Eldery High Dose TIV 2005

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00115531
First received: June 22, 2005
Last updated: August 22, 2013
Last verified: February 2007
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: Higher Dose TIV
Biological: TIV
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: Comparisons of the Reactogenicity and Immunogenicity in Ambulatory Elderly Subjects of a Standard-Dose Fluzone® (15 µg HA/Virus Strain) and a High-Dose (60 µg HA/Virus Strain) of a Trivalent Inactivated Influenza Virus Vaccine

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment: 414
Study Start Date: April 2005
Estimated Study Completion Date: November 2005
Detailed Description:

Influenza is a common respiratory infection caused by several related viruses. Epidemics of influenza occur each winter and are responsible for an average of about 36,000 deaths each year in the United States. Most of these deaths occur among elderly persons and among people of all ages who suffer from chronic diseases, particularly of the lungs and the heart. Current influenza virus vaccines protect elderly persons against influenza, but not as well as desired. One consideration for trying to increase protection is to increase the vaccine dose, but there is some concern that increasing the dose may increase reactions to the vaccine (such as sore arm, aches, or fever). One of the vaccine manufacturers has prepared an experimental influenza virus vaccine with a dose that is higher than the currently used dose. A previous study with the same high dose of the vaccine showed that it was well tolerated with only increased reactions at the injection site compared to the usual vaccine. Since the study, the high-dose vaccine has also been made without preservative (thimerosal) and gelatin, which are in the standard vaccine. It is expected that this vaccine can be given with little reaction, but this needs to be determined. It also needs to be shown whether such a vaccine stimulates higher levels of infection-fighting proteins (or antibodies) in the blood than standard doses of influenza vaccine. The purpose of this research is to compare reactions and antibody responses following standard flu vaccine to those following the experimental vaccine. 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. This study is linked to DMID protocol 05-0028.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for study participation:

  • 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.

Exclusion Criteria:

Subjects must not meet any of the following exclusion criteria in order to be eligible for participation in this study:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115531

Locations
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, 63131
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
  More Information

No publications provided by National Institute of Allergy and Infectious Diseases (NIAID)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00115531     History of Changes
Other Study ID Numbers: 04-100
Study First Received: June 22, 2005
Last Updated: August 22, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Elderly, influenza, vaccine, parent protocol

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 July 20, 2014