Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00258817
First received: November 24, 2005
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO) for characterization of circulating influenza strains.

Observational Objectives:

To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine, 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 2005-2006 pediatric formulation of Fluzone vaccine, 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 Virus Vaccine (Fluzone®)
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 (2005-2006 Formulation)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination [ Time Frame: Day 14 post-vaccination ] [ Designated as safety issue: No ]

    GMTs and their 95% Confidence interval are presented for each of the 3 antigens in the Fluzone® vaccine 2005-2006 Pediatric formulation.

    Post-dose 1 (Influenza vaccine Primed group); post-dose 2 (Influenza vaccine Naive group)



Other Outcome Measures:
  • Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 [ Time Frame: 0 to 3 days post-vaccination 1 ] [ Designated as safety issue: Yes ]
    Solicited local reactions: injection site erythema, injection site swelling, injection site tenderness; Solicited systemic reactions: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, and vomiting.

  • Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 [ Time Frame: 0 to 3 days post-vaccination 2 ] [ Designated as safety issue: Yes ]

    Solicited local reactions: injection site erythema, injection site swelling, injection site tenderness; Solicited systemic reactions: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, and vomiting

    Note: Influenza vaccine-primed group received only dose 1



Enrollment: 30
Study Start Date: October 2005
Study Completion Date: August 2007
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Influenza Virus Vaccine Naïve
Subjects have never received Influenza virus vaccine in the past
Biological: Influenza Virus Vaccine (Fluzone®)
0.25 mL, Intramuscular (Day 0 and Day 28)
Other Name: Fluzone®
Experimental: Influenza Virus Vaccine-primed
Subjects have received Influenza virus vaccine in the past
Biological: Influenza Virus Vaccine (Fluzone®)
0.25 mL, Intramuscular (Day 0)
Other Name: Fluzone®

  Eligibility

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

Inclusion Criteria:

  • Participant is aged ≥ 6 months (24 weeks) to < 36 months (3rd birthday).
  • 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/legal acceptable representative is willing and able to provide informed consent.
  • Parent/legal acceptable representative is willing and able to meet protocol requirements.
  • Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg.

Exclusion Criteria:

  • Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
  • 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 (Enrollment may be deferred).
  • Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude).
  • Participation in any other interventional 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
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: NCT00258817

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

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00258817     History of Changes
Other Study ID Numbers: GRC26
Study First Received: November 24, 2005
Results First Received: January 21, 2009
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Fluzone®
Influenza Virus 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 August 28, 2014