Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00755274
First received: September 16, 2008
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

Primary Objective:

To provide the Center for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2008-2009 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.

Observational Objectives:

To describe the safety of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children ≥ 6 months to < 5 years of age.

To describe the immunogenicity of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with ACIP recommendations, in children ≥ 6 months to < 5 years of age.


Condition Intervention Phase
Influenza
Orthomyxoviridae Infections
Biological: Influenza Virus Vaccine No Preservative: Pediatric Dose
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 Fluzone® Influenza Virus Vaccine (2008-2009 Formulation)

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 Fluzone® Vaccination 1 [ Time Frame: Day 0 to Day 3 post-vaccination 1 ] [ Designated as safety issue: Yes ]
    Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.

  • Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 [ Time Frame: Day 0 to Day 3 post-vaccination 2 ] [ Designated as safety issue: Yes ]
    Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.


Other Outcome Measures:
  • Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination [ Time Frame: Day 28 post-single dose or Day 21 post-Dose 2 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) [ Time Frame: Day 28 post-single dose or Day 21 post-Dose 2 ] [ Designated as safety issue: No ]
    Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for all participants and those enrolled at age 6 to 35 months.

  • Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) [ Time Frame: Day 28 post-single dose or Day 21 post-Dose 2 ] [ Designated as safety issue: No ]
    Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for participants enrolled at age 36 to 59 months.

  • Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) [ Time Frame: Day 28 post-single dose or Day 21 post-Dose 2 ] [ Designated as safety issue: No ]
    Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for all participants and those enrolled at age 6 to 35 months of age.

  • Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) [ Time Frame: Day 28 post-single dose or Day 21 post-Dose 2 ] [ Designated as safety issue: No ]
    Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for participants enrolled at age 36 to 59 months.


Enrollment: 32
Study Start Date: September 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: Primed
Have received 2 or more lifetime Flu Vaccinations Prior to Visit 1
Biological: Influenza Virus Vaccine No Preservative: Pediatric Dose
0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)
Other Name: Fluzone®
Experimental: Group 2: Naive/Inadequately Primed
Never Received or Received Only 1 Lifetime Flu Vaccination Prior to Visit 1
Biological: Influenza Virus Vaccine No Preservative: Pediatric Dose
0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)
Other Name: Fluzone®

Detailed Description:

The Advisory Committee on Immunization Practices (ACIP) has in recent years recommended that all healthy children aged 6 through 59 months receive influenza vaccine. Because of the growing emphasis on influenza immunization of infants and young children, Center for Biologics Evaluation and Research (CBER) has expressed interest in receiving sera from children who have been vaccinated with the current formulation of Fluzone® vaccine. These sera will be tested to evaluate each individual's immune response to the current formulation of Fluzone® vaccine and will also be used to evaluate circulating influenza strains in order to support formulation recommendations for the subsequent year (particularly for influenza B strains, which predominantly affect the young).

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant is ≥ 6 months to < 5 years of age.
  • Participant is considered to be in good health on the basis of reported medical history and a limited history-directed physical examination.
  • Parent/legal acceptable representative is willing and able to bring the subject to the scheduled visits and to comply with the study procedures during the entire duration of the study.
  • Parent/legal acceptable representative is willing and able to provide informed consent.
  • Subject was born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs).

Exclusion Criteria:

  • Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
  • History of severe adverse event to any influenza vaccine.
  • Laboratory-confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment in the study.
  • Any vaccination scheduled between Visit 1 and Visit 2.
  • Planned participation in any other interventional clinical trial during 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 personal 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.
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00755274

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: NCT00755274     History of Changes
Other Study ID Numbers: GRC40
Study First Received: September 16, 2008
Results First Received: February 1, 2010
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Influenza
Orthomyxoviruses
Orthomyxoviridae Infections
Influenza vaccine

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 15, 2014