Study of Inactivated, Split-Virion Influenza Vaccine and Standard Fluzone® Vaccine in Adult and Elderly Subjects
Immunogenicity and Safety of Two Dosages of the Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in the Elderly Compared With Standard Fluzone® in Adults and Elderly Subjects.
1 other identifier
interventional
2,098
1 country
29
Brief Summary
The present formulations are being developed for further study in the elderly population in order to generate additional supporting data. Primary Objective: To demonstrate non-inferiority of post-vaccination immunogenicity of subjects who received either 1 of the 2 investigational formulations of a trivalent inactivated vaccine (TIV) compared to that of the standard Fluzone® in elderly subjects. Secondary Objectives: Immunogenicity To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone®. Safety: To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2007
Shorter than P25 for phase_2
29 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, 2007
CompletedFirst Submitted
Initial submission to the registry
October 29, 2007
CompletedFirst Posted
Study publicly available on registry
October 30, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
November 24, 2011
CompletedMay 16, 2016
April 1, 2016
8 months
October 29, 2007
October 13, 2011
April 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
Serum antibody titers for the Influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by hemagglutinin inhibition (HAI) assay.
Day 0 and Day 28 post vaccination
Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine
Seroconversion defined as either a pre-vaccination hemagglutination inhibition (HAI) titer \< 1:10 and a post vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four fold increase at one month post-vaccination.
Day 28 post-vaccination
Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
Seroprotection was defined as a Hemagglutination inhibition (HAI) titer ≥ 1:40
Day 0 and Day 28 post-vaccination
Secondary Outcomes (1)
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
Days 0 through 7 post-vaccination
Study Arms (5)
Influenza Virus Vaccine Formulation 1
EXPERIMENTALInfluenza Virus Vaccine Formulation 1
Influenza Virus Vaccine Formulation 2
EXPERIMENTALInfluenza Virus Vaccine Formulation 2
Fluzone® Elderly Group
ACTIVE COMPARATORFluzone® High-dose Group
ACTIVE COMPARATORParticipants enrolled at age ≥ 65 years
Fluzone® Adults Group
ACTIVE COMPARATORParticipants enrolled at age 18-49 years.
Interventions
0.1 mL, Intradermal (ID)
0.1 mL, Intradermal (ID)
0.5 mL, Intramuscular (IM)
0.5 mL, Intramuscular (IM)
Eligibility Criteria
You may qualify if:
- Aged ≥ 65 years or aged 18 to 49 years on the day of vaccination.
- Informed consent form signed.
- Medically stable (Subjects may have underlying illnesses 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.
- For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination
You may not qualify if:
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the standard-dose Fluzone® vaccine or to a vaccine containing any of the same substances.
- Known or suspected congenital or acquired immunodeficiency, hepatitis B (HBsAg) or hepatitis C infection or seropositivity immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
- For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test.
- Breast feeding woman.
- 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 use of alcohol or recreational drugs 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 3 months that might interfere with the assessment of immune response.
- Vaccination against influenza in the past 6 months.
- Any vaccination in the 4 weeks preceding the trial vaccination.
- Planned receipt of any other vaccine in the four weeks following the trial vaccination.
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding trial vaccination.
- 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.
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
- Personal or family history of Guillain-Barré Syndrome.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (29)
Unknown Facility
Alabaster, Alabama, United States
Unknown Facility
Mobile, Alabama, United States
Unknown Facility
Chandler, Arizona, United States
Unknown Facility
Mesa, Arizona, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Fountain Valley, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Stanford, Connecticut, United States
Unknown Facility
Pembroke Pines, Florida, United States
Unknown Facility
Pinellas Park, Florida, United States
Unknown Facility
Boise, Idaho, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Wichita, Kansas, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
Springfield, Missouri, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Cary, North Carolina, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Allentown, Pennsylvania, United States
Unknown Facility
Bensalem, Pennsylvania, United States
Unknown Facility
Warwick, Rhode Island, United States
Unknown Facility
Goose Creek, South Carolina, United States
Unknown Facility
Fort Worth, Texas, United States
Unknown Facility
Galveston, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
West Jordan, Utah, United States
Unknown Facility
Marshfield, Wisconsin, United States
Related Publications (1)
Tsang P, Gorse GJ, Strout CB, Sperling M, Greenberg DP, Ozol-Godfrey A, DiazGranados C, Landolfi V. Immunogenicity and safety of Fluzone((R)) intradermal and high-dose influenza vaccines in older adults >/=65 years of age: a randomized, controlled, phase II trial. Vaccine. 2014 May 1;32(21):2507-17. doi: 10.1016/j.vaccine.2013.09.074. Epub 2013 Oct 11.
PMID: 24120672DERIVED
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 2
- 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 29, 2007
First Posted
October 30, 2007
Study Start
October 1, 2007
Primary Completion
June 1, 2008
Study Completion
November 1, 2008
Last Updated
May 16, 2016
Results First Posted
November 24, 2011
Record last verified: 2016-04