Clinical trial NCT00258817: Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine
Official title: Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2005-2006 Formulation)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Fluzone®
Influenza Virus Vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-11-28
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO) for characterization of circulating influenza strains.

Observational Objectives:

To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine, 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 2005-2006 pediatric formulation of Fluzone vaccine, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months.


Eligibility criteria: Inclusion Criteria:

* Participant is aged ≥ 6 months (24 weeks) to \< 36 months (3rd birthday).
* 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/legal acceptable representative is willing and able to provide informed consent.
* Parent/legal acceptable representative is willing and able to meet protocol requirements.
* Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg.

Exclusion Criteria:

* Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
* 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 (Enrollment may be deferred).
* Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude).
* Participation in any other interventional 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.

Primary outcomes:
measure: Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination
timeFrame: Day 14 post-vaccination
Secondary outcomes:
Other outcomes:
measure: Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1
timeFrame: 0 to 3 days post-vaccination 1
measure: Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2
timeFrame: 0 to 3 days post-vaccination 2
Locations:
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Clinical Trials
role: STUDY_DIRECTOR
References: