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NCT00311428 Clinical Trial

Safety and Immunogenicity of Three Commercially Available Influenza Vaccines in Children Aged 6 to <36 Months

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00311428
Other study ID # M71P1
Secondary ID EUDRACT: 2004-00
Status Completed
Phase Phase 4
First received April 3, 2006
Last updated September 13, 2006
Start date October 2005

Study information
Verified date September 2006
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Finland: Finnish Medicines Agency
Study type Interventional

Clinical Trial 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 to 35 months

Recruitment information / eligibility
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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• Influenza

Locations
Country Name City State
Finland University of Tampere Medical School Tampere

Sponsors (2)
Lead Sponsor Collaborator
Novartis Novartis Vaccines

Country where clinical trial is conducted

Finland, 

Outcome
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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