Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine

NCT ID: NCT00258817

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2007-08-31

Brief Summary

To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO) for characterization of circulating influenza strains.

Observational Objectives:

To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine, 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 2005-2006 pediatric formulation of Fluzone vaccine, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months.

Conditions

Influenza

Study Design

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

Study Groups

Influenza Virus Vaccine Naïve

Subjects have never received Influenza virus vaccine in the past

Group Type: EXPERIMENTAL

Influenza Virus Vaccine (Fluzone®)

Intervention Type: BIOLOGICAL

0.25 mL, Intramuscular (Day 0 and Day 28)

Influenza Virus Vaccine-primed

Subjects have received Influenza virus vaccine in the past

Group Type: EXPERIMENTAL

Influenza Virus Vaccine (Fluzone®)

Intervention Type: BIOLOGICAL

0.25 mL, Intramuscular (Day 0)

Interventions

Influenza Virus Vaccine (Fluzone®)

0.25 mL, Intramuscular (Day 0 and Day 28)

Intervention Type: BIOLOGICAL

Influenza Virus Vaccine (Fluzone®)

0.25 mL, Intramuscular (Day 0)

Intervention Type: BIOLOGICAL

Other Intervention Names

Fluzone®; Fluzone®

Eligibility 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.

Exclusion Criteria

• Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
• 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 (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 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 36 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

Clinical Trials

Role: STUDY_DIRECTOR

Sanofi Pasteur, a Sanofi Company

Locations

Norfolk, Virginia, United States

Countries

United States

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

GRC26

Identifier Type: -

Identifier Source: org_study_id