Safety and Immunogenicity of 2 Commercially Available Influenza Vaccines in Children

Novartis Vaccines281 enrolled

Overview

This is a study of the safety and immunogenicity of three commercially available influenza vaccines in children.

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 available influenza vaccine versus Two 0.25 mL Intramuscular Doses of a commercially available influenza vaccine in Healthy Children

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

281

Conditions

Influenza

Interventions

Influenza vaccineBIOLOGICAL

Seasonal Influenza Vaccine

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 35 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 6 months to \< 36 months of age 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, 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

Locations (1)

University of Tampere Medical School

Tampere, Finland

Outcomes

Primary Outcomes

To evaluate the immunogenicity of the 2 vaccines in terms of post-immunization geometric mean titers (GMTs), as measured by the hemagglutination inhibition (HI) test

Secondary Outcomes

To evaluate the immunogenicity of the 2 vaccines in terms of seroprotection, and seroconversion or significant increase, as measured by HI test

To evaluate the safety and tolerability of the 2 vaccines administered 4 weeks apart

Data from ClinicalTrials.gov

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