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Safety and Immunogenicity of 2 Commercially Available Influenza Vaccines in Children

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ClinicalTrials.gov Identifier: NCT00408395
Recruitment Status : Completed
First Posted : December 6, 2006
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

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

Condition or disease Intervention/treatment Phase
Influenza Biological: Influenza vaccine Phase 2

Detailed 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 281 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : November 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: 1: Trivalent Seasonal Influenza Vaccine Biological: Influenza vaccine
Seasonal Influenza Vaccine
Experimental: 2: Adjuvanted Trivalent Seasonal Influenza Vaccine Biological: Influenza vaccine
Seasonal Influenza Vaccine



Primary Outcome Measures :
  1. To evaluate the immunogenicity of the 2 vaccines in terms of post-immunization geometric mean titers (GMTs), as measured by the hemagglutination inhibition (HI) test

Secondary Outcome Measures :
  1. To evaluate the immunogenicity of the 2 vaccines in terms of seroprotection, and seroconversion or significant increase, as measured by HI test
  2. To evaluate the safety and tolerability of the 2 vaccines administered 4 weeks apart


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Ages Eligible for Study:   6 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT00408395


Locations
Finland
University of Tampere Medical School
Tampere, Finland, 33014
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines (formerly Chiron Vaccines) Novartis

Publications of Results:
Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00408395     History of Changes
Other Study ID Numbers: V70P2
2006-003181-34
First Posted: December 6, 2006    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: December 2011

Keywords provided by Novartis ( Novartis Vaccines ):
influenza
children
vaccine
influenza disease

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