Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine
Safety and Immunogenicity of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine in Healthy Adults
1 other identifier
interventional
375
1 country
6
Brief Summary
Following the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity using adjuvants were initiated. The present study is part of this endeavor. It is primarily a formulation/dose-finding study with a secondary aim at generating safety and immunogenicity data for the final formulation for the development of a pre-pandemic vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2008
Typical duration for phase_1
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
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 22, 2008
CompletedFirst Posted
Study publicly available on registry
April 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedApril 17, 2012
April 1, 2012
1.4 years
April 22, 2008
April 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To provide information concerning the safety after primary administration of A/H1N1 vaccine
6 months post-vaccination
Study Arms (9)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
EXPERIMENTAL5
EXPERIMENTAL6
EXPERIMENTAL7
ACTIVE COMPARATOR8
ACTIVE COMPARATOR9
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Provides signed informed consent prior to study procedures.
- Able to attend all scheduled visits and 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 the first vaccination, until at least 4 weeks after last 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
- For a woman of child-bearing potential, known pregnancy or positive serum/urine pregnancy test
- Breast feeding woman
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the (first) trial vaccination
- Planned participation in another clinical trial during the present trial period
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, oral, parenteral, or inhaled steroids
- Has an acute or chronic medical illness or any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or would interfere with the evaluation of responses or render the subject unable to meet the requirements of the protocol
- Known or suspected current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
- History of receipt of blood or immunoglobulin or other blood-derived products within the 3 months prior to enrollment in this study that might interfere with the assessment of immune response
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
- Planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination
- Known Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or Hepatitis C seropositivity
- Personal or family history of Guillain-Barré Syndrome
- Active neoplastic disease or a history of any hematologic malignancy
- Previous participation in a pandemic flu trial
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (6)
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
South Miami, Florida, 33143, United States
Unknown Facility
Springfield, Missouri, 65802, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Cincinnati, Ohio, 45227, United States
Unknown Facility
Knoxville, Tennessee, 37920, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Sanofi Pasteur, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2008
First Posted
April 23, 2008
Study Start
April 1, 2008
Primary Completion
September 1, 2009
Study Completion
August 1, 2010
Last Updated
April 17, 2012
Record last verified: 2012-04