Status:
COMPLETED
Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 Months of Age
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Influenza
Eligibility:
All Genders
2-9 years
Phase:
PHASE1
PHASE2
Brief Summary
Primary Objective: To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the package ...
Detailed Description
This is an observational and descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children aged 6 to 12 weeks (the inve...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Aged 42 to 84 days (6 to 12 weeks) or 24 to 36 weeks on the day of inclusion.
- Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg.
- Considered to be in good health on the basis of reported medical history and history-directed physical examination.
- Available for the duration of the study.
- Parent/guardian willing and able to provide informed consent.
- Parent/guardian able to attend all scheduled visits and comply with all trial procedures.
- Willingness to permit venipuncture or heel stick for purposes of collecting a blood sample.
- Exclusion Criteria :
- Reported allergy to egg proteins, chicken proteins or any other constituent of the vaccine.
- Previous history of influenza vaccination or documented history of influenza infection.
- Receipt of any vaccine in the 7 days prior to enrollment.
- An acute illness with fever (rectal temperature ≥ 38.0 °C \[or ≥ 100.4 °F\]) in the 72 hours preceding enrollment in the trial (defer enrollment).
- Known bleeding disorder.
- Participation in any other clinical trial within 30 days prior to enrollment, or planned participation in another clinical trial prior to termination of the subject's participation in this 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 could interfere with trial conduct or completion.
- Known HIV-positive or HBsAg-positive mother.
- Known HIV, hepatitis B (HBsAg), or hepatitis C infection.
- Blood or blood-derived products received in the past 2 months.
- Prior 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.
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
394 Patients enrolled
Trial Details
Trial ID
NCT00858468
Start Date
April 1 2005
End Date
December 1 2006
Last Update
April 14 2016
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Little Rock, Arkansas, United States, 72205
2
Marietta, Georgia, United States, 30062
3
Durham, North Carolina, United States, 27705
4
Akron, Ohio, United States, 44308