Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children
NCT ID: NCT00391391
Last Updated: 2011-12-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
520 participants
INTERVENTIONAL
2006-10-31
2007-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.
Secondary Objectives:
* To describe the immunogenicity of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.
* To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Split, Inactivated, Trivalent Influenza Vaccine
Split, Inactivated, Trivalent Influenza Vaccine
Vaccine (infant dose)
2
Split, Inactivated, Trivalent Influenza Vaccine
Split, Inactivated, Trivalent Influenza Vaccine
Vaccine (children dose)
3
Split, Inactivated, Trivalent Influenza Vaccine
Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)
Vaccine (infant dose)
4
Split, Inactivated, Trivalent Influenza Vaccine
Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)
Vaccine (children dose)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Split, Inactivated, Trivalent Influenza Vaccine
Vaccine (infant dose)
Split, Inactivated, Trivalent Influenza Vaccine
Vaccine (children dose)
Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)
Vaccine (infant dose)
Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)
Vaccine (children dose)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subject is healthy, as determined by medical history.
* Institution Review Board (IRB)-approved informed assent form signed by eligible subject (if required by local regulations) and/or an IRB-approved informed consent form signed by the subject's parent(s) or legal representative (and by an independent witness if required by local regulations).
* Parent or legal guardian willing and able to attend (bring subject) to all scheduled visits and comply with all trial procedures.
Exclusion Criteria
* Planned participation in another clinical trial during the present trial period.
* Personal or family history of Guillain-Barré Syndrome.
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
* Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a vaccine containing the same substances.
* Chronic illness at a stage that could interfere with trial conduct or completion
* Received blood or blood-derived products in the previous 3 months.
* Any vaccination in the 4 weeks preceding or following the trial vaccinations (Subjects can take standard childhood vaccination(s) following Visit 3 blood draw).
* Known current human immunodeficiency virus (HIV), hepatitis B (HBsAg) or hepatitis C infection or seropositivity.
* Known thrombocytopenia or bleeding disorder contraindicating IM vaccination.
* Acute medical illness, with or without fever, within the last 72 hours or an oral temperature ≥ 37.5 °C (99.5 °F) or rectal temperature of ≥ 38°C (100.4 °F) at the time of enrollment.
* History of seizures.
* Received antibiotics therapy within 72 hours preceding the trial vaccination.
* Received any allergy shots in the 7-day period preceding trial vaccination and/or scheduled to receive any allergy shots in the 7-day period after trial vaccination.
* Any condition, which in the opinion of the investigator would pose a health risk to the participant.
6 Months
8 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Harrisburg, Arkansas, United States
Little Rock, Arkansas, United States
Trumann, Arkansas, United States
Bellflower, California, United States
Downey, California, United States
Fountain Valley, California, United States
Paramount, California, United States
Owensboro, Kentucky, United States
Bossier City, Louisiana, United States
Shreveport, Louisiana, United States
Brainerd, Minnesota, United States
Cleveland, Ohio, United States
Erie, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Uniontown, Pennsylvania, United States
Wexford, Pennsylvania, United States
Fort Worth, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FID07
Identifier Type: -
Identifier Source: org_study_id