Back to resultsSafety and Immunogenicity of One Dose of an Inactivated Trivalent Sub-unit Influenza Vaccine Administered to Non-elderly Adult and Elderly Subjects
Primary Purpose
Influenza
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Seasonal Influenza Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Seasonal Influenza, vaccine
Eligibility Criteria
Inclusion Criteria:
Healthy, adult and elderly volunteers over 18 years
Exclusion Criteria:
Individuals with any serious chronic or acute disease or known or suspected impairment of the immune system.
Sites / Locations
- Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio
- Dipartimento di Scienze della Salute Università di Genova
- Distretto Sanitario di Base di Fossacesia
- ASL Lanciano - Vasto,
- Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute
- Dipartimento di malattie infettive Ospedale San Gerardo
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit
Outcomes
Primary Outcome Measures
To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in adult and elderly
To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) and/or HI at 21 days post-immunization in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01357265
Brief Title
Safety and Immunogenicity of One Dose of an Inactivated Trivalent Sub-unit Influenza Vaccine Administered to Non-elderly Adult and Elderly Subjects
Official Title
A Phase II Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface, Antigen, Inactivated, Influenza Vaccine, Formulation 2011/2012, When Administered to Adult and Elderly Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
4. Oversight
5. Study Description
Brief Summary
This study will evaluate safety and immunogenicity of a sub-unit Influenza vaccine when administered to adult and elderly subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Seasonal 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
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit
Intervention Type
Biological
Intervention Name(s)
Seasonal Influenza Vaccine
Intervention Description
This phase II is performed as a multicenter study in adult and elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated flu vaccine during the vaccination visit, according to the study protocol (follow-up period: until day 22) .
Primary Outcome Measure Information:
Title
To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in adult and elderly
Description
To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) and/or HI at 21 days post-immunization in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.
Time Frame
22 days including follow-up period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy, adult and elderly volunteers over 18 years
Exclusion Criteria:
Individuals with any serious chronic or acute disease or known or suspected impairment of the immune system.
Facility Information:
Facility Name
Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio
City
Via Dei Vestini
State/Province
Cheiti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Dipartimento di Scienze della Salute Università di Genova
City
Via Pastore
State/Province
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Distretto Sanitario di Base di Fossacesia
City
Via Polidoro-Vasto
State/Province
Lanciano
Country
Italy
Facility Name
ASL Lanciano - Vasto,
City
Via S. Spaventa
State/Province
Lanciano
ZIP/Postal Code
66034
Country
Italy
Facility Name
Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute
City
Via Stamira d'Ancona
State/Province
Milano
ZIP/Postal Code
20127
Country
Italy
Facility Name
Dipartimento di malattie infettive Ospedale San Gerardo
City
Via Pergolesi 33
State/Province
Monza
ZIP/Postal Code
20052
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Safety and Immunogenicity of One Dose of an Inactivated Trivalent Sub-unit Influenza Vaccine Administered to Non-elderly Adult and Elderly Subjects
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