Back to resultsImmunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Formulation 2007-2008
Primary Purpose
Influenza
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Surface antigen inactivated influenza vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza vaccine
Eligibility Criteria
Inclusion Criteria:
- Healthy Subjects eligible for enrollment into this study are male and female adult volunteers
Exclusion Criteria:
- Any serious disease
Sites / Locations
- The Health Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1: Fluvirin
Arm Description
Outcomes
Primary Outcome Measures
evaluate the antibody response to each influenza vaccine antigen
Secondary Outcome Measures
Safety and tolerability of the study vaccine in the study population
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00518453
Brief Title
Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Formulation 2007-2008
Official Title
A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Ph.Eur, Formulation 2007-2008, When Administered to Non-Elderly Adult and Elderly Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
July 2007 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO and CPMP recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly adults and elderly subjects (CPMP/BWP/214/96).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Fluvirin
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Surface antigen inactivated influenza vaccine
Intervention Description
1 dose of Fluvirin 2007/2008 Northern Hemisphere vaccine composition
Primary Outcome Measure Information:
Title
evaluate the antibody response to each influenza vaccine antigen
Time Frame
21 days post-immunization
Secondary Outcome Measure Information:
Title
Safety and tolerability of the study vaccine in the study population
Time Frame
Throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy Subjects eligible for enrollment into this study are male and female adult volunteers
Exclusion Criteria:
Any serious disease
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
The Health Centre
City
Suffolk
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Formulation 2007-2008
We'll reach out to this number within 24 hrs