Influenza Clinical Trial
Official title:
A Phase IV, Observer-Blind, Randomized, Parallel Groups, Single-Center, Exploratory Clinical Study to Evaluate the Immunogenicity and Safety of Two 0.25 mL Intramuscular Doses of Three Commercially Available Influenza Vaccines in Healthy Subjects Aged 6 to <36 Months.
Verified date | September 2006 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Finnish Medicines Agency |
Study type | Interventional |
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 to 35 months
Status | Completed |
Enrollment | 270 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | |
Gender | Both |
Age group | 6 Months to 35 Months |
Eligibility |
Inclusion Criteria: - children of 6 months to <36 months of age, whose parents or legal guardians have given written informed consent prior to study entry Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Finland | University of Tampere Medical School | Tampere |
Lead Sponsor | Collaborator |
---|---|
Novartis | Novartis Vaccines |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Seroprotection, GMR's and Seroconversion rate at day 0 and day 50 following vaccination. | |||
Secondary | Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Thought the Study. |
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