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Trial to Collect Safety Data and Sera for Immunogenicity Testing
This study has been completed.
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
Drug Information available for: 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 Fluzone (2006-2007 formulation) [ Time Frame: 14 days post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To provide information concerning the safety of Fluzone (2006-2007 formulation) [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: October 2006
Study Completion Date: July 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Biological: Influenza Virus Vaccine
0.25 mL, Intramuscular (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: Medical Director Sanofi Pasteur Inc.
  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
Study First Received: October 18, 2006
Last Updated: September 24, 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 January 16, 2009