Safety and Immunogenicity of Fluzone® Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00390884
First received: October 20, 2006
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

To compare the groups with respect to influenza immune responses following Dose 1 of Fluzone vaccine (2006-2007 formulation).


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: Safety and Immunogenicity of Fluzone® Influenza Virus Vaccine (2006-2007 Formulation) Among Healthy Children Immunized in Fall 2005 With Fluzone Vaccine or Placebo

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percentage of Seroprotected Participants Post-vaccination With Fluzone® [ Time Frame: Day 28 Post-vaccination ] [ Designated as safety issue: No ]
    Seroprotection was defined as a Post-vaccination Hemagglutination Inhibition titer of greater than or equal to 1:40.


Secondary Outcome Measures:
  • Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone® [ Time Frame: Day 28 Post-vaccination ] [ Designated as safety issue: No ]
    Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.


Other Outcome Measures:
  • Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® [ Time Frame: Days 0-7 Post-vaccination ] [ Designated as safety issue: Yes ]
    Solicited injection site: tenderness, erythema, and swelling; Solicited systemic reactions: fever, vomiting, abnormal crying, drowsiness, appetite loss, and irritability, after each vaccination


Enrollment: 173
Study Start Date: October 2006
Study Completion Date: September 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluzone®-Primed Group
Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28, NCT00242424), will receive 2 doses of Fluzone® Pediatric 2006-2007 formulation.
Biological: Influenza Virus Vaccine, Fluzone®
0.25 mL, Intramuscular
Other Name: Fluzone®
Experimental: Fluzone®-Naive Group
Participants had never received Influenza vaccine and had received two doses of placebo in the fall of 2005 (Study GRC28, NCT00242424), will receive 2 doses of Fluzone® Pediatric 2006-2007 formulation.
Biological: Influenza Virus Vaccine, Fluzone®
0.25 mL, Intramuscular
Other Name: Fluzone®

  Eligibility

Ages Eligible for Study:   11 Months to 14 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Previously enrolled in study GRC28 and received 2 vaccinations of the assigned lot.
  • Considered to be in good health on the basis of reported medical history and history-directed physical evaluation.
  • Available for the duration of the study.
  • Parent/legal representative willing and able to provide informed consent.
  • Parent/legal representative able to attend all scheduled visits and comply with all trial procedures.
  • Parent/legal representative willing to permit venipuncture for purposes of collecting a blood sample.

Exclusion Criteria :

  • Receipt of any vaccine within the past 7 days (subjects may be deferred until after the seven days has passed.)
  • Reported allergy to egg proteins, chicken proteins or any other constituent of the vaccine.
  • Ever received any influenza vaccine, other than at Visits 1 and 2 of study GRC28, or known to have ever been diagnosed with laboratory-confirmed influenza.
  • An acute illness with fever (rectal temperature ≥ 100.4°F [38.0°C]) in the 72 hours preceding enrollment in the trial (defer enrollment).
  • Known bleeding disorder.
  • Participation in any other interventional clinical trial within 30 days prior to enrollment, or planned participation in another interventional clinical trial prior 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 that, in the opinion of the investigator, could interfere with trial conduct or completion.
  • Known Human Immunodeficiency Virus (HIV)-positive mother or Hepatitis B surface antigen (HBsAg)-positive mother.
  • Known HIV, Hepatitis B, or Hepatitis C infection.
  • Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
  • Prior personal history of Guillain-Barré syndrome.
  • Any condition that, 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: NCT00390884

Locations
United States, Utah
Layton, Utah, United States, 84041
Pleasant Grove, Utah, United States, 84062
Provo, Utah, United States, 84604
Salt Lake City, Utah, United States, 84107
South Jordan, Utah, United States, 84095
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: NCT00390884     History of Changes
Other Study ID Numbers: GRC29
Study First Received: October 20, 2006
Results First Received: September 21, 2009
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Fluzone®
Influenza
Influenza virus infection
Influenza vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014