Expired Study
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Norfolk, Virginia 23510


Purpose:

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


Study summary:

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).


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.


NCT ID:

NCT00831675


Primary Contact:

Study Director
Medical Director
Sanofi Pasteur Inc.


Backup Contact:

N/A


Location Contact:

Norfolk, Virginia 23510
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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