Immunogenicity of High-dose Inactivated, Split-virion Influenza Vaccine Versus Standard Fluzone Vaccine in the Elderly

NCT ID: NCT00391053

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 3851 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-02-29

Brief Summary

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.

Conditions

Orthomyxoviridae Infection; Influenza; Myxovirus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Study Group 1

Participants will receive the High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1

Group Type: EXPERIMENTAL

High-Dose Inactivated, Split-Virion Influenza Vaccine

Intervention Type: BIOLOGICAL

0.5 mL, IM

Study Group 2

Participants will receive the High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2

Group Type: EXPERIMENTAL

High-Dose Inactivated, Split-Virion Influenza Vaccine

Intervention Type: BIOLOGICAL

0.5 mL, IM

Study Group 3

Participants will receive the High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3

Group Type: EXPERIMENTAL

High-Dose Inactivated, Split-Virion Influenza Vaccine

Intervention Type: BIOLOGICAL

0.5 mL, IM

Group 4

Participants will receive the Standard Fluzone® vaccine

Group Type: ACTIVE_COMPARATOR

Inactivated, Split-Virion Influenza Vaccine

Intervention Type: BIOLOGICAL

0.5 mL, IM

Interventions

High-Dose Inactivated, Split-Virion Influenza Vaccine

0.5 mL, IM

Intervention Type: BIOLOGICAL

High-Dose Inactivated, Split-Virion Influenza Vaccine

0.5 mL, IM

Intervention Type: BIOLOGICAL

High-Dose Inactivated, Split-Virion Influenza Vaccine

0.5 mL, IM

Intervention Type: BIOLOGICAL

Inactivated, Split-Virion Influenza Vaccine

0.5 mL, IM

Intervention Type: BIOLOGICAL

Other Intervention Names

Fluzone® High-Dose; Fluzone® High-Dose; Fluzone® High-Dose; Fluzone® 2006-2007 formulation

Eligibility 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 intramuscular (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 ≥ 99.5ºF [≥ 37.5ºC]) 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

Mesa, Arizona, United States

Phoenix, Arizona, United States

Tempe, Arizona, United States

Tucson, Arizona, United States

San Diego, California, United States

Stratford, Connecticut, United States

Clearwater, Florida, United States

Coral Gables, Florida, United States

Orlando, Florida, United States

Pembroke Pines, Florida, United States

Wichita, Kansas, United States

Rockville, Maryland, United States

Rochester, Minnesota, United States

Kansas City, Missouri, United States

St Louis, Missouri, United States

Endwell, New York, United States

Rochester, New York, United States

Cary, North Carolina, United States

Raleigh, North Carolina, United States

Downington, Pennsylvania, United States

Erie, Pennsylvania, United States

Warwick, Rhode Island, United States

Dallas, Texas, United States

Plano, Texas, United States

West Jordan, Utah, United States

Norfolk, Virginia, United States

Richmond, Virginia, United States

Marshfield, Wisconsin, United States

Countries

United States

References

Falsey AR, Treanor JJ, Tornieporth N, Capellan J, Gorse GJ. Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older. J Infect Dis. 2009 Jul 15;200(2):172-80. doi: 10.1086/599790.

Reference Type: RESULT

PMID: 19508159 (View on PubMed)

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

FIM05

Identifier Type: -

Identifier Source: org_study_id