Status:
COMPLETED
Safety and Immunogenicity of 2 Commercially Available Influenza Vaccines in Children
Lead Sponsor:
Novartis Vaccines
Conditions:
Influenza
Eligibility:
All Genders
6-35 years
Phase:
PHASE2
Brief Summary
This is a study of the safety and immunogenicity of three commercially available influenza vaccines in children.
Detailed Description
A Phase II, Observer-Blind, Randomized, Parallel Groups, Multicenter, Exploratory Clinical Study to Evaluate the Immunogenicity and Safety of One and Two 0.25 mL Intramuscular Doses of a commercially ...
Eligibility Criteria
Inclusion
- 6 months to \< 36 months of age
Exclusion
- Any severe acute respiratory disease and infections requiring systemic antibiotic or antiviral therapy ongoing or resolved within 30 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable)
- Other serious diseases such as: cancer, autoimmune disease (including rheumatoid arthritis), diabetes mellitus, chronic pulmonary disease, acute or progressive hepatic or renal disease, or surgery planned during the study period.
- Known or suspected impairment/alteration of immune function
- History of hypersensitivity to any component of the study vaccine, egg products or other vaccine component, or impairment/alteration of immune function
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
281 Patients enrolled
Trial Details
Trial ID
NCT00408395
Start Date
November 1 2006
End Date
August 1 2007
Last Update
December 1 2016
Active Locations (1)
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1
University of Tampere Medical School
Tampere, Finland, 33014