Trial to Collect Safety Data and Sera for Immunogenicity Testing

NCT ID: NCT00389857

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-07-31

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).

Conditions

Influenza

Study Design

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

Study Groups

Influenza vaccine-naive group

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.

Group Type: EXPERIMENTAL

Influenza Virus Vaccine (Fluzone®)

Intervention Type: BIOLOGICAL

0.25 mL, Intramuscular (infant/children dose)

Influenza vaccine-primed group

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

Group Type: EXPERIMENTAL

Influenza Virus Vaccine (Fluzone®)

Intervention Type: BIOLOGICAL

0.25 mL, Intramuscular (infant/children dose)

Interventions

Influenza Virus Vaccine (Fluzone®)

0.25 mL, Intramuscular (infant/children dose)

Intervention Type: BIOLOGICAL

Influenza Virus Vaccine (Fluzone®)

0.25 mL, Intramuscular (infant/children dose)

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 (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.

• 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

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

GRC34

Identifier Type: -

Identifier Source: org_study_id