Eldery High Dose TIV 2005

NCT00115531 | Completed Phase 2

• 1 other identifier: 04-100
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to compare a new higher-dose influenza virus vaccine to the standard dose vaccine in elderly adults who can walk. Current influenza vaccines protect elderly against viral influenza but not as well as desired. It is expected that the higher doses vaccine can be given with little reaction, but this needs to be tested. Up to 410 people ages 65 years and older will be recruited from the community and from existing volunteer populations. Participants will receive either the high or standard dose injected in the muscle, remain in the clinic for 20 minutes afterward, and maintain a daily memory aid for 7 days. The memory aid will be reviewed by telephone 8-12 days after the injection and return to the clinic or contacted by telephone 6 months after the injection.

Conditions

Influenza

Keywords

Elderly, influenza, vaccine, parent protocol

Study Arms (2)

Arm 1

EXPERIMENTAL

Standard Dose Influenza Vaccine Fluzone® (15 µg HA / viral strain; 45 µg/0.5 mL dose) will be administered to Arm 1: 200 subjects intramuscularly on day 0.

Biological: Trivalent inactivated influenza vaccine

Arm 2

EXPERIMENTAL

High Dose Influenza Fluzone® Vaccine (60 µg HA / viral strain; 180 µg/0.5 mL dose) will be administered to Arm 2: 200 subjects intramuscularly on Day 0.

Biological: Trivalent inactivated influenza vaccine

Interventions

Trivalent inactivated influenza vaccine BIOLOGICAL

Standard Dose Influenza Vaccine Fluzone® (15 µg HA / viral strain; 45 µg/0.5 mL dose) will be administered to Arm 1: 200 subjects intramuscularly on day 0.

Arm 1

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Ambulatory medically stable persons \>= 65 years of age on the date of vaccination
• Provides written informed consent and will be available for all study visits
• Able to understand and comply with planned study procedures
• Subjects will be considered ambulatory if they are not institutionalized, bedridden, or homebound. Medically stable subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, but their symptoms/signs must be controlled with medical therapy. Subjects with acute febrile illnesses \[oral temperature equal to or exceeding 99.5ºF (37.5ºC)\] will be deferred until 3 days after illness resolution.

You may not qualify if:

• Known allergy to eggs or other components of the vaccine (eg, 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-Barré Syndrome;
• Immunosuppression as a result of underlying illness or treatment;
• Use of oral steroids, parenteral steroids, or high-dose inhaled steroids (\> 800 µg 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, including the 6-month follow-up phone call, 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, including the 6-month follow-up phone call, after inoculation with study vaccine;
• 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 1 month (prior to visit 2) following trial vaccination;
• Subject is enrolled in a conflicting clinical trial;
• Thrombocytopenia or bleeding disorder or therapy contraindicating IM vaccination.

Sponsors & Collaborators

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

Study Sites (5)

University of Iowa - Vaccine Research & Education Unit

Iowa City, Iowa, 52242-2600, United States

Location

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Location

Saint Louis University

St Louis, Missouri, 63131, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Chen WH, Cross AS, Edelman R, Sztein MB, Blackwelder WC, Pasetti MF. Antibody and Th1-type cell-mediated immune responses in elderly and young adults immunized with the standard or a high dose influenza vaccine. Vaccine. 2011 Apr 5;29(16):2865-73. doi: 10.1016/j.vaccine.2011.02.017. Epub 2011 Feb 23.

  PMID: 21352939 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2005
• First Posted: June 23, 2005
• Study Start: April 1, 2005
• Study Completion: November 1, 2005
• Last Updated: December 19, 2014

Record last verified: 2007-02

Locations

US (5)