Clinical trial NCT00858468: Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 Months of Age
Official title: Proof of Concept Study of the Safety and Immunogenicity of Influenza Virus Vaccine Fluzone® 2004-2005 Among Healthy Children 2 Months vs 6 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Influenza
Keywords: Influenza
Influenza vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-03-09
Enrollment: 394
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Primary Objective:

To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the package insert for vaccine-naïve young children) to the investigational and control groups.

Observational Objective:

To describe the percentage of protective Hemagglutination Inhibition (HAI) antibody titers (following a 2-dose Fluzone® immunization series) to each of the 3 vaccine antigens among the investigational and control groups.

Detailed description: This is an observational and descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children aged 6 to 12 weeks (the investigational group, also referred to as the 2-month-old group) versus children aged 24 to 36 weeks (the control group, also referred to as the 6-month-old group). The study is not designed to achieve any preset statistical power, and no hypotheses will be tested.

Eligibility criteria: Inclusion Criteria :

* Aged 42 to 84 days (6 to 12 weeks) or 24 to 36 weeks on the day of inclusion.
* Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg.
* Considered to be in good health on the basis of reported medical history and history-directed physical examination.
* Available for the duration of the study.
* Parent/guardian willing and able to provide informed consent.
* Parent/guardian able to attend all scheduled visits and comply with all trial procedures.
* Willingness to permit venipuncture or heel stick for purposes of collecting a blood sample.

Exclusion Criteria :

* Reported allergy to egg proteins, chicken proteins or any other constituent of the vaccine.
* Previous history of influenza vaccination or documented history of influenza infection.
* Receipt of any vaccine in the 7 days prior to enrollment.
* An acute illness with fever (rectal temperature ≥ 38.0 °C \[or ≥ 100.4 °F\]) in the 72 hours preceding enrollment in the trial (defer enrollment).
* Known bleeding disorder.
* Participation in any other clinical trial within 30 days prior to enrollment, or planned participation in another clinical trial prior to termination of the subject's participation in this study.
* Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
* Personal or immediate family history of congenital immune deficiency.
* Developmental delay, neurologic disorder, or seizure disorder.
* Chronic medical, congenital or developmental disorder that could interfere with trial conduct or completion.
* Known HIV-positive or HBsAg-positive mother.
* Known HIV, hepatitis B (HBsAg), or hepatitis C infection.
* Blood or blood-derived products received in the past 2 months.
* Prior history of Guillain-Barré syndrome.
* Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.

Primary outcomes:
measure: Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation.
timeFrame: Day 0 to Day 7 post-vaccination
Secondary outcomes:
Other outcomes:
measure: Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titer ≥ 40 Post-vaccination With Fluzone® (Seroprotection).
timeFrame: 21 days post-vaccination 2
measure: Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion).
timeFrame: 21 days post-vaccination 2
measure: Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine.
timeFrame: 21 days post-vaccination 2
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Marietta
country: United States
state: Georgia
city: Durham
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Norfolk
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: