Study of Safety and Immunogenicity of Fluzone® in Healthy Children

Sanofi

Status and phase

Completed

Phase 4

Conditions

Influenza

Treatments

Biological: Influenza Vaccine 2004-2005 Paediatric Formulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT00831675

GRC21

Details and patient eligibility

About

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

Full 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).

Enrollment

30 patients

Sex

All

Ages

6 to 35 months old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.