Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by (Responsible Party):	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00391391

Purpose

Primary Objective:

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.

Condition	Intervention	Phase
Orthomyxoviridae Infection Influenza Myxovirus Infection	Biological: Split, Inactivated, Trivalent Influenza Vaccine Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Immunogenicity and Safety of a Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Standard Fluzone® in Healthy Infants and Young Children.

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine [ Time Frame: Day 0 and Day 28 post-vaccination ] [ Designated as safety issue: No ]
Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.

Secondary Outcome Measures:

Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]
Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]
Seroprotection was defined as participants achieving a post-dose antibody titers ≥40.

Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]
Seroconversion was defined as the conversion to a post-vaccination titer of ≥ 40 for subjects with pre-vaccination titer < 10, or at least a 4-fold increase in post vaccination titer for subjects with pre vaccination titer ≥ 10.
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months. [ Time Frame: Day 0 to Day 7 post-vaccination ] [ Designated as safety issue: No ]
Solicited injection site reactions: Tenderness, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability.
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds [ Time Frame: Day 0 to Day 7 post-vaccination ] [ Designated as safety issue: No ]
Solicited injection site reactions: Pain, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia.

Enrollment:	520
Study Start Date:	October 2006
Study Completion Date:	October 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Split, Inactivated, Trivalent Influenza Vaccine	Biological: Split, Inactivated, Trivalent Influenza Vaccine Vaccine (infant dose)
Experimental: 2 Split, Inactivated, Trivalent Influenza Vaccine	Biological: Split, Inactivated, Trivalent Influenza Vaccine Vaccine (children dose)
Active Comparator: 3 Split, Inactivated, Trivalent Influenza Vaccine	Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation) Vaccine (infant dose) Other Name: Fluzone® 2006/2007 Formulation.
Active Comparator: 4 Split, Inactivated, Trivalent Influenza Vaccine	Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation) Vaccine (children dose) Other Name: Fluzone® 2006/2007 Formulation.

Eligibility

Ages Eligible for Study:	6 Months to 8 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria :

Aged 6 months to 8 years but not yet 9 years on the day of inclusion.
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 :

Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391391

Locations

United States, Arkansas

Harrisburg, Arkansas, United States, 72432

Little Rock, Arkansas, United States, 72205

Trumann, Arkansas, United States, 72472
United States, California

Bellflower, California, United States, 90706

Downey, California, United States, 90241

Fountain Valley, California, United States, 92708

Paramount, California, United States, 90723
United States, Kentucky

Owensboro, Kentucky, United States, 42303
United States, Louisiana

Bossier City, Louisiana, United States, 71111

Shreveport, Louisiana, United States, 71105
United States, Minnesota

Brainerd, Minnesota, United States, 56401
United States, Ohio

Cleveland, Ohio, United States, 44121
United States, Pennsylvania

Erie, Pennsylvania, United States, 16505

Pittsburgh, Pennsylvania, United States, 15277

Uniontown, Pennsylvania, United States, 15401

Wexford, Pennsylvania, United States, 15090
United States, Texas

Fort Worth, Texas, United States, 76107
United States, Utah

Salt Lake City, Utah, United States, 84109

Salt Lake City, Utah, United States, 84121

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Director

Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00391391 History of Changes
Other Study ID Numbers:	FID07
Study First Received:	October 23, 2006
Results First Received:	October 12, 2011
Last Updated:	November 21, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Influenza
Orthomyxoviruses
Inactivated Split-virion influenza vaccine
Infants
children.

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 12, 2012