Trial to Collect Safety Data and Sera for Immunogenicity Testing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00389857
First received: October 18, 2006
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

To provide Centers for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2006-2007 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC) and World Health Organization (WHO).


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 (2006-2007 Formulation)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination [ Time Frame: 14 days 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 2006-2007 Pediatric formulation.

    Post-dose 1 (Influenza vaccine-primed group); Post-dose 2 (Influenza vaccine-naive group)



Other Outcome Measures:
  • Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. [ Time Frame: 0 to 3 days post-vaccination 1 ] [ Designated as safety issue: Yes ]
    Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia).

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

    Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia).

    Note: Influenza vaccine-primed group did not receive vaccination 2



Enrollment: 31
Study Start Date: October 2006
Study Completion Date: July 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Influenza vaccine-naive group
Participants have never received Influenza virus vaccine in the past. They will receive a single dose of Fluzone vaccine on Day 0 and Day 28, respectively.
Biological: Influenza Virus Vaccine (Fluzone®)
0.25 mL, Intramuscular (infant/children dose)
Other Name: Fluzone®
Experimental: Influenza vaccine-primed group
Participants have received Influenza virus vaccine in the past. They will receive a single dose of Fluzone vaccine on Day 0.
Biological: Influenza Virus Vaccine (Fluzone®)
0.25 mL, Intramuscular (infant/children dose)
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 (5.5 lbs).

Exclusion Criteria:

  • Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
  • An acute illness with or without fever (For infants/toddlers: temperature

    ≥ 100.4 °F rectal; For children: temperature ≥ 99.5 °F oral/axillary) 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 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.
  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: NCT00389857

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: NCT00389857     History of Changes
Other Study ID Numbers: GRC34
Study First Received: October 18, 2006
Results First Received: February 24, 2009
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Influenza
Influenza Virus Vaccine
Fluzone®

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 July 24, 2014