Status:
COMPLETED
Safety and Immunogenicity of Inactivated Influenza Virus Vaccine Among Healthy Children 6-12 Weeks of Age
Lead Sponsor:
Seattle Children's Hospital
Collaborating Sponsors:
Sanofi Pasteur, a Sanofi Company
Conditions:
Inactivated Influenza Vaccine
Eligibility:
All Genders
42-84 years
Phase:
PHASE2
PHASE3
Brief Summary
Study of the safety and immunogenicity (antibody producing capability) comparing inactivated influenza vaccine to placebo given to infants at 2 and 3 months of age. Infants will receive inactivated in...
Detailed Description
Methods: A double-blind, randomized, placebo-controlled trial was conducted in 1375 healthy US infants 6-12 weeks of age. Subjects received either 2 doses of trivalent inactivated influenza vaccine (T...
Eligibility Criteria
Inclusion
- Age 42 to 84 days on the day of inclusion
- Full term (born at \>=36 weeks with birth weight \>=2.5 kg
- Considered to be in good health
- Parental consent obtained and available
- Available for the study duration (6 months)
Exclusion
- Reported allergy to egg proteins, chicken proteins
- Previous history of influenza vaccination or disease
- Receipt of any vaccine other than Hepatitis B prior to enrollment
- Acute illness with rectal temperature \>= 38.0 (defer enrollment)
- Known bleeding disorder
- Participation in other interventional clinical trial within 30 days prior to enrollment
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
1375 Patients enrolled
Trial Details
Trial ID
NCT00242424
Start Date
September 1 2005
End Date
September 1 2007
Last Update
January 28 2009
Active Locations (1)
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1
Seattle Children's Hospital and Regional Medical Center
Seattle, Washington, United States, 98105