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Safety and Immunogenicity of Fluzone® Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation.

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ClinicalTrials.gov Identifier: NCT00390884
Recruitment Status : Completed
First Posted : October 23, 2006
Results First Posted : December 31, 2009
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE October 20, 2006
First Posted Date  ICMJE October 23, 2006
Results First Submitted Date  ICMJE September 21, 2009
Results First Posted Date  ICMJE December 31, 2009
Last Update Posted Date April 14, 2016
Study Start Date  ICMJE October 2006
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2014)
Percentage of Seroprotected Participants Post-vaccination With Fluzone® [ Time Frame: Day 28 Post-vaccination ]
Seroprotection was defined as a Post-vaccination Hemagglutination Inhibition titer of greater than or equal to 1:40.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00390884 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2014)
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone® [ Time Frame: Day 28 Post-vaccination ]
Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: January 16, 2014)
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® [ Time Frame: Days 0-7 Post-vaccination ]
Solicited injection site: tenderness, erythema, and swelling; Solicited systemic reactions: fever, vomiting, abnormal crying, drowsiness, appetite loss, and irritability, after each vaccination
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity of Fluzone® Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation.
Official Title  ICMJE Safety and Immunogenicity of Fluzone® Influenza Virus Vaccine (2006-2007 Formulation) Among Healthy Children Immunized in Fall 2005 With Fluzone Vaccine or Placebo
Brief Summary To compare the groups with respect to influenza immune responses following Dose 1 of Fluzone vaccine (2006-2007 formulation).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE Biological: Influenza Virus Vaccine, Fluzone®
0.25 mL, Intramuscular
Other Name: Fluzone®
Study Arms  ICMJE
  • Experimental: Fluzone®-Primed Group
    Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28, NCT00242424), will receive 2 doses of Fluzone® Pediatric 2006-2007 formulation.
    Intervention: Biological: Influenza Virus Vaccine, Fluzone®
  • Experimental: Fluzone®-Naive Group
    Participants had never received Influenza vaccine and had received two doses of placebo in the fall of 2005 (Study GRC28, NCT00242424), will receive 2 doses of Fluzone® Pediatric 2006-2007 formulation.
    Intervention: Biological: Influenza Virus Vaccine, Fluzone®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2009)
173
Original Enrollment  ICMJE
 (submitted: October 20, 2006)
524
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria :

  • Previously enrolled in study GRC28 and received 2 vaccinations of the assigned lot.
  • Considered to be in good health on the basis of reported medical history and history-directed physical evaluation.
  • Available for the duration of the study.
  • Parent/legal representative willing and able to provide informed consent.
  • Parent/legal representative able to attend all scheduled visits and comply with all trial procedures.
  • Parent/legal representative willing to permit venipuncture for purposes of collecting a blood sample.

Exclusion Criteria :

  • Receipt of any vaccine within the past 7 days (subjects may be deferred until after the seven days has passed.)
  • Reported allergy to egg proteins, chicken proteins or any other constituent of the vaccine.
  • Ever received any influenza vaccine, other than at Visits 1 and 2 of study GRC28, or known to have ever been diagnosed with laboratory-confirmed influenza.
  • An acute illness with fever (rectal temperature ≥ 100.4°F [38.0°C]) in the 72 hours preceding enrollment in the trial (defer enrollment).
  • Known bleeding disorder.
  • Participation in any other interventional clinical trial within 30 days prior to enrollment, or planned participation in another interventional clinical trial prior 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 that, in the opinion of the investigator, could interfere with trial conduct or completion.
  • Known Human Immunodeficiency Virus (HIV)-positive mother or Hepatitis B surface antigen (HBsAg)-positive mother.
  • Known HIV, Hepatitis B, or Hepatitis C infection.
  • Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
  • Prior personal history of Guillain-Barré syndrome.
  • Any condition that, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Months to 14 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00390884
Other Study ID Numbers  ICMJE GRC29
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director sanofi pasteur Inc
PRS Account Sanofi
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP