Study of Safety and Immunogenicity of Fluzone® in Healthy Children

NCT ID: NCT00831675

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2006-04-30

Brief Summary

To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months.

To describe the immunogenicity of the 2004-2005 inactivated, split-virion influenza vaccine Fluzone®, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months

Detailed Description

To provide the Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO).

Conditions

Influenza

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Infants <12 Months

Participants aged ≥ 6 to \< 12 months at enrollment and received 2 doses of Fluzone® Vaccine

Group Type: EXPERIMENTAL

Influenza Vaccine 2004-2005 Paediatric Formulation

Intervention Type: BIOLOGICAL

0.25 mL (Day 0 and Day 28), Intramuscular

Toddlers ≥12 Months

Participants aged ≥ 12 to \< 36 months at enrollment and received 2 doses of Fluzone® vaccine

Group Type: EXPERIMENTAL

Influenza Vaccine 2004-2005 Paediatric Formulation

Intervention Type: BIOLOGICAL

0.25 mL (Day 0 and Day 28), Intramuscular

Interventions

Influenza Vaccine 2004-2005 Paediatric Formulation

0.25 mL (Day 0 and Day 28), Intramuscular

Intervention Type: BIOLOGICAL

Influenza Vaccine 2004-2005 Paediatric Formulation

0.25 mL (Day 0 and Day 28), Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

Fluzone®; Fluzone®

Eligibility Criteria

Inclusion Criteria

• Participant is aged ≥ 6 months to < 36 months.
• 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/guardian is willing and able to provide informed consent.
• Parent/guardian is willing and able to meet protocol requirements.

Exclusion Criteria

• Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
• Previous history of influenza vaccination or documented history of influenza infection.
• An acute illness with or without fever (temperature > 100.4 °F rectal) in the 72 hours preceding enrollment in the trial (defer enrollment).
• Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude).
• Participation in any other 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 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.
• Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 35 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

Norfolk, Virginia, United States

Countries

United States

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

GRC21

Identifier Type: -

Identifier Source: org_study_id