Clinical trial NCT00831675: Study of Safety and Immunogenicity of Fluzone® in Healthy Children
Official title: Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Influenza Virus Vaccine Fluzone® 2004-2005
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza
Fluzone® vaccine
Infants
Toddlers
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months.

To describe the immunogenicity of the 2004-2005 inactivated, split-virion influenza vaccine Fluzone®, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months

Detailed description: To provide the Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO).

Eligibility criteria: Inclusion Criteria :

* Participant is aged ≥ 6 months to \< 36 months.
* Participant is considered to be in good health on the basis of reported medical history and limited physical examination.
* Participant is available for the duration of the study.
* Parent/guardian is willing and able to provide informed consent.
* Parent/guardian is willing and able to meet protocol requirements.

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.
* An acute illness with or without fever (temperature \> 100.4 °F rectal) in the 72 hours preceding enrollment in the trial (defer enrollment).
* Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude).
* Participation in any other clinical trial within 30 days prior to enrollment up to termination of the subject's participation in the 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.
* Known human immunodeficiency virus (HIV)-positive mother.
* 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.
* Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.

Primary outcomes:
measure: Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation
timeFrame: Days 0-3 Post-dose
Secondary outcomes:
Other outcomes:
measure: Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation
timeFrame: 14 days post-vaccination
measure: Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection)
timeFrame: 14 days post-vaccination
measure: Percentage of Participants With a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroconversion)
timeFrame: Day 14 post-vaccination
Locations:
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: