Status:
COMPLETED
Safety and Immunogenicity of Three Commercially Available Influenza Vaccines in Children Aged 6 to <36 Months
Lead Sponsor:
Novartis
Collaborating Sponsors:
Novartis Vaccines
Conditions:
Influenza
Eligibility:
All Genders
6-35 years
Phase:
PHASE4
Brief Summary
This phase IV protocol is designed to evaluate the safety, clinical tolerability and immunogenicity of the 2005-2006 formulation of three widely used conventional influenza vaccines in children aged 6...
Eligibility Criteria
Inclusion
- children of 6 months to \<36 months of age, whose parents or legal guardians have given written informed consent prior to study entry
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, 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 :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00311428
Start Date
October 1 2005
Last Update
September 14 2006
Active Locations (1)
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1
University of Tampere Medical School
Tampere, Finland