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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00836953
First received: February 3, 2009
Last updated: January 16, 2014
Last verified: January 2014

February 3, 2009
January 16, 2014
September 2003
January 2004   (final data collection date for primary outcome measure)
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination [ Time Frame: Day 0 to 3 post-vaccination ] [ Designated as safety issue: Yes ]
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.
  • To provide information concerning the immunogenicity of Fluzone®. [ Time Frame: 44 days post-vaccination ] [ Designated as safety issue: No ]
  • To provide information concerning the safety after administration of Fluzone®. [ Time Frame: 0 to 4 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00836953 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection) [ Time Frame: Day 0 and Day 14 after Dose 2 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Seroconversion defined as the percentage of participants with ≥ 4-fold increases in reciprocal hemagglutination inhibition titer from pre- to post-vaccination.
Not Provided
 
Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®
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

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

The study is to collect sera from healthy children being administered the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Influenza
Biological: Influenza virus vaccine (Pediatric formulation)
0.25 mL, Intramuscular
Other Name: Fluzone®
Experimental: Study Group
Participants received 2 doses of Fluzone® vaccine
Intervention: Biological: Influenza virus vaccine (Pediatric formulation)
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.
 
Completed
33
July 2004
January 2004   (final data collection date for primary outcome measure)

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.
Both
6 Months to 36 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00836953
GRC17
No
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc.
Sanofi
January 2014

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