Trial to Collect Safety Data and Sera for Immunogenicity Testing

Phase 4

Completed

• Conditions: Influenza
• Interventions: Biological: Influenza Virus Vaccine (Fluzone®)

• Registration Number: NCT00389857
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-18
• Study First Submitted QC: 2006-10-18
• Study First Posted: 2006-10-19
• Primary Completion: 2007-09
• Study Completion: 2008-07
• Results First Submitted: 2009-02-24
• Results First Submitted QC: 2009-03-23
• Results First Posted: 2009-03-24
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Influenza vaccine-primed group	Influenza Virus Vaccine (Fluzone®)	Participants have received Influenza virus vaccine in the past. They will receive a single dose of Fluzone vaccine on Day 0.
Influenza vaccine-naive group	Influenza Virus Vaccine (Fluzone®)	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.

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination	14 days post-vaccination	GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone vaccine 2006-2007 Pediatric formulation.; Post-dose 1 (Influenza vaccine-primed group); Post-dose 2 (Influenza vaccine-naive group)