Study of Safety and Immunogenicity of Fluzone® in Healthy Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00831675
First received: January 28, 2009
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

To describe the safety of the 2004-2005 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 of the 2004-2005 inactivated, split-virion influenza vaccine Fluzone®, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months


Condition Intervention Phase
Influenza
Biological: Influenza Vaccine 2004-2005 Paediatric Formulation
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Influenza Virus Vaccine Fluzone® 2004-2005

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation [ Time Frame: Days 0-3 Post-dose ] [ Designated as safety issue: Yes ]

    Solicited local reactions: Erythema, bruising, induration, pain at injection site.

    Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting, rash collected daily for four days after each injection.



Other Outcome Measures:
  • Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation [ Time Frame: 14 days post-vaccination ] [ Designated as safety issue: No ]
  • Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection) [ Time Frame: 14 days post-vaccination ] [ Designated as safety issue: No ]
    Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers ≥40 post-vaccination with Fluzone®.

  • Percentage of Participants With a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroconversion) [ Time Frame: Day 14 post-vaccination ] [ Designated as safety issue: Yes ]
    Seroconversion defined as the percentage of participants with a ≥ 4-fold increases in titer from pre- to post-vaccination with Fluzone®.


Enrollment: 30
Study Start Date: September 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infants <12 Months
Participants aged ≥ 6 to < 12 months at enrollment and received 2 doses of Fluzone® Vaccine
Biological: Influenza Vaccine 2004-2005 Paediatric Formulation
0.25 mL (Day 0 and Day 28), Intramuscular
Other Name: Fluzone®
Experimental: Toddlers ≥12 Months
Participants aged ≥ 12 to < 36 months at enrollment and received 2 doses of Fluzone® vaccine
Biological: Influenza Vaccine 2004-2005 Paediatric Formulation
0.25 mL (Day 0 and Day 28), Intramuscular
Other Name: Fluzone®

Detailed Description:

To provide the Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO).

  Eligibility

Ages Eligible for Study:   6 Months to 35 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Participant is aged ≥ 6 months to < 36 months.
  • Participant is considered to be in good health on the basis of reported medical history and limited physical examination.
  • Participant is available for the duration of the study.
  • 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.
  • Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831675

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:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00831675     History of Changes
Other Study ID Numbers: GRC21
Study First Received: January 28, 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® vaccine
Infants
Toddlers

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 September 30, 2014