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Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®

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ClinicalTrials.gov Identifier: NCT00836953
Recruitment Status : Completed
First Posted : February 4, 2009
Results First Posted : August 27, 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 February 3, 2009
First Posted Date  ICMJE February 4, 2009
Results First Submitted Date  ICMJE July 20, 2009
Results First Posted Date  ICMJE August 27, 2009
Last Update Posted Date April 14, 2016
Study Start Date  ICMJE September 2003
Actual Primary Completion Date January 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2014)
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination [ Time Frame: Day 0 to 3 post-vaccination ]
Solicited local reactions: Erythema (redness), induration, bruising and pain at the injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting and rash.
Original Primary Outcome Measures  ICMJE
 (submitted: February 3, 2009)
  • To provide information concerning the immunogenicity of Fluzone®. [ Time Frame: 44 days post-vaccination ]
  • To provide information concerning the safety after administration of Fluzone®. [ Time Frame: 0 to 4 days post-vaccination and entire study duration ]
Change History Complete list of historical versions of study NCT00836953 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: January 16, 2014)
  • Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection) [ Time Frame: Day 0 and Day 14 after Dose 2 ]
    Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers ≥40 pre- and post-vaccination.
  • Percentage of Participants With at Least a 4-fold Rise in Reciprocal Hemagglutination Inhibition Titers (Seroconversion) [ Time Frame: Day 0 and Day 14 Post-dose 2 ]
    Seroconversion defined as the percentage of participants with ≥ 4-fold increases in reciprocal hemagglutination inhibition titer from pre- to post-vaccination.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®
Official Title  ICMJE A Trial for the Collection of Sera in Healthy Children Receiving Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® 2003/2004
Brief Summary

To describe the safety findings from Days 0 to 44 following injection of the 2003-2004 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 findings from Days 0 to 44 following injection of the 2003-2004 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

Detailed Description The study is to collect sera from healthy children being administered the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE Biological: Influenza virus vaccine (Pediatric formulation)
0.25 mL, Intramuscular
Other Name: Fluzone®
Study Arms  ICMJE Experimental: Study Group
Participants received 2 doses of Fluzone® vaccine
Intervention: Biological: Influenza virus vaccine (Pediatric formulation)
Publications * Mitchell DK, Ruben FL, Gravenstein S. Immunogenicity and safety of inactivated influenza virus vaccine in young children in 2003-2004. Pediatr Infect Dis J. 2005 Oct;24(10):925-7.

*   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: February 3, 2009)
33
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2004
Actual Primary Completion Date January 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria :

  • Aged ≥ 6 months to < 36 months.
  • Considered to be in good health on the basis of reported medical history and limited physical examination.
  • Available for the duration of the study (44 days +4 days).
  • 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 human immunodeficiency virus (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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 36 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 NCT00836953
Other Study ID Numbers  ICMJE GRC17
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