Immunogenicity of High-dose Inactivated, Split-virion Influenza Vaccine Versus Standard Fluzone Vaccine in the Elderly
Phase III Lot Consistency, Immunogenicity and Safety Study of Three Lots of Fluzone High Dose Vaccine Compared With One Lot of Standard Fluzone® in Adults ≥ 65 Years of Age.
1 other identifier
interventional
3,851
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2006
Shorter than P25 for phase_3
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 20, 2006
CompletedFirst Posted
Study publicly available on registry
October 23, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
April 30, 2010
CompletedApril 14, 2016
April 1, 2016
9 months
October 20, 2006
January 14, 2010
April 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Pre- and Post-vaccination With Fluzone® High Dose or Standard Fluzone® Vaccines.
Antibodies against each of three Influenza antigens (virus) in Fluzone® High-Dose and Standard Fluzone® vaccines (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) were determined by the Hemagglutination inhibition assay method.
Day 0 and Day 28 Post-vaccination
Percentage of Participants With Seroconversion Post-vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines.
Seroconversion was defined as a Hemagglutination Inhibition Antibody Titers of Titer ≥40 (1/dil) on Day 28 if pre-vaccination (Day 0) titer \<10 (1/dil); or a four-fold increase of titer on Day 28, if pre-vaccination (Day 0) titer is ≥10 (1/dil) for each of the three Influenza vaccine antigens (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia).
Day 28 Post-vaccination
Secondary Outcomes (2)
Percentage of Participants With Seroprotection Pre- and Post-Vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines.
Day 0 and Day 28 Post-vaccination
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination
Day 0 to Day 7 Post-vaccination
Study Arms (4)
Study Group 1
EXPERIMENTALParticipants will receive the High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1
Study Group 2
EXPERIMENTALParticipants will receive the High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2
Study Group 3
EXPERIMENTALParticipants will receive the High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3
Group 4
ACTIVE COMPARATORParticipants will receive the Standard Fluzone® vaccine
Interventions
0.5 mL, IM
0.5 mL, IM
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Unknown Facility
Mesa, Arizona, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Tempe, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Stratford, Connecticut, United States
Unknown Facility
Clearwater, Florida, United States
Unknown Facility
Coral Gables, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Pembroke Pines, Florida, United States
Unknown Facility
Wichita, Kansas, United States
Unknown Facility
Rockville, Maryland, United States
Unknown Facility
Rochester, Minnesota, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Endwell, New York, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Cary, North Carolina, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Downington, Pennsylvania, United States
Unknown Facility
Erie, Pennsylvania, United States
Unknown Facility
Warwick, Rhode Island, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Plano, Texas, United States
Unknown Facility
West Jordan, Utah, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Marshfield, Wisconsin, United States
Related Publications (1)
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.
PMID: 19508159RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2006
First Posted
October 23, 2006
Study Start
October 1, 2006
Primary Completion
July 1, 2007
Study Completion
February 1, 2008
Last Updated
April 14, 2016
Results First Posted
April 30, 2010
Record last verified: 2016-04