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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: Influenza Virus Vaccine, Fluzone® (Biological); Influenza Virus Vaccine, Fluzone® (Biological)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi Pasteur, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: sanofi pasteur Inc

Summary

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

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Percentage of Seroprotected Participants Post-vaccination With Fluzone®

Secondary outcome: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®

Eligibility

Minimum age: 11 Months. Maximum age: 14 Months. Gender(s): Both.

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.

Locations and Contacts

Layton, Utah 84041, United States

Pleasant Grove, Utah 84062, United States

Provo, Utah 84604, United States

Salt Lake City, Utah 84107, United States

South Jordan, Utah 84095, United States

Additional Information

Starting date: October 2006
Last updated: January 16, 2014

Page last updated: August 20, 2015

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