Back to resultsSafety and Immunogenicity of Trivalent Split Influenza Vaccine Using the Strain Composition 2007/2008
Primary Purpose
Seasonal Influenza, Vaccine
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
trivalent split influenza vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Seasonal Influenza focused on measuring influenza vaccine
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
- available for all the visits scheduled in the study and able to comply with all study requirements
- in good health as determined by: medical history, physical examination, clinical judgment of the investigator
Exclusion Criteria:
- n/a
Sites / Locations
- Werksarztzentrum Herborn
Outcomes
Primary Outcome Measures
evaluate the antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21
evaluate safety of trivalent split influenza vaccine
Secondary Outcome Measures
Full Information
NCT ID
NCT00498303
First Posted
July 9, 2007
Last Updated
April 21, 2008
Sponsor
Novartis
Collaborators
Novartis Vaccines
1. Study Identification
Unique Protocol Identification Number
NCT00498303
Brief Title
Safety and Immunogenicity of Trivalent Split Influenza Vaccine Using the Strain Composition 2007/2008
Official Title
A Phase III, Multicenter, Uncontrolled, Open-Label Study to Evaluate Safety and Immunogenicity of Preservative Free, Inactivated Split Influenza Vaccine, Using the Strain Composition 2007/2008 When Administered to Adult and Elderly Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
Collaborators
Novartis Vaccines
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Annual trial for registration of trivalent split influenza vaccine with the strain composition of the season 2007/2008 in healthy adult and elderly subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Influenza, Vaccine
Keywords
influenza vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
trivalent split influenza vaccine
Primary Outcome Measure Information:
Title
evaluate the antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21
Title
evaluate safety of trivalent split influenza vaccine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
available for all the visits scheduled in the study and able to comply with all study requirements
in good health as determined by: medical history, physical examination, clinical judgment of the investigator
Exclusion Criteria:
n/a
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
Werksarztzentrum Herborn
City
Herborn
ZIP/Postal Code
35745
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Safety and Immunogenicity of Trivalent Split Influenza Vaccine Using the Strain Composition 2007/2008
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