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Single-Center, Open Label, Single-Arm Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing

This study is ongoing, but not recruiting participants.

Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00389857
  Purpose

To provide CBER with sera collected from healthy children receiving the 2006-2007 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by FDA, CDC and WHO.


Condition Intervention Phase
Influenza Vaccines
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:

Estimated Enrollment:   30
Study Start Date:   October 2006

Intervention Details:
    Biological: Influenza Virus Vaccine
    Vaccine (infant /children dose)
  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 (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; 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 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389857

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 Monitor )
Study ID Numbers:   GRC34
First Received:   October 18, 2006
Last Updated:   January 3, 2008
ClinicalTrials.gov Identifier:   NCT00389857
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
Orthomyxoviridae Infections

Additional relevant MeSH terms:
RNA Virus Infections

ClinicalTrials.gov processed this record on September 19, 2008




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