Trial to Collect Safety Data and Sera for Immunogenicity Testing

Sanofi

Status and phase: Completed; Phase 4

Conditions: Influenza

Treatments: Biological: Influenza Virus Vaccine (Fluzone®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00389857

GRC34

Details and patient eligibility

About

To provide Centers for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2006-2007 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC) and World Health Organization (WHO).

Enrollment: 31 patients

Sex: All

Ages: 6 to 36 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 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 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Influenza vaccine-naive group

Experimental group

Description:

Participants have never received Influenza virus vaccine in the past. They will receive a single dose of Fluzone vaccine on Day 0 and Day 28, respectively.

Treatment:

Biological: Influenza Virus Vaccine (Fluzone®)

Biological: Influenza Virus Vaccine (Fluzone®)

Influenza vaccine-primed group

Experimental group

Description:

Participants have received Influenza virus vaccine in the past. They will receive a single dose of Fluzone vaccine on Day 0.

Treatment:

Biological: Influenza Virus Vaccine (Fluzone®)

Biological: Influenza Virus Vaccine (Fluzone®)