Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®

Sanofi

Status and phase

Completed

Phase 4

Conditions

Influenza

Treatments

Biological: Influenza virus vaccine (Pediatric formulation)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00836953

GRC17

Details and patient eligibility

About

To describe the safety findings from Days 0 to 44 following injection of the 2003-2004 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 findings from Days 0 to 44 following injection of the 2003-2004 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

Full description

The study is to collect sera from healthy children being administered the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®.

Enrollment

33 patients

Sex

All

Ages

6 to 36 months old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

Aged ≥ 6 months to < 36 months.
Considered to be in good health on the basis of reported medical history and limited physical examination.
Available for the duration of the study (44 days +4 days).
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.