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

Novartis

Status and phase

Completed

Phase 4

Conditions

Influenza

Treatments

Biological: Influenza

Study type

Interventional

Funder types

Industry

Identifiers

NCT00311428

EUDRACT: 2004-001952-35

M71P1

Details and patient eligibility

About

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

Sex

All

Ages

6 to 35 months old

Volunteers

No Healthy Volunteers

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