Clinical trial NCT00390884: Safety and Immunogenicity of Fluzone® Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Fluzone®
Influenza
Influenza virus infection
Influenza vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-10-23
Enrollment: 173
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility 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.

Primary outcomes:
measure: Percentage of Seroprotected Participants Post-vaccination With Fluzone®
timeFrame: Day 28 Post-vaccination
Secondary outcomes:
measure: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®
timeFrame: Day 28 Post-vaccination
Other outcomes:
measure: Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
timeFrame: Days 0-7 Post-vaccination
Locations:
city: Layton
country: United States
state: Utah
city: Pleasant Grove
country: United States
state: Utah
city: Provo
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: South Jordan
country: United States
state: Utah
Study officials:
affiliation: sanofi pasteur Inc
name: Medical Director
role: STUDY_DIRECTOR
References: