Safety and Immunogenicity of 2 Commercially Available Influenza Vaccines in Children
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
2 other identifiers
interventional
281
1 country
1
Brief Summary
This is a study of the safety and immunogenicity of three commercially available influenza vaccines in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2006
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 5, 2006
CompletedFirst Posted
Study publicly available on registry
December 6, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedDecember 1, 2016
December 1, 2011
9 months
December 5, 2006
November 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (2)
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
Study Arms (2)
1: Trivalent Seasonal Influenza Vaccine
EXPERIMENTAL2: Adjuvanted Trivalent Seasonal Influenza Vaccine
EXPERIMENTALInterventions
Seasonal Influenza Vaccine
Eligibility Criteria
You may qualify if:
- months to \< 36 months of age
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Tampere Medical School
Tampere, 33014, Finland
Related Publications (1)
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.
PMID: 19561422RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis Vaccines (formerly Chiron Vaccines)
Novartis
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2006
First Posted
December 6, 2006
Study Start
November 1, 2006
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
December 1, 2016
Record last verified: 2011-12