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

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00311428
First received: April 3, 2006
Last updated: September 13, 2006
Last verified: September 2006
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
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.

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

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

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

Keywords provided by Novartis:
Influenza
Children
Vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013