Trivalent rHA Dose Escalation Study in Elderly Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00170443
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : August 12, 2011
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
This study will compare the safety and immunogenicity of three different dose levels of an experimental recombinant influenza HA protein vaccine to a standard inactivated influenza vaccine in heallthy elderly subjects ages 65-80. Blood and nasal secretions for assessment of antibody responses will be obtained from all subjects prior to and one month after vaccination.

Condition or disease Intervention/treatment Phase
Influenza Biological: rHAO Trivalent Influenza Vaccine Phase 2

Detailed Description:
Approximately 400 healthy, ambulatory adults ages 65-80 will be randomized into one of four study groups to receive a single immunization of a licensed trivalent inactivated influenza vaccine or one of three dose levels of an investigatioanl trivalent recombinant influenza HA protein vaccine. The study will be conducted in 2 stages. In the first stage, 80 subjects will be randomized (20 per group) and receive one vaccination on Day 0. Safety will be evaluated after Stage 1 subjects have completed a 7 day follow-up. Enrollment of Stage 2 subjects will begin after the safety data for Stage 1 has been reviewed. In Stage 2, 320 subjects will be randomized (80 per group) and receive one vaccination on Day 0. Blood and nasal secretions will be collected prior to an approximately one month after vaccination to assess antibody responses.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 399 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Phase II Evaluation of the Reactogenicity and Immunogenicity of Different Doses of Intramuscular Trivalent Baculovirus-expressed Influenza HA Vaccine in Healthy Elderly Adults
Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Medically stable adult age 65 -80.
  • Able to give informed consent.
  • Able to comply with all study procedures.
  • Community dwelling.

Exclusion Criteria:

  • History of immunodeficiency or treatment with immunosuppressive medications. (use of inhaled steroids or of topical steroids is not considered immunosuppressive).
  • Allergy to eggs, egg proteins, thimerosal, or other vaccine components.
  • Acute febrile illness or upper respiratory tract illness within 72 hours of vaccination.
  • Life expectancy less than 6 months.
  • Use of experimental vaccines or medications within one month of study entry.
  • Receipt of parenteral immunoglobulin within one month of study entry.
  • Any acute or chronic condition which in the opinion of the investigator would render vaccination unsafe or interfere with the evaluation of response.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00170443

United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

Responsible Party: Robert Johnson, HHS/NIAID/DMID Identifier: NCT00170443     History of Changes
Other Study ID Numbers: 03-119
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: August 12, 2011
Last Verified: April 2006

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Influenza, Baculovirus, Immunogenicity, Geriatrics

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs