Study of Fluzone® Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route) Among Adults
Safety and Immunogenicity Among Adults of Fluzone®, Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route)
2 other identifiers
interventional
300
1 country
6
Brief Summary
The aim of the study is to evaluate the safety and immunogenicity of the 2011-2012 formulation of Fluzone and Fluzone High-Dose vaccines in participants aged 65 years and older. Objectives:
- To describe the safety of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥ 65 years of age.
- To describe the immunogenicity of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥ 65 years of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2011
Shorter than P25 for phase_4
6 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
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 7, 2011
CompletedFirst Posted
Study publicly available on registry
September 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
May 16, 2013
CompletedMay 27, 2013
May 1, 2013
5 months
September 7, 2011
March 18, 2013
May 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine
Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 solicited reactions were defined as: Fever ≥ 39.0°C; Pain, Headache, Malaise and Myalgia, significant, prevents daily activities; Erythema and Swelling \> 100 mm.
Day 0 to up to Day 28 post-vaccination
Other Outcomes (3)
Geometric Mean Titers of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine.
Day 21 post-vaccination
Number of Participants With Seroconversion Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine
Day 21 post-vaccination
Geometric Mean of Titer Ratios (GMTR) of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine.
Day 21 post-vaccination
Study Arms (2)
Fluzone® Vaccine Group
EXPERIMENTALParticipants will receive the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation
Fluzone® High-Dose Vaccine Group
ACTIVE COMPARATORParticipants will receive the Influenza Virus Vaccine, Fluzone® High-Dose 2011-2012 Formulation.
Interventions
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Eligibility Criteria
You may qualify if:
- Informed consent form (ICF) has been signed and dated.
- Able to attend all scheduled visits and to comply with all trial procedures.
You may not qualify if:
- History of serious adverse reaction to any influenza vaccine.
- Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before the 2nd visit.
- Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study, unless no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the subject would complete safety surveillance for the present study.
- Influenza vaccination in the 6 months preceding enrollment in the study.
- Known systemic hypersensitivity to eggs, chicken proteins, latex, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone or Fluzone High-Dose vaccine or to a vaccine containing any of the same substances (the complete list of vaccine components is included in the Investigator's Brochure and/or the package insert) .
- Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
- Thrombocytopenia, which may be a contraindication for intramuscular (IM) vaccination, at the discretion of the Investigator.
- Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.
- Personal history of Guillain-Barré syndrome.
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
- Seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, as reported by the subject.
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
- Current alcohol or drug addiction that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.
- Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of vaccination. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
Colorado Springs, Colorado, 80920, United States
Unknown Facility
Council Buffs, Iowa, 51503, United States
Unknown Facility
Metairie, Louisiana, 70006, United States
Unknown Facility
Springfield, Missouri, 65804, United States
Unknown Facility
Bensalem, Pennsylvania, 19020, United States
Unknown Facility
Austin, Texas, 78705, United States
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 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2011
First Posted
September 8, 2011
Study Start
September 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
May 27, 2013
Results First Posted
May 16, 2013
Record last verified: 2013-05