVE COMPARATOR

31 subjects to receive 9 mcg of TIV administered intramuscularly.

Biological: Fluzone® (IM)

7

ACTIVE COMPARATOR

31 subjects to receive 3 mcg of TIV administered intramuscularly.

Biological: Fluzone® (IM)

6

ACTIVE COMPARATOR

31 subjects to receive 6 mcg of TIV administered intramuscularly.

Biological: Fluzone® (IM)

Interventions

Fluzone® (IM) BIOLOGICAL

15, 9, 6, or 3 mcg of standard trivalent inactivated influenza vaccine (TIV) administered by the standard intramuscular route.

4; 5; 6; 7

Fluzone® BIOLOGICAL

9, 6, or 3 mcg of standard trivalent inactivated influenza vaccine (TIV) administered by intradermal route (Mantoux technique).

1; 2; 3

Eligibility Criteria

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

You may qualify if:

• Subject is healthy, as determined by medical history and clinical assessment before entering the study.
• Between the ages of 18 and 49 (greater than or equal to 18 and less than 50)
• Provides written informed consent
• Able to attend all scheduled visits and to comply with all trial procedures
• For a woman, menopausal or surgically sterile or negative serum/urine pregnancy test within 24 hours prior to the time of vaccination.

You may not qualify if:

• Breast-feeding or pregnant.
• History of receiving 2003-2004, 2004-2005 or 2005-2006 influenza vaccine.
• Known allergy to eggs or other components of the vaccine (e.g., thimerosal).
• History of a severe reaction following influenza vaccination, systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing the same substances.
• History of Guillain-Barre Syndrome.
• Immunosuppression as a result of underlying illness or treatment.
• Use of oral steroids, parenteral steroids, or high-dose inhaled steroids (\>800 mcg per day of beclomethasone dipropionate or equivalent) within 1 month prior to vaccination.
• Use of other immunosuppressive or cytotoxic drugs or radiation therapy within the six months prior to vaccination.
• Active neoplastic disease or history of any hematologic malignancy in the past 5 years (except localized skin or prostate cancer that is stable in the absence of therapy).
• Acute or chronic condition that (in the opinion of the Investigator) would render vaccination unsafe or would interfere with the evaluation of responses including, but not limited to the following: known chronic liver disease, significant renal disease, oxygen-dependent chronic lung disease, New York Heart Association Functional Class III or IV, unstable or progressive neurologic disorder, insulin-treated diabetes mellitus.
• Use of experimental vaccines or medications within the month prior to study entry, or expected use of experimental vaccines or medications during the entire study period after inoculation with study vaccine.
• Use of experimental devices or participation in a medical procedure trial within the month prior to study entry, or expected use of experimental devices or participation in a medical procedure trial during the entire study period.
• \. Receipt of immunoglobulin or other blood product within 3 months prior to enrollment.
• Receipt of other licensed vaccines within the preceding 4 weeks or expected to receive a licensed vaccine within 28 days (prior to visit 2) following trial vaccination.
• Subject is enrolled in a conflicting clinical trial.

Sponsors & Collaborators

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

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

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 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2005
• First Posted: November 15, 2005
• Study Start: November 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: November 1, 2006
• Last Updated: June 3, 2013

Record last verified: 2008-07

Locations

US (1)