Safety and Immunogenicity of 2 Commercially Available Influenza Vaccines in Children

Novartis

Status and phase

Completed

Phase 2

Conditions

Influenza

Treatments

Biological: Influenza vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00408395

V70P2

2006-003181-34

Details and patient eligibility

About

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

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

Enrollment

281 patients

Sex

All

Ages

6 to 35 months old

Volunteers

Accepts Healthy Volunteers

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