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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: 2007-2008 Influenza Virus Vaccine (Biological); 2007-2008 Influenza Virus Vaccine (Biological)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi Pasteur, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Sanofi Pasteur Inc.

Summary

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.

Clinical Details

Official title: Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone Influenza Virus Vaccine (2007-2008 Formulation)

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation

Eligibility

Minimum age: 6 Months. Maximum age: 35 Months. Gender(s): Both.

Criteria:

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).

Locations and Contacts

Norfolk, Virginia, United States
Additional Information

Starting date: October 2007
Last updated: January 17, 2014

Page last updated: August 20, 2015

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