Clinical trial NCT00391391: Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Orthomyxoviridae Infection
Influenza
Myxovirus Infection
Keywords: Influenza
Orthomyxoviruses
Inactivated Split-virion influenza vaccine
Infants
children.
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-10-24
Enrollment: 520
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
timeFrame: Day 0 and Day 28 post-vaccination
Secondary outcomes:
measure: 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
timeFrame: Day 28 post-vaccination
measure: Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
timeFrame: Day 28 post-vaccination
measure: Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
timeFrame: Day 28 post-vaccination
measure: 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.
timeFrame: Day 0 to Day 7 post-vaccination
measure: 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
timeFrame: Day 0 to Day 7 post-vaccination
Other outcomes:
Locations:
city: Harrisburg
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Trumann
country: United States
state: Arkansas
city: Bellflower
country: United States
state: California
city: Downey
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Paramount
country: United States
state: California
city: Owensboro
country: United States
state: Kentucky
city: Bossier City
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Brainerd
country: United States
state: Minnesota
city: Cleveland
country: United States
state: Ohio
city: Erie
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Uniontown
country: United States
state: Pennsylvania
city: Wexford
country: United States
state: Pennsylvania
city: Fort Worth
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: