Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®

NCT ID: NCT00755274

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-01-31

Brief Summary

Primary Objective:

To provide the Center for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2008-2009 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.

Observational Objectives:

To describe the safety of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children ≥ 6 months to < 5 years of age.

To describe the immunogenicity of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with ACIP recommendations, in children ≥ 6 months to < 5 years of age.

Detailed Description

The Advisory Committee on Immunization Practices (ACIP) has in recent years recommended that all healthy children aged 6 through 59 months receive influenza vaccine. Because of the growing emphasis on influenza immunization of infants and young children, Center for Biologics Evaluation and Research (CBER) has expressed interest in receiving sera from children who have been vaccinated with the current formulation of Fluzone® vaccine. These sera will be tested to evaluate each individual's immune response to the current formulation of Fluzone® vaccine and will also be used to evaluate circulating influenza strains in order to support formulation recommendations for the subsequent year (particularly for influenza B strains, which predominantly affect the young).

Conditions

Influenza; Orthomyxoviridae Infections

Study Design

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

Study Groups

Group 1: Primed

Have received 2 or more lifetime Flu Vaccinations Prior to Visit 1

Group Type: EXPERIMENTAL

Influenza Virus Vaccine No Preservative: Pediatric Dose

Intervention Type: BIOLOGICAL

0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)

Group 2: Naive/Inadequately Primed

Never Received or Received Only 1 Lifetime Flu Vaccination Prior to Visit 1

Group Type: EXPERIMENTAL

Influenza Virus Vaccine No Preservative: Pediatric Dose

Intervention Type: BIOLOGICAL

0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)

Interventions

Influenza Virus Vaccine No Preservative: Pediatric Dose

0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)

Intervention Type: BIOLOGICAL

Influenza Virus Vaccine No Preservative: Pediatric Dose

0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)

Intervention Type: BIOLOGICAL

Other Intervention Names

Fluzone®; Fluzone®

Eligibility Criteria

Inclusion Criteria

• Participant is ≥ 6 months to < 5 years of age.
• Participant is considered to be in good health on the basis of reported medical history and a limited history-directed physical examination.
• Parent/legal acceptable representative is willing and able to bring the subject to the scheduled visits and to comply with the study procedures during the entire duration of the study.
• Parent/legal acceptable representative is willing and able to provide informed consent.
• Subject was 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.
• History of severe adverse event to any influenza vaccine.
• Laboratory-confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment in the study.
• Any vaccination scheduled between Visit 1 and Visit 2.
• Planned participation in any other interventional clinical trial during 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.
• Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 5 Years
• 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

GRC40

Identifier Type: -

Identifier Source: org_study_id