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

This study has been completed.

Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00258817
  Purpose

To provide serum to FDA for use by FDA, CDC, and WHO for characterization of circulating influenza strains.

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.


Condition Intervention Phase
Influenza
Biological: Influenza Virus Vaccine
Phase IV

MedlinePlus related topics:   Flu   

ChemIDplus related topics:   Influenza Vaccines    Fluvirin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • To provide information concerning the immunogenicity of the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone. [ Time Frame: 42 Days post-vaccination ] [ Designated as safety issue: No ]

Enrollment:   30
Study Start Date:   October 2005
Study Completion Date:   August 2007
Primary Completion Date:   March 2006 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental Biological: Influenza Virus Vaccine
0.25 mL, Intramuscular

  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 (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; see Section 5.3.5 of the protocol).
  • 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 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258817

Locations
United States, Virginia
      Norfolk, Virginia, United States, 23510

Sponsors and Collaborators
Sanofi-Aventis

Investigators
Study Director:     Clinical Trials     sanofi pasteur    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 
Related Info  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Sanofi Pasteur Inc. ( Medical Director )
Study ID Numbers:   GRC26
First Received:   November 24, 2005
Last Updated:   September 19, 2008
ClinicalTrials.gov Identifier:   NCT00258817
Health Authority:   United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:
Influenza Vaccine  

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

Additional relevant MeSH terms:
RNA Virus Infections

ClinicalTrials.gov processed this record on October 06, 2008




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