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

October 20, 2006
January 16, 2014
October 2006
June 2007   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00390884 on ClinicalTrials.gov Archive Site
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.
Not Provided
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
Not Provided
 
Safety and Immunogenicity of Fluzone® Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation.
Safety and Immunogenicity of Fluzone® Influenza Virus Vaccine (2006-2007 Formulation) Among Healthy Children Immunized in Fall 2005 With Fluzone Vaccine or Placebo

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

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Influenza
Biological: Influenza Virus Vaccine, Fluzone®
0.25 mL, Intramuscular
Other Name: Fluzone®
  • 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.
    Intervention: Biological: Influenza Virus Vaccine, 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.
    Intervention: Biological: Influenza Virus Vaccine, Fluzone®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
173
September 2008
June 2007   (final data collection date for primary outcome measure)

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.
Both
11 Months to 14 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00390884
GRC29
No
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director sanofi pasteur Inc
Sanofi
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP