Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing 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:
NCT00561002
First received: November 19, 2007
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

To provide Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2007-2008 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.


Condition Intervention Phase
Influenza
Biological: 2007-2008 Influenza Virus Vaccine
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 (2007-2008 Formulation)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation [ Time Frame: Days 0-3 post-dose ] [ Designated as safety issue: Yes ]
    Solicited injection site reactions: Erythema, swelling, pain/tenderness; Solicited systemic reactions: (for infants/toddlers) - fever, irritability, abnormal crying, drowsiness, lost appetite, vomiting; (for children) - fever, headache, malaise, myalgia) Note: Influenza-primed group received only dose 1.


Other Outcome Measures:
  • Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination [ Time Frame: Day 0 and Day 14 after last dose of Fluzone ] [ Designated as safety issue: No ]
  • Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection) [ Time Frame: Day 14 post-vaccination ] [ Designated as safety issue: No ]
    Seroprotection was defined as a serum hemagglutination inhibition antibody titer ≥40.

  • Seroconversion Rates for Each Influenza Antigen Post-Vaccination [ Time Frame: Day 14 post-vaccination ] [ Designated as safety issue: No ]
    Seroconversion was defined as a post-vaccination titer ≥ 40 for participants with a titer < 10 on Day 0 and a ≥4-fold increase for participants with a titer ≥ 10 on Day 0.


Enrollment: 34
Study Start Date: October 2007
Study Completion Date: June 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Influenza vaccine Naive/Inadequately Primed
Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
Biological: 2007-2008 Influenza Virus Vaccine
0.25 mL, Intramuscular
Other Name: Fluzone®
Experimental: Influenza Vaccine Primed
Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
Biological: 2007-2008 Influenza Virus Vaccine
0.25 mL, Intramuscular
Other Name: Fluzone®

  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 (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 or planned 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.
  • Received any vaccinations within the preceding 14 days (enrollment may be deferred).
  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: NCT00561002

Locations
United States, Virginia
Norfolk, Virginia, United States
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: NCT00561002     History of Changes
Other Study ID Numbers: GRC38
Study First Received: November 19, 2007
Results First Received: July 20, 2009
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Influenza Vaccine
Influenza Virus
Orthomyxoviridae Infections
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 20, 2014