Back to resultsA Dose Ranging Study Comparing Different Combinations of Adjuvanted and Non-adjuvanted Influenza Vaccines in Healthy Children 6 to <36 Months of Age
Primary Purpose
Influenza
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Adjuvanted and un-adjuvanted influenza vaccines
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, Flu, Vaccine, Adjuvant
Eligibility Criteria
Inclusion Criteria:
- Children of 6 month to <36 month of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator.
Exclusion Criteria:
- History of serious disease. History of serious reaction following administration of vaccine or hypersensitivity to vaccine components. Known or suspected impairment/alteration of immune function.
Sites / Locations
- UCL St. Luc - Pharmacy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.
Secondary Outcome Measures
Strain-specific influenza antibody titers will be used to assess Immunogenicity
Full Information
NCT ID
NCT00848887
First Posted
February 19, 2009
Last Updated
January 23, 2014
Sponsor
Novartis
Collaborators
Novartis Vaccines
1. Study Identification
Unique Protocol Identification Number
NCT00848887
Brief Title
A Dose Ranging Study Comparing Different Combinations of Adjuvanted and Non-adjuvanted Influenza Vaccines in Healthy Children 6 to <36 Months of Age
Official Title
A Phase Ib, Randomized, Observer-Blind, Multicenter, Factorial-Design Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Injections of Trivalent Inactivated Influenza Vaccine With or Without a Second Influenza B Strain in Combination With or Without One of Three Different Doses of Adjuvant in Healthy Children, Aged 6 to <36 Months
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
Collaborators
Novartis Vaccines
4. Oversight
5. Study Description
Brief Summary
This study will evaluate the safety and immunogenicity of different combinations of influenza vaccine in healthy young children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Flu, Vaccine, Adjuvant
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
410 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Adjuvanted and un-adjuvanted influenza vaccines
Intervention Description
16 different formulations of trivalent influenza vaccine and 1 marketed influenza vaccine comparator.
Primary Outcome Measure Information:
Title
Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.
Time Frame
50 days
Secondary Outcome Measure Information:
Title
Strain-specific influenza antibody titers will be used to assess Immunogenicity
Time Frame
50 days
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:
Children of 6 month to <36 month of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator.
Exclusion Criteria:
History of serious disease. History of serious reaction following administration of vaccine or hypersensitivity to vaccine components. Known or suspected impairment/alteration of immune function.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
UCL St. Luc - Pharmacy
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
21906647
Citation
Della Cioppa G, Vesikari T, Sokal E, Lindert K, Nicolay U. Trivalent and quadrivalent MF59((R))-adjuvanted influenza vaccine in young children: a dose- and schedule-finding study. Vaccine. 2011 Nov 3;29(47):8696-704. doi: 10.1016/j.vaccine.2011.08.111. Epub 2011 Sep 9.
Results Reference
result
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A Dose Ranging Study Comparing Different Combinations of Adjuvanted and Non-adjuvanted Influenza Vaccines in Healthy Children 6 to <36 Months of Age
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