Expired Study
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Norfolk, Virginia


To provide Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2007-2008 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.


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 (5.5 lbs). Exclusion Criteria: - Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine. - An acute illness with or without fever (For infants/toddlers: temperature ≥ 100.4°F rectal; For children: temperature ≥ 99.5°F oral/axillary) 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 or planned 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 personal 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. - Received any vaccinations within the preceding 14 days (enrollment may be deferred).



Primary Contact:

Study Director
Medical Director
Sanofi Pasteur Inc.

Backup Contact:


Location Contact:

Norfolk, Virginia
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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