Back to resultsSafety and Immunogenicity of a Booster Dose of -H5N1 Influenza Vaccine
Primary Purpose
Avian Influenza
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
H5N1 influenza vaccine
H5N1 influenza vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Avian Influenza focused on measuring H5N1 Pandemic
Eligibility Criteria
Inclusion Criteria:
- Healthy subjects who previously participated in study V87P1, but did not receive the booster dose on day 202
Exclusion Criteria:
- Pregnant or breastfeeding
- Receipt of another vaccine or any investigational agent within the past 4 weeks
- Surgery planned during the study period
Sites / Locations
- Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via dei Vestini
- 01: Dipartimento di Scienze della Salute, Sezione Igiene e Medicina Preventiva, Università di Genova
- 03: Ufficio di Igiene e Sanità Pubblica di Lanciano, ASL Lanciano -Vasto, Via Spaventa, 37,
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Number and percentage of subjects with at least one local reaction between 1 and 7 days after vaccination.
Number and percentage of subjects with at least one systemic reaction between 1 and 7 days after vaccination.
Secondary Outcome Measures
Number and percentage of subjects with at least one adverse event between day of vaccination and the study termination visit.Safety will be assessed in accordance with available safety data on influenza vaccines.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00561184
Brief Title
Safety and Immunogenicity of a Booster Dose of -H5N1 Influenza Vaccine
Official Title
A Phase II, Open-label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Booster Dose of -H5N1 (Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccine in Non-elderly Adult and Elderly Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
June 2008 (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
To assess persistence of antibody titers 17-18 months after primary immunization with two 0.5mL intramuscular (IM) doses of H5N1 influenza vaccine containing H5N1 influenza antigen, as measured by Hemagglutination Inhibition (HI), Single Radial Hemolysis (SRH), and Microneutralization (MN) test
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Avian Influenza
Keywords
H5N1 Pandemic
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
H5N1 influenza vaccine
Intervention Description
One 0.5 ml booster injection 12 months after the second injection, of influenza vaccine containing 7.5 micrograms of H5N1 influenza antigen
Intervention Type
Biological
Intervention Name(s)
H5N1 influenza vaccine
Intervention Description
One 0.5 ml booster injection 12 months after the second injection, of influenza vaccine containing 15.0 micrograms of H5N1 influenza antigen
Primary Outcome Measure Information:
Title
Number and percentage of subjects with at least one local reaction between 1 and 7 days after vaccination.
Time Frame
7 days
Title
Number and percentage of subjects with at least one systemic reaction between 1 and 7 days after vaccination.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Number and percentage of subjects with at least one adverse event between day of vaccination and the study termination visit.Safety will be assessed in accordance with available safety data on influenza vaccines.
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy subjects who previously participated in study V87P1, but did not receive the booster dose on day 202
Exclusion Criteria:
Pregnant or breastfeeding
Receipt of another vaccine or any investigational agent within the past 4 weeks
Surgery planned during the study period
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
Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via dei Vestini
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
01: Dipartimento di Scienze della Salute, Sezione Igiene e Medicina Preventiva, Università di Genova
City
Genova
ZIP/Postal Code
16129
Country
Italy
Facility Name
03: Ufficio di Igiene e Sanità Pubblica di Lanciano, ASL Lanciano -Vasto, Via Spaventa, 37,
City
Lanciano
ZIP/Postal Code
66034
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
20810680
Citation
Fragapane E, Gasparini R, Schioppa F, Laghi-Pasini F, Montomoli E, Banzhoff A. A heterologous MF59-adjuvanted H5N1 prepandemic influenza booster vaccine induces a robust, cross-reactive immune response in adults and the elderly. Clin Vaccine Immunol. 2010 Nov;17(11):1817-9. doi: 10.1128/CVI.00461-09. Epub 2010 Sep 1.
Results Reference
result
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Safety and Immunogenicity of a Booster Dose of -H5N1 Influenza Vaccine
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