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Immunogenicity of High-Dose Inactivated, Split-Virion Influenza Vaccine Versus Standard Fluzone Vaccine in the Elderly
This study has been completed.
First Received: October 20, 2006   Last Updated: May 12, 2008   History of Changes
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00391053
  Purpose

Compared to young adults, the elderly mount a lower antibody response to vaccination. Thus, improvement of the immune response to influenza vaccination in this age group, which is at higher risk for influenza-related morbidity and mortality, represents an important unmet need.

Primary Objectives:

Immunogenicity:

  • To demonstrate lot consistency of the Fluzone High Dose (Fluzone HD) manufacturing process through evaluation of the immune responses elicited by three different lots.
  • To demonstrate the superiority of Fluzone HD vaccine compared to standard-dose Fluzone® vaccine.

Secondary Objectives:

Immunogenicity:

  • To describe the seroprotection of Fluzone HD compared to that of standard dose Fluzone® vaccine.

Safety:

  • To describe the safety profile of Fluzone HD, in terms of solicited -, unsolicited adverse and serious adverse events post-vaccination.
  • To describe clinical information on some additional defined criteria during the six months following vaccination.

Condition Intervention Phase
Orthomyxoviridae Infection
Influenza
Myxovirus Infection
Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine
Biological: Inactivated, Split-Virion Influenza Vaccine
Phase III

MedlinePlus related topics: Flu
Drug Information available for: Fluvirin Influenza Vaccines
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • To provide information concerning the immunogenicity of High-Dose Inactivated, Split-Virion Influenza Vaccine [ Time Frame: 28 days post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To provide information concerning the safety of High-Dose Inactivated, Split-Virion Influenza Vaccine [ Time Frame: 6 months post-vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 3876
Study Start Date: October 2006
Study Completion Date: February 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1
Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine
0.5 mL, IM
2: Experimental
High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2
Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine
0.5 mL, IM
3: Experimental
High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3
Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine
o.5 mL, IM
4: Active Comparator Biological: Inactivated, Split-Virion Influenza Vaccine
0.5 mL, IM

  Eligibility

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

Inclusion Criteria:

  • Aged >= 65 years on the day of vaccination.
  • Informed consent form signed.
  • Medically stable. (Subjects may have underlying chronic conditions such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, as long as their symptoms/signs are controlled. If they are on medication for a condition, the medication dose must have been stable for at least 3 weeks preceding vaccination.)
  • Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

  • Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to the standard-dose Fluzone® vaccine or a vaccine containing any of the same substances.
  • Congenital or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months.
  • Systemic corticosteroid therapy, as follows:

Continuous use with a dosage equivalent to >15 mg/day of oral prednisone for 90 days preceding vaccination.

Sporadic use with a dosage equivalent to > 40 mg/day of oral prednisone for > 14 consecutive days in the 90 days preceding vaccination.

Note:Use of topical or inhalant corticosteroids is acceptable.

  • Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, as well as subjects who have a history of neoplastic disease and who have been disease-free for >= 5 years).
  • Current alcohol abuse or drug addiction that in the opinion of the investigator may interfere with the subject's ability to comply with trial procedures.
  • Receipt of blood or blood-derived products in the past three months.
  • Participation in a trial of a high-dose influenza vaccine in the past 12 months.
  • Receipt of influenza vaccine in the past six months.
  • Receipt of any other vaccine in the past four weeks.
  • Planned receipt of any other vaccine in the four weeks following the trial vaccination.
  • Participation in another clinical trial in the past four weeks.
  • Planned participation in another clinical trial during the present trial period.

Note:Concomitant participation in an observational trial (not involving drugs, vaccines, or medical devices) is acceptable.

  • Thrombocytopenia or bleeding disorder contraindicating IM vaccination.
  • History of Guillain-Barré syndrome.
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
  • An acute febrile illness (oral temperature >= 99.5 oF [>= 37.5 oC]) within 24 hours prior to vaccination. If this contraindication exists, vaccination will be deferred until the participant has been afebrile for at least 24 hours.
  • Signs and symptoms of an acute infectious respiratory illness. If this exists, vaccination will be deferred until the symptoms resolve.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00391053

  Show 28 Study Locations
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Clinical Trials sanofi pasteur
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi Pasteur, Inc. ( Medical Monitor )
Study ID Numbers: FIM05
Study First Received: October 20, 2006
Last Updated: May 12, 2008
ClinicalTrials.gov Identifier: NCT00391053     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:
Influenza
Orthomyxoviruses
Inactivated Split-virion influenza vaccine
Adults

Study placed in the following topic categories:
Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:
Virus Diseases
Communicable Diseases
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections
Infection

ClinicalTrials.gov processed this record on May 07, 2009