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

This study has been completed.

First Received: April 3, 2006 Last Updated: September 13, 2006 History of Changes

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00311428

Purpose

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

Condition	Intervention	Phase
Influenza	Biological: Influenza	Phase IV

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Novartis:

Primary Outcome Measures:

Seroprotection, GMR's and Seroconversion rate at day 0 and day 50 following vaccination.

Secondary Outcome Measures:

Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Thought the Study.

Estimated Enrollment:	270
Study Start Date:	October 2005

Eligibility

Ages Eligible for Study:	6 Months to 35 Months
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311428

Locations

Finland
University of Tampere Medical School
Tampere, Finland

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines Information Services

Novartis Vaccines & Diagnostics

More Information

No publications provided

Study ID Numbers:	M71P1, EUDRACT: 2004-001952-35
Study First Received:	April 3, 2006
Last Updated:	September 13, 2006
ClinicalTrials.gov Identifier:	NCT00311428 History of Changes
Health Authority:	Finland: National Agency for Medicines

Keywords provided by Novartis:

Influenza
Children
Vaccine

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Healthy
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009