Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine

Sanofi

Status and phase

Completed

Phase 4

Conditions

Influenza

Treatments

Biological: 2007-2008 Influenza Virus Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00561002

GRC38

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

6 to 35 months old

Volunteers

Accepts Healthy Volunteers

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).