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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00311428
Recruitment Status : Completed
First Posted : April 6, 2006
Last Update Posted : September 14, 2006
Novartis Vaccines
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Brief Summary:
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 or disease Intervention/treatment Phase
Influenza Biological: Influenza Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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.
Study Start Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Primary Outcome Measures :
  1. Seroprotection, GMR's and Seroconversion rate at day 0 and day 50 following vaccination.

Secondary Outcome Measures :
  1. Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Thought the Study.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 35 Months   (Child)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00311428

University of Tampere Medical School
Tampere, Finland
Sponsors and Collaborators
Novartis Vaccines
Study Chair: Novartis Vaccines Information Services Novartis Vaccines & Diagnostics Identifier: NCT00311428     History of Changes
Other Study ID Numbers: M71P1
EUDRACT: 2004-001952-35
First Posted: April 6, 2006    Key Record Dates
Last Update Posted: September 14, 2006
Last Verified: September 2006

Keywords provided by Novartis:

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs