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Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 Months of Age

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ClinicalTrials.gov Identifier: NCT00858468
Recruitment Status : Completed
First Posted : March 9, 2009
Results First Posted : July 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 March 5, 2009
First Posted Date  ICMJE March 9, 2009
Results First Submitted Date  ICMJE April 20, 2009
Results First Posted Date  ICMJE July 31, 2009
Last Update Posted Date April 14, 2016
Study Start Date  ICMJE April 2005
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2014)
Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. [ Time Frame: Day 0 to Day 7 post-vaccination ]
Solicited local (injection site) reactions: Tenderness, erythema (redness), and swelling Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Loss of Appetite, and Irritability.
Original Primary Outcome Measures  ICMJE
 (submitted: March 5, 2009)
  • To provide information concerning the immunogenicity of Fluzone among the investigational and control groups. [ Time Frame: Day 56 (21 to 35 days post-vaccination 2) ]
  • To provide information concerning the safety of Fluzone vaccination. [ Time Frame: 7days post-vaccination and entire study duration ]
Change History Complete list of historical versions of study NCT00858468 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 Serum Hemagglutination Inhibition Antibody Titer ≥ 40 Post-vaccination With Fluzone® (Seroprotection). [ Time Frame: 21 days post-vaccination 2 ]
    Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation. Seroprotection was defined as the percentage of participants with a reciprocal hemagglutination inhibition titers ≥ 40
  • Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion). [ Time Frame: 21 days post-vaccination 2 ]
    Seroconversion was defined as the percentage of participants with a pre-titer < 1:10 who demonstrated a ≥ 4-fold increases in titer from pre- to post-vaccination.
  • Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine. [ Time Frame: 21 days post-vaccination 2 ]
    Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 Months of Age
Official Title  ICMJE Proof of Concept Study of the Safety and Immunogenicity of Influenza Virus Vaccine Fluzone® 2004-2005 Among Healthy Children 2 Months vs 6 Months of Age
Brief Summary

Primary Objective:

To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the package insert for vaccine-naïve young children) to the investigational and control groups.

Observational Objective:

To describe the percentage of protective Hemagglutination Inhibition (HAI) antibody titers (following a 2-dose Fluzone® immunization series) to each of the 3 vaccine antigens among the investigational and control groups.

Detailed Description This is an observational and descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children aged 6 to 12 weeks (the investigational group, also referred to as the 2-month-old group) versus children aged 24 to 36 weeks (the control group, also referred to as the 6-month-old group). The study is not designed to achieve any preset statistical power, and no hypotheses will be tested.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE Biological: Influenza virus vaccine (2004-2005 Formulation)
0.25 mL, Intramuscular
Other Name: Fluzone® Preservative-free
Study Arms  ICMJE
  • Experimental: Group 1
    Participants aged 6 to 12 Weeks at enrollment
    Intervention: Biological: Influenza virus vaccine (2004-2005 Formulation)
  • Experimental: Group 2
    Participants aged 24 to 36 Weeks at enrollment
    Intervention: Biological: Influenza virus vaccine (2004-2005 Formulation)
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: March 5, 2009)
394
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria :

  • Aged 42 to 84 days (6 to 12 weeks) or 24 to 36 weeks on the day of inclusion.
  • Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg.
  • Considered to be in good health on the basis of reported medical history and history-directed physical examination.
  • Available for the duration of the study.
  • Parent/guardian willing and able to provide informed consent.
  • Parent/guardian able to attend all scheduled visits and comply with all trial procedures.
  • Willingness to permit venipuncture or heel stick for purposes of collecting a blood sample.

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.
  • Receipt of any vaccine in the 7 days prior to enrollment.
  • An acute illness with fever (rectal temperature ≥ 38.0 °C [or ≥ 100.4 °F]) in the 72 hours preceding enrollment in the trial (defer enrollment).
  • Known bleeding disorder.
  • Participation in any other clinical trial within 30 days prior to enrollment, or planned participation in another clinical trial prior to termination of the subject's participation in this 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 could interfere with trial conduct or completion.
  • Known HIV-positive or HBsAg-positive mother.
  • Known HIV, hepatitis B (HBsAg), or hepatitis C infection.
  • Blood or blood-derived products received in the past 2 months.
  • 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 2 Months to 9 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 NCT00858468
Other Study ID Numbers  ICMJE GRC27
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