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
  Purpose

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


Condition Intervention Phase
Influenza
Biological: Influenza virus vaccine (Pediatric formulation)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 33
Study Start Date: September 2003
Study Completion Date: July 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Group
Participants received 2 doses of Fluzone® vaccine
Biological: Influenza virus vaccine (Pediatric formulation)
0.25 mL, Intramuscular
Other Name: Fluzone®

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®.

  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836953

Locations
United States, Virginia
Norfolk, Virginia, United States, 23510
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00836953     History of Changes
Other Study ID Numbers: GRC17
Study First Received: February 3, 2009
Results First Received: July 20, 2009
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Influenza
Fluzone®
Children

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 22, 2014