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Study of Safety and Immunogenicity of Fluzone® in Healthy Children
This study has been completed.
First Received: January 28, 2009   No Changes Posted
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00831675
  Purpose

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


Condition Intervention Phase
Influenza
Biological: Influenza Vaccine 2004-2005 Paediatric Formulation
Phase IV

MedlinePlus related topics: Flu
Drug Information available for: Fluvirin Influenza Vaccines
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Influenza Virus Vaccine Fluzone® 2004-2005

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Immunogenicity: To provide information concerning the immunogenicity (or immune response) of Fluzone after primary vaccination. [ Time Frame: 14 days post vaccination ] [ Designated as safety issue: No ]
  • Safety: To provide information concerning the safety after primary administration of Fluzone [ Time Frame: 4 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: September 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Influenza Vaccine: Experimental
Fluzone® Vaccine Group
Biological: Influenza Vaccine 2004-2005 Paediatric Formulation
0.25 mL (Day 0 and Day 28), Intramuscular

Detailed Description:

To provide CBER with sera collected from healthy children receiving the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by FDA, CDC and WHO.

  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831675

Locations
United States, Virginia
Norfolk, Virginia, United States, 23510
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi Pasteur Inc. ( Medical Monitor )
Study ID Numbers: GRC21
Study First Received: January 28, 2009
Last Updated: January 28, 2009
ClinicalTrials.gov Identifier: NCT00831675     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:
Influenza

Study placed in the following topic categories:
Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Healthy
Orthomyxoviridae Infections

Additional relevant MeSH terms:
Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on May 06, 2009