Back to resultsSafety and Immunogenicity of 2 Commercially Available Influenza Vaccines in Children
Primary Purpose
Influenza
Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
Influenza vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring influenza, children, vaccine, influenza disease
Eligibility 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
Sites / Locations
- University of Tampere Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1: Trivalent Seasonal Influenza Vaccine
2: Adjuvanted Trivalent Seasonal Influenza Vaccine
Arm Description
Outcomes
Primary Outcome Measures
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
To evaluate the immunogenicity of the 2 vaccines in terms of seroprotection, and seroconversion or significant increase, as measured by HI test
To evaluate the safety and tolerability of the 2 vaccines administered 4 weeks apart
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00408395
Brief Title
Safety and Immunogenicity of 2 Commercially Available Influenza Vaccines in Children
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 Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
4. Oversight
5. Study Description
Brief Summary
This is a study of the safety and immunogenicity of three commercially available influenza vaccines in children.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
influenza, children, vaccine, influenza disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
281 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1: Trivalent Seasonal Influenza Vaccine
Arm Type
Experimental
Arm Title
2: Adjuvanted Trivalent Seasonal Influenza Vaccine
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Influenza vaccine
Intervention Description
Seasonal Influenza Vaccine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To evaluate the immunogenicity of the 2 vaccines in terms of seroprotection, and seroconversion or significant increase, as measured by HI test
Title
To evaluate the safety and tolerability of the 2 vaccines administered 4 weeks apart
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
35 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines (formerly Chiron Vaccines)
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
University of Tampere Medical School
City
Tampere
ZIP/Postal Code
33014
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
19561422
Citation
Vesikari T, Pellegrini M, Karvonen A, Groth N, Borkowski A, O'Hagan DT, Podda A. Enhanced immunogenicity of seasonal influenza vaccines in young children using MF59 adjuvant. Pediatr Infect Dis J. 2009 Jul;28(7):563-71. doi: 10.1097/INF.0b013e31819d6394.
Results Reference
result
Learn more about this trial
Safety and Immunogenicity of 2 Commercially Available Influenza Vaccines in Children
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